Impella 0048-0045Recalls & reported problems

Summary

The FDA's MAUDE database contains 11,112 adverse event reports that list this exact device (DI 00813502011876), received between Dec 17, 2021 and Aug 18, 2026 — classified as 1,269 deaths, 6,852 injuries, 2,991 malfunctions.

The most frequently reported specific device problem is “Restricted Flow rate” (1,066 reports).

5 FDA recall records name this device's identifier, 5 still open.

21 other recalls cover devices cleared under the same FDA submission (P140003); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jun 11, 2026Open, Classified

   A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.

   Z-2682-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Aug 5, 2024Open, Classified

   A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.

   Z-2959-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Dec 27, 2023Open, Classified

   New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device.

   Z-1074-2024 · Root cause: Labeling Change Control · Recall details · FDA record ↗

4. Dec 27, 2023Open, Classified

   IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.

   Z-0980-2024 · Root cause: Labeling Change Control · Recall details · FDA record ↗

5. Jun 14, 2023Open, Classified

   There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.

   Z-2116-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 11,112 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Patient Device Interaction Problem

  An Impella CP device was inserted via the right femoral artery in a 79 year-old male patient undergoing a protected percutaneous coronary intervention (PPCI). The patient's clinical state prior to initiation of support was unknown for Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage. The patient's medical history was notable for coronary artery disease (CAD).During the procedure, single-access technique was utilized, and the patient remained on Impella support for approximately 2 hours. After the PPCI the device was successfully weaned and explanted. The activated clotting time (ACT) was reported at 306 seconds at the time of device removal. Post-procedure, a gradual decline in hemoglobin was observed, which the treating providers felt was likely related to the Impella. Hemoglobin decreased to 7.8 g/dL. Transfusion of 1 unit of packed red blood cells (PRBC) was given, with improvement to 9.3 g/dL was reported. No overt source of bleeding was identified. However, minor bleeding from an internal jugular (IJ) sheath was reported and managed with local epinephrine and lidocaine administration.Two days following the procedure, the patient experienced an asysto

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50300721 ↗
• MalfunctionAug 4, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50129768 ↗
• InjuryJul 31, 2026Device Sensing Problem; Patient Device Interaction Problem

  Impella CP was inserted percutaneously via right femoral artery access site in an 73-year-old female patient presenting with High-Risk Percutaneous Coronary Intervention (HRPCI). The patient¿s comorbidities included known coronary artery disease (CAD) and diabetes mellitus. The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage C. The patient was medically supported by inotropes, vasopressors.During support, the AO placement signal was observed at 98/70 mmHg and suddenly increased to 223/99 mmHg with a corresponding left ventricular placement signal increase to 235/38 mmHg. No changes were noted in pump performance, motor current, purge flow, purge pressure, or flow rate, which remained at 3.3 L/min at Performance(P) P8. The Clinical Support Center (CSC) was contacted and recommended echocardiographic evaluation to confirm device position and indicated suspicion of an optical sensor failure.Subsequently, the patient developed acute right-sided weakness and slurred speech, prompting a stroke alert. Neurological evaluation documented an National Institutes of Health (NIH) Stroke Scale score of 9 (cla

  Patient problems: Stroke/CVA

  MAUDE report 50099145 ↗
• InjuryJul 29, 2026Patient Device Interaction Problem

  An Impella CP device was inserted into the right femoral artery in a 77-year-old male patient presenting in acute myocardial infarction (AMI) and cardiogenic shock (CGS). The patient's clinical presentation was Society for Cardiovascular Angiography & Intervention (SCAI) stage D shock, on multiple inotropes and vasopressors, and on a ventilator for respiratory support, prior to initiation of support. The patient's comorbidities are unknown.On Day one of support, upon arrival to the intensive care unit (ICU), there was a hematoma noted in bilateral groins. Manual pressure was held, which resolved the issue. The patient received Brilinta 180mg for the procedure. The activated clotting time (ACT) was 289. The patient was hemodynamically stable with a blood pressure of 109/56.On Day 3 of support, there was reported gastrointestinal (GI) bleeding, which required the device to be removed.While on support, the Impella functioned as intended at performance (P) level P-6 at 2.6L/min with D5W Sodium Bicarbonate in the purge solution.Bleeding can be attributed to the anticoagulant and antiplatelet therapy required for the treatment of acute myocardial infarction and cardiogenic shock, includi

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50074709 ↗
• InjuryJun 18, 2026No Apparent Adverse Event; Patient Device Interaction Problem

  AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 35-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK, CLASSIFIED AS SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE E SHOCK. FOLLOWING CARDIOPULMONARY RESUSCITATION AND IMPELLA CP INSERTION, HEMOLYSIS WAS REPORTED AND NOTED TINGED URINE. IMAGING CONFIRMED APPROPRIATE PUMP POSITION AT THE TIME OF THE HEMOLYSIS. NO BLOOD PRODUCTS WERE ADMINISTERED. THE IMPELLA PURGE SOLUTION CONSISTED OF DEXTROSE 5% IN WATER WITH 25 MEQ SODIUM BICARBONATE. AT THE TIME OF THE EVENT, THE DEVICE WAS OPERATING AT APPROXIMATELY P-7 WITH FLOWS OF 3.4 L/MIN. THE PATIENT REMAINED ON IMPELLA CP SUPPORT AT THE TIME OF REPORTING.

  Patient problems: Cardiac Arrest; Hemolysis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25546041 ↗
• DeathJun 9, 2026Patient Device Interaction Problem

  AN IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY TO SUPPORT THE 71 YEAR OLD FEMALE PATIENT ADMITTED IN AFTER A ST- ELEVATION MYOCARDIAL INFARCTION, PRESENTING IN SCAI STAGE E SHOCK. THE PATIENT HAD ARRESTED IN THE FIELD AND BEEN GIVEN CPR BY THE EMERGENCY SERVICES. THE CP WAS PLACED AND THE CARDIAC TEAM PERFORMED PERCUTANEOUS CORONARY INTERVENTION. THE PATIENT WAS SUPPORTED BY THE CP PUMP, VASOPRESSIN, AND CALCIUM CHLORIDE. THE PATIENT WAS BEING TRANSFERRED FROM THE CATHETERIZATION LAB, AND BECAME BRADYCARDIC AND THEN WENT INTO PULSELESS ELECTRICAL ACTIVITY (PEA) AND WAS RETURNED TO THE LAB. ACLS PROTOCOLS WERE INITIATED AND EPINEPHRINE WAS GIVEN BUT PATIENT WAS UNABLE TO BE RESUSCITATED. THE PATIENT EXPIRED IN THE CATH LAB DESPITE ALL EFFORTS. THE DEATH IS CONSERVATIVELY BEING REPORTED TO THE IMPELLA CP BUT IS UNLIKELY RELATED AND IS MOST LIKELY ATTRIBUTED TO PATIENTS UNDERLYING CRITICAL CONDITION AS THEY PRESENTED IN SCAI STAGE E SHOCK AFTER A COMMUNITY ARREST WITH CPR/ACLS, AND WITH ONGOING HEMODYNAMIC INSTABILITY INCLUSIVE OF PEA AND NEED FOR ONGOING ACLS NEEDS/INTERVENTIONS.

  Patient problems: Bradycardia; Cardiac Arrest

  MAUDE report 25445375 ↗
• DeathJun 9, 2026Priming Problem

  CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 78-YEAR-OLD MALE PATIENT FOR THE INDICATION OF ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS). THE PATIENT¿S COMORBIDITIES WERE NOT REPORTED. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS CONSISTENT WITH SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE B CARDIOGENIC SHOCK. IT WAS NOTED THAT THE PATIENT ARRIVED IN CARDIAC ARREST. IT WAS REPORTED THAT THE FIRST IMPELLA CP PUMP WAS NOT PURGING CORRECTLY. IN RESPONSE TO THE REPORTED ISSUE, THE PHYSICIAN REQUESTED PLACEMENT OF A SECOND IMPELLA CP DEVICE, AND THE INITIAL DEVICE WAS REMOVED AND REPLACED. THE PATIENT REMAINED CRITICALLY ILL DESPITE ONGOING MECHANICAL CIRCULATORY SUPPORT AND SUBSEQUENTLY EXPIRED WHILE SUPPORTED ON THE SECOND IMPELLA CP DEVICE. NO ADVERSE EVENTS WERE REPORTED WITH THE SECOND IMPELLA CP. THE DEATH IS CONSERVATIVELY BEING REPORTED ON THE FIRST IMPELLA CP DEVICE DUE TO THE TEMPORAL ASSOCIATION WITH THE REPORTED PURGE ISSUE REQUIRING DEVICE REPLACEMENT. BASED ON THE AVAILABLE CLINICAL INFORMATION, THE OUTCOME IS MOST LIKELY ATTRIBUTABLE TO THE PATIENT'S UNDERLYING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25442818 ↗
• DeathJun 3, 2026Patient Device Interaction Problem

  AN IMPELLA DEVICE WAS INSERTED IN A 53-YEAR-OLD MALE WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD) AND RENAL INSUFFICIENCY. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT DURING A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI) ON (B)(6) 2024. AFTER THE IMPELLA WAS INSERTED, THE PATIENT EXPERIENCED ATRIAL FLUTTER AND WAS CARDIOVERTED TO SINUS TACHYCARDIA. THE PATIENT WAS PLACED ON INTRAVENOUS (IV) AMIODARONE FOR PREVENTATIVE CARE UNTIL ON (B)(6) 2024, WHEN HE WAS CLEARED AND PUT ON ORAL AMIODARONE FOR PROPHYLAXIS. ATRIAL FLUTTER WAS DETERMINED TO HAVE A PROBABLE RELATIONSHIP TO THE IMPELLA DEVICE. THE EVENT IS CONSIDERED RECOVERED WITH NO SEQUELAE. ON (B)(6) 2024, THE INTRA-AORTIC BALLOON PUMP (IABP) WAS REMOVED. THE PATIENT HAD A COLD RIGHT LOWER EXTREMITY ON EXAM ON (B)(6) 2024. THERE WERE SLIGHTLY IMPROVED DOPPLER PULSES ON (B)(6) 2024 BUT ON (B)(6) 2024, AN ANGIOGRAM SHOWED BLOOD CLOT IN THE SUPERFICIAL FEMORAL ARTERY. ASPIRIN AND PLAVIX WERE GIVEN. A THROMBECTOMY WAS SCHEDULED, BUT THE PATIENT EXPIRED BEFORE THE PROCEDURE COULD BE PERFORMED. RIGHT LOWER EXTREMITY ISCHEMIA WAS DETERMINED TO HAVE A PROBABLE RELATIONSHIP TO THE IMPELLA DEVICE. THE EVENT IS CON

  Patient problems: Arrhythmia; Ischemia; Renal Failure; Respiratory Failure; Tachycardia; Thromboembolism

  MAUDE report 25380395 ↗
• InjuryMay 19, 2026Patient Device Interaction Problem

  AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT A 77 YEAR OLD FEMALE WITH A KNOWN CARDIAC HISTORY. SHE WAS KNOWN TO BE A HEAVY TOBACCO SMOKER, HAVE HYPERLIPIDEMIA, CARDIOGENIC SHOCK, AND CORONARY ARTERY DISEASE. SHE WAS TRANSFERRED TO THE TERTIARY MEDICAL CENTER FOR CARE. SHE PRESENTED IN SCAI STAGE D SHOCK AT ADMISSION. THE CP WAS PLACED AND ALLOWED FOR THE TREATMENT OF THE ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK. THE PUMP PROVIDED SUPPORT FOR THE ANGIOPLASTY AND WAS EXPLANTED. AFTERWARDS IN THE HOSPITAL STAY SHE WAS FOUND TO HAVE SIGNS OF A STROKE/CVA. THERE WAS ARM WEAKNESS THAT PROMPTED IMAGING AND DIAGNOSIS MADE OF AN ACUTE INFARCT WITH CEREBRAL OCCLUSION. THE TEAM PERFORMED THROMBECTOMY AND MEDICALLY MANAGED WITH VASOPRESSIN AND LEVOPHED. SHE WAS FOLLOWED BY NEUROLOGY AND WAS NOTED TO BE STABLE. THE HARM POST EXPLANT WAS THOUGHT TO HAVE A POSSIBLE RELATIONSHIP TO THE USE OF THE IMPELLA, BUT TO DATE NO IMAGING OR OTHER CLINICAL DETAILS HAVE BEEN SHARED. THE HARM AND INTERVENTION WILL BE CONSERVATIVELY REPORTED.

  Patient problems: Low Blood Pressure/ Hypotension; Stroke/CVA

  MAUDE report 25217132 ↗
• DeathMay 18, 2026Patient Device Interaction Problem

  AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 59-YEAR-OLD MALE PATIENT FOR THE INDICATION OF ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK, PRESENTING IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE C SHOCK. FOLLOWING IMPELLA CP PLACEMENT, THE PATIENT DEVELOPED LOSS OF DISTAL PULSE IN THE RIGHT LOWER EXTREMITY (RIGHT PEDAL PULSE), AND THE RIGHT LEG WAS NOTED TO BE COOL TO TOUCH, CONSISTENT WITH LIMB ISCHEMIA. THE ISCHEMIA WAS REPORTED TO HAVE BEGUN DURING OR AFTER INSERTION OF THE REPOSITIONING UNIT. AT THE TIME OF THE EVENT, THE PATIENT WAS RECEIVING NOREPINEPHRINE (LEVOPHED), REFLECTING ONGOING HEMODYNAMIC SUPPORT REQUIREMENTS. AT THE TIME OF REPORTING, NO INTERVENTIONS HAD BEEN PERFORMED FOR THE LIMB ISCHEMIA AND NO ADDITIONAL INFORMATION WAS AVAILABLE REGARDING FURTHER MANAGEMENT. THE PATIENT WAS ESCALATED TO IMPELLA 5.5 SUPPORT FOR ONGOING HEMODYNAMIC INSTABILITY. THE REPORTED LIMB ISCHEMIA IS CONSISTENT WITH KNOWN RISKS ASSOCIATED WITH LARGE-BORE FEMORAL ARTERIAL ACCESS AND THE USE OF MECHANICAL CIRCULATORY SUPPORT IN CRITICALLY ILL PATIENTS REQUIRING VASOPRESSOR THERAPY, WHICH MAY CONTRIBUTE TO REDUCED DISTAL PERF

  Patient problems: Ischemia

  MAUDE report 25201812 ↗
• InjuryMay 11, 2026Restricted Flow rate; Malposition of Device; Patient Device Interaction Problem

  AN IMPELLA CP DEVICE WAS INSERTED INTO THE RIGHT FEMORAL ARTERY IN A 70-YEAR-OLD MALE PATIENT PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN SCAI STAGE D SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT FOR A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), HEMOLYSIS WAS NOTED BY RED/PINK URINE AND HEMOLYZED LABS. PLASMA FREE HEMOGLOBIN WAS 200. THE HEMOGLOBIN AND HEMATOCRIT (H/H) WERE STABLE AT 13.2 AND 39.6. POSITION VERIFIED AS SUBOPTIMAL, BUT UNABLE TO CORRECT. LATER IN THE DAY, THERE WAS ONGOING SUCTION. FLOW DROPPED DOWN TO P-2, BUT SUCTION CONTINUED. PLAN TO ESCALATE TO 5.5. SUCTION ALARMS DISABLED. AFTER 15 HOURS OF SUPPORT, THE DEVICE WAS REMOVED WITH AN ESCALATION OF THERAPY TO AN IMPELLA 5.5. THE IMPELLA FUNCTIONED AT P-5 AT 3.5L/MIN AS INTENDED. HEMOLYSIS MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS CRITICAL ILLNESS, UNDERLYING CARDIAC DYSFUNCTION, HEMODYNAMIC INSTABILITY, AND POTENTIAL DEVICE POSITION.

  Patient problems: Hemolysis

  MAUDE report 25136913 ↗
• InjuryMay 8, 2026Patient Device Interaction Problem

  CLINCIAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT AN 82 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH KNOWN CORONARY ARTERY DISEASE AND PLAN FOR A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). THE PATIENT'S UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE CP WAS INSERTED BUT, THE TEAM DID NOT USE ULTRASOUND GUIDANCE TO ACCESS WITH MICROPUNCTURE TECHNIQUE. THE SITE DEVELOPED A HEMATOMA. THIS BLEED REQUIRED INTERVENTION TO TREAT. THEY FOUND THE NEED TO APPLY MANUAL PRESSURE AND THEN CLOSE THE SITE WITH TWO STENTS AFTER OCCLUSIVE THROMBUS WAS OBSERVED AT THE FEMORAL SITE. THE FEMORAL SITE WAS NOT THE ONLY BLEED LOCATION. THE TEAM USED MANUAL PRESSURE AND TEGADERM TO ALSO RESOLVE THE RADIAL LINES BLEEDING. THESE MEASURES RESOLVED THE SMALL HEMATOMAS. THE PATIENT SURVIVED BOTH THE PCI AND INTERVENTIONS FOR THE BLEEDING. OF NOTE, ANTICOAGULATION NECESSARY FOR THE PUMP PLACEMENT AND SUPPORT CAN CONTRIBUTE TO ACCESS SITE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ischemia; Thromboembolism

  MAUDE report 25126092 ↗
• InjuryMay 7, 2026Patient Device Interaction Problem

  A 48-YEAR-OLD MALE WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRE-SUPPORT CLINICAL CONDITION CONSISTENT WITH SCAI SHOCK STAGE D, WAS SUPPORTED WITH AN IMPELLA CP DEVICE IMPLANTED PERCUTANEOUSLY VIA THE LEFT FEMORAL ARTERY ON (B)(6) 2026 AT 12:27 PM. DURING IMPELLA SUPPORT, HEMOLYSIS WAS SUSPECTED WHEN THE PATIENT VOIDED DARK RED/TINGED URINE AT FIRST URINATION; NO FOLEY CATHETER WAS IN PLACE. NO LABORATORY STUDIES WERE OBTAINED TO CONFIRM HEMOLYSIS. IMAGING WAS AVAILABLE AND USED TO CONFIRM GOOD PUMP POSITION, AND THERE WERE NO DOCUMENTED ANATOMIC ABNORMALITIES OF THE HEART OR EVIDENCE OF PUMP CONTACT WITH THE MITRAL VALVE APPARATUS. HIGH AFTERLOAD WAS IDENTIFIED AS A CONTRIBUTING FACTOR, AND CLINICAL MANAGEMENT INCLUDED REDUCTION OF AFTERLOAD AND DECREASING PUMP SPEED TO P6. IT WAS UNCLEAR WHETHER THE SUSPECTED HEMOLYSIS RESOLVED WITH THESE INTERVENTIONS; HOWEVER, THE CLINICAL TEAM ELECTED TO EXPLANT THE IMPELLA ON (B)(6) 2026 AT 9:03 AM, AS IT WAS BELIEVED THE DEVICE HAD PROVIDED THE NECESSARY OVERNIGHT SUPPORT. BASED ON THE AVAILABLE INFORMATION, THE PATIENT EXPERIENCED SUSPECTED HEMOLYSIS, IDENTIFIED BY DARK/TINGED URINE DURING IMPELLA CP SUPPORT, WHICH RESOLVED FO

  Patient problems: Hemolysis

  MAUDE report 25112049 ↗
• InjuryMay 6, 2026Difficult to Insert; Patient Device Interaction Problem

  CLINICAL NARRATIVE: A 40-YEAR-OLD MALE WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK WAS SUPPORTED WITH AN IMPELLA CP (SN (B)(6)) IMPLANTED PERCUTANEOUSLY VIA THE RIGHT FEMORAL ARTERY ON (B)(6) 2026 AT 16:00. DURING SUPPORT, THE PATIENT EXPERIENCED A DROP IN HEMOGLOBIN TO 6.4 G/DL ON THE NIGHT PRIOR TO EXPLANT, FOR WHICH ONE UNIT OF PACKED RED BLOOD CELLS WAS ADMINISTERED. THE PATIENT WAS SUCCESSFULLY WEANED FROM MECHANICAL CIRCULATORY SUPPORT. FOLLOWING REMOVAL OF THE IMPELLA CP, ANGIOGRAPHY OF THE RIGHT COMMON FEMORAL ARTERY DEMONSTRATED THE IMPELLA ACCESS SITE WAS LOCATED ABOVE AN ANATOMICALLY LOW EPIGASTRIC ARTERY. DUE TO CONCERN FOR POTENTIAL BLEEDING AND POSTERIOR HEMATOMA, CONTRALATERAL ACCESS WAS OBTAINED, THE PERCLOSE SUTURES WERE TIGHTENED, AND A 6F ANGIO-SEAL CLOSURE DEVICE WAS DEPLOYED. FINAL ANGIOGRAPHY FROM THE CONTRALATERAL ACCESS SITE WAS UNREMARKABLE WITH NO EVIDENCE OF ACTIVE BLEEDING. BASED ON THE AVAILABLE INFORMATION, THIS COMPLAINT INVOLVES A REPORT OF ANEMIA REQUIRING TRANSFUSION IN A PATIENT SUPPORTED WITH AN IMPELLA CP FOR AMI WITH CARDIOGENIC SHOCK, WITH THE PATIENT INJURY ATTRIBUTED TO IMPELLA PER REPORTER ASSESSMENT. REVIEW OF THE INF

  Patient problems: Anemia

  MAUDE report 25095336 ↗
• InjuryMay 6, 2026Patient Device Interaction Problem

  CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED INTO THE RIGHT FEMORAL ARTERY IN A 67-YEAR-OLD MALE PATIENT PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT FOR A BAILOUT OF A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THERE WAS RED TINGED URINE UPON FOLEY INSERTION. LABS ORDERED AND GOOD PUMP POSITIONED VERIFIED UNDER ECHOCARDIOGRAM. AFTER ONE DAY ON SUPPORT, THE DEVICE WAS REMOVED WITH AN ESCALATION OF THERAPY TO AN IMPELLA 5.5. THE POST-PROCEDURE OUTCOME IS SURVIVED AT EXPLANT. THE IMPELLA FUNCTIONED AT P-9 AT 3.5L/MIN AS INTENDED. BLEEDING (HEMATURIA) IS A KNOWN RISK DUE TO THE IMPELLA'S ANTICOAGULATION AND PURGE REQUIREMENTS.

  Patient problems: Hematuria

  MAUDE report 25092448 ↗
• InjuryMay 5, 2026Patient Device Interaction Problem

  AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE MALE PATIENT OF UNKNOWN AGE WHO HAD BEEN ADMITTED IN WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE D SHOCK. THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED. ON THE DAY OF IMPLANT AND AFTER THE FLIGHT TRANSFER THERE WAS A HEMATOMA OBSERVED AT THE GROIN ACCESS SITE. THE INJURY WAS OF VASCULAR DAMAGE BUT, THE INTERVENTION, IF ANY, HAS NOT YET BEEN SHARED. NO BLOOD PRODUCTS HAVE YET BEEN GIVEN. ANTICOAGULATION NECESSARY FOR THE PUMP PLACEMENT AND SUPPORT CAN CONTRIBUTE TO ACCESS SITE BLEEDING. AFTER 2 DAYS OF SUPPORT THE PUMP WAS WEANED AND EXPLANTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 25084112 ↗
• InjuryMay 5, 2026Patient Device Interaction Problem

  AN IMPELLA CP DEVICE WAS INSERTED INTO THE LEFT FEMORAL ARTERY IN A 58-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF A PRIOR CORONARY ARTERY BYPASS GRAFT (CABG) AND CORONARY ARTERY DISEASE (CAD), PRESENTING IN POST-CARDIOTOMY CARDIOGENIC SHOCK (PCCS) AND LOW CARDIAC OUTPUT SYNDROME (LCOS), IN SCAI STAGE D SHOCK, ON AN INTRA-AORTIC BALLOON PUMP (IABP), ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT DURING A CARDIOTHORACIC (CT) SURGERY: CABG. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THERE WAS A HEMATOMA AT THE ACCESS SITE. IN ADDITION, THERE WAS SUSPECTED HEMOLYSIS DUE TO AN ELEVATED LACTASE DEHYDROGENASE (LDH), REQUIRING BLOOD PRODUCTS. THE PUMP WAS NOTED TO BE IN GOOD POSITION. IT WAS NOTED THAT THE PATIENT ALSO HAD SHOCK LIVER. THE HEMOGLOBIN DROPPED FROM 9 TO 6.8 IN AN 8 HOUR PERIOD. CHEST TUBE OUTPUT WAS ABOUT 150MLS. NO TYPE OF BLEEDING WAS OBSERVED. AFTER ONE DAY ON SUPPORT, THE DEVICE WAS SUCCESSFULLY WEANED. THE POST-PROCEDURE OUTCOME IS SURVIVED AT EXPLANT. THE IMPELLA FUNCTIONED AT P-2 AT

  Patient problems: Hematoma; Hemolysis

  MAUDE report 25083662 ↗
• InjuryApr 30, 2026Patient Device Interaction Problem

  CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED TO SUPPORT THE 83 YEAR OLD FEMALE CARDIAC PATIENT, WITH MEDICAL HISTORY NOT SHARED. THE PUMP WAS EXPLANTED A DAY AFTER THE SUPPORT WAS PLACED DUE TO CONCERNS OF HEMOLYSIS. THE PATIENT'S PLASMA FREE HEMOGLOBIN LEVEL HAD RISEN FROM 1.7MG/DL TO 95.3MG/DL. THE PATIENT HAD THE PUMP EXPLANTED AND REPLACED BY AN INTRA-AORTIC BALLOON PUMP. THE PATIENT SURVIVED THE HEMOLYSIS. HEMOLYSIS MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS CRITICAL ILLNESS, UNDERLYING CARDIAC DYSFUNCTION, HEMODYNAMIC INSTABILITY, RENAL FUNCTION, ANTICOAGULATION STATUS, AND POTENTIAL DEVICE POSITION

  Patient problems: Hemolysis

  MAUDE report 25045790 ↗
• InjuryApr 23, 2026Increase in Pressure; Deformation Due to Compressive Stress; Device Sensing Problem; Patient Device Interaction Problem

  CLINICAL NARRATIVE: A 77-YEAR-OLD MALE WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK (PRE-SUPPORT CLINICAL STATE CONSISTENT WITH SCAI SHOCK STAGE D) WAS SUPPORTED WITH AN IMPELLA CP INSERTED PERCUTANEOUSLY VIA THE RIGHT FEMORAL ARTERY ON (B)(6) 2026 AT 10:48 AM. DURING SUPPORT, A DISCREPANCY WAS NOTED WITH THE AORTIC PLACEMENT SIGNAL READING APPROXIMATELY 20¿30 MMHG BELOW THE CONCURRENTLY MEASURED ARTERIAL LINE PRESSURE. THE BEDSIDE NURSE REPORTED A SUDDEN CHANGE IN DEVICE PERFORMANCE CHARACTERIZED BY A DECREASE IN PUMP FLOW TO APPROXIMATELY 3 ML/HR AND AN INCREASE IN PURGE PRESSURE TO GREATER THAN 800 MMHG. THE BEDSIDE NURSE REPORTED A SUDDEN CHANGE IN DEVICE PERFORMANCE CHARACTERIZED BY A DECREASE IN PUMP FLOW TO APPROXIMATELY 3 ML/HR AND AN INCREASE IN PURGE PRESSURE TO GREATER THAN 800 MMHG. LINE TRACING IDENTIFIED THE PURGE TUBING WRAPPED AROUND THE PATIENT¿S FOOT, AND THE TUBING WAS SUBSEQUENTLY FREED; HOWEVER, AFTER APPROXIMATELY 15 MINUTES, THERE WAS MINIMAL IMPROVEMENT IN PURGE PRESSURE OR PUMP FLOW. CONCURRENTLY, THE LOCAL CLINICAL TEAM REPORTED LABORATORY FINDINGS CONCERNING FOR HEMOLYSIS, INCLUDING ACUTE ANURIA, ELEVATED LDH, RISING CREATININE, AND INCREASED TO

  Patient problems: Hemolysis

  MAUDE report 24967249 ↗
• DeathApr 20, 2026Device Sensing Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 55 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH CARDIOMYOPATHY, PRESENTING IN SCAI STAGE E SHOCK. PRIOR TO THE PUMP PLACEMENT THE PATIENT WAS SUPPORTED BY INOTROPES, VASOPRESSORS, AND A VENT FOR RESPIRATORY NEEDS. THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED. AFTER THE CP WAS INSERTED THE PATIENT WAS BROUGHT TO THE ICU FOR CONTINUED MONITORING AND UPON ADMIT TO THE ICU THE TEAM OBSERVED TINGED URINE. THEY HAD JUST PLACED THE FOLEY CATHETER. THE TEAM PERFORMED ECHO IMAGING TO OBSERVE THE PUMP POSITION AND THE TEAM SENT BLOOD FOR THE PLASMA FREE HEMOGLOBIN TO DETERMINE IF THE PATIENT WAS SUFFERING FROM HEMOLYSIS OR A TRAUMATIC FOLEY INSERTION. THE LABS CONFIRMED A DIAGNOSIS OF HEMOLYSIS. THE PUMP REMAINS ON FOR SUPPORT TO DATE AND TROUBLESHOOTING FOR THE HEMOLYSIS HAS BEEN THE LOWERING OF THE PUMP P LEVEL AND REPOSITIONING THE PUMP. HEMOLYSIS MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS CRITICAL ILLNESS, UNDERLYING CARDIAC DYSFUNCTION, HEMODYNAMIC INSTABILITY, RENAL FUNCTION, ANTICOAGULATION STATUS, AND POTENTIAL DEVICE POSITION.

  Patient problems: Hematuria; Hemolysis

  MAUDE report 24924590 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 69-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), WITH A HISTORY OF KNOWN CORONARY ARTERY DISEASE, DIABETES MELLITUS, AND RENAL INSUFFICIENCY. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE¿D. DURING SUPPORT, THE NURSE REPORTED HEMATURIA. THE IMPELLA WAS WEANED FROM P8 TO P4, WITH NO FURTHER INTERVENTION. THERE WAS SOME IMPROVEMENT IN THE HEMATURIA. THE PATIENT SURVIVED TO EXPLANT. THE HEMATURIA MAY BE DUE TO PURGE-RELATED ANTICOAGULATION REQUIREMENTS AND MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS UNDERLYING CARDIOGENIC SHOCK, HEMODYNAMIC INSTABILITY AND RENAL DYSFUNCTION.

  Patient problems: Hematuria

  MAUDE report 24880186 ↗
• InjuryApr 13, 2026Malposition of Device

  AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 55-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS). THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE E. DURING SUPPORT, THE PATIENT DEVELOPED PINK-COLORED URINE. THE IMPELLA WAS REPOSITIONED UNDER ECHOCARDIOGRAPHIC GUIDANCE. OTHER CONTRIBUTING FACTORS INCLUDED A HIGH-PERFORMANCE LEVEL (P-LEVEL), A HYPERDYNAMIC LEFT VENTRICLE, AND INITIALLY SHALLOW DEVICE PLACEMENT. THE PATIENT SURVIVED TO EXPLANT. THE HEMATURIA MAY OCCUR IN THE SETTING OF PURGE-RELATED ANTICOAGULATION REQUIREMENTS AND MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS UNDERLYING CARDIOGENIC SHOCK, HEMODYNAMIC INSTABILITY, HYPERDYNAMIC VENTRICULAR FUNCTION AND DEVICE POSITION.

  Patient problems: Hematuria

  MAUDE report 24859703 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  AN 87 YEAR OLD MALE UNDERWENT A HIGH RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI) WITH IMPELLA CP SUPPORT IMPLANTED PERCUTANEOUSLY VIA THE RIGHT FEMORAL ARTERY ON (B)(6) 2026 AT 11:10 AM. THE PATIENT¿S PRE SUPPORT CLINICAL CONDITION WAS CONSISTENT WITH SCAI SHOCK STAGE A. DURING THE PROCEDURE, THE PHYSICIAN NOTED A DISSECTION OF THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY; HOWEVER, THE PHYSICIAN DOCUMENTED THAT THE DISSECTION WAS NOT ATTRIBUTED TO THE IMPELLA DEVICE. THE IMPELLA CP WAS ELECTIVELY EXPLANTED ON (B)(6) 2026 AT 1:20 PM FOLLOWING COMPLETION OF THE PROCEDURE. THE PATIENT SURVIVED THE PROCEDURE, WAS SUCCESSFULLY WEANED FROM IMPELLA SUPPORT, AND NO PATIENT INJURY WAS ATTRIBUTED TO THE DEVICE. THERE WERE NO DEVICE MALFUNCTIONS REPORTED, NO ALARMS OR ABNORMAL DEVICE PERFORMANCE DESCRIBED, AND NO OTHER CONTRIBUTING FACTORS IDENTIFIED. NO PRODUCT WAS RETURNED, AS THE DEVICE WAS DISCARDED PER HOSPITAL PROTOCOL, AND NO DEVICE DATA DOWNLOAD WAS REQUIRED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT REPRESENTS NO DEVICE INVOLVEMENT, AND THE REPORTED LAD DISSECTION WAS DETERMINED BY THE PHYSICIAN TO BE UNRELATED TO THE IMPELLA CP DEVICE. NO CORRECTIVE ACTION OR FURTH

  Patient problems: Aortic dissection

  MAUDE report 24858008 ↗
• DeathApr 9, 2026Adverse Event Without Identified Device or Use Problem

  AN 85-YEAR-OLD MALE WITH A HISTORY OF ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK, CONSISTENT WITH SCAI SHOCK STAGE D, UNDERWENT PERCUTANEOUS RIGHT FEMORAL ARTERIAL PLACEMENT OF AN IMPELLA CP (584927) DEVICE ON (B)(6) 2026 AT 16:20. ANTICOAGULATION THERAPY WITH HEPARIN AT 10 UNITS/KG/HR WAS ADMINISTERED, WITH ACT USED FOR ANTICOAGULATION MONITORING. FOLLOWING TRANSFER FROM THE CARDIAC CATHETERIZATION LABORATORY TO THE INTENSIVE CARE UNIT, THE PATIENT WAS NOTED TO BE UNSEDATED WITH SIGNIFICANT LOWER EXTREMITY MOVEMENT, DESCRIBED AS KICKING LEGS WILDLY. DURING AN ICU NURSING ASSESSMENT, ACTIVE BLEEDING WAS OBSERVED AT THE FEMORAL ACCESS SITE AROUND THE INTRODUCER SHEATH, WITH A SMALL HEMATOMA NOTED. NO ACT VALUE AT THE TIME OF BLEEDING WAS AVAILABLE. THE HEPARIN INFUSION WAS PROMPTLY DISCONTINUED, AND HEMOSTASIS WAS ACHIEVED USING A FEMSTOP DEVICE, WITH ADJUNCT USE OF 4X4 GAUZE. FORWARD SUTURING HAD BEEN UTILIZED, AND THE REPOSHEATH WAS CONFIRMED TO BE PROPERLY PLACED WITH APPROPRIATE ANGLE MATCHING. BASED ON AVAILABLE INFORMATION, THE REPORTED EVENT INVOLVED ACCESS SITE BLEEDING FOLLOWING ICU TRANSFER, TEMPORALLY ASSOCIATED WITH SIGNIFICANT PATIENT MOVEMENT WHILE ON

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24835674 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ACCESS SITE TO SUPPORT A 81 YEAR OLD FEMALE PATIENT WHO HAD BEEN ADMITTED IN WITH KNOWN CORONARY ARTERY DISEASE AND A PLAN FOR A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE CP ALLOWED FOR THE PCI BUT, DUE TO AN ACCESS SITE BLEED AROUND THE SHEATH, THE TEAM MADE DECISION TO EXPLANT THE PUMP. THE PATIENT WAS NOTED TO BE HEMODYNAMICALLY STABLE POST EXPLANT. OF NOTE THE PATIENT WAS ON BOTH ANTICOAGULANTS AND ANTIPLATELETS. ANTICOAGULATION NECESSARY FOR THE PUMP PLACEMENT AND SUPPORT CAN CONTRIBUTE TO ACCESS SITE BLEEDING. THE PATIENT HAS SURVIVED THE HARM.

  Patient problems: Hematoma

  MAUDE report 24799714 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140003. One submission often covers many models, so check the product and lot details in each record.

• Z-3148-2026 · Aug 12, 2026 · Open, Classified
  Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella
• Z-3150-2026 · Aug 12, 2026 · Open, Classified
  Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Conn
• Z-3149-2026 · Aug 12, 2026 · Open, Classified
  Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella
• Z-2457-2026 · May 18, 2026 · Open, Classified
  Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
• Z-2360-2026 · May 14, 2026 · Open, Classified
  Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; P
• Z-2211-2026 · Apr 20, 2026 · Open, Classified
  Automated Impella Controller (AIC); Product Code: 0042-0000-US;
• Z-1589-2026 · Feb 18, 2026 · Open, Classified
  Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5
• Z-1591-2026 · Feb 16, 2026 · Open, Classified
  Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Contr
• Z-1030-2026 · Dec 4, 2025 · Open, Classified
  Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.
• Z-0069-2026 · Oct 1, 2025 · Open, Classified
  Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product
• Z-0136-2026 · Sep 16, 2025 · Open, Classified
  Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella
• Z-2164-2025 · Jun 23, 2025 · Open, Classified
  Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella
• Z-2319-2024 · May 31, 2024 · Open, Classified
  Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
• Z-0636-2024 · Dec 6, 2023 · Open, Classified
  Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
• Z-0440-2024 · Oct 10, 2023 · Terminated
  Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.

…and 6 more.