Introducer Kit for Impella® 0052-3006 (UDI 00813502011609)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,184 adverse event reports that list this exact device (DI 00813502011609), received between Jun 15, 2018 and Sep 29, 2026 — classified as 223 deaths, 632 injuries, 329 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (61 reports).

4 FDA recall records name this device's identifier, 4 still open.

4 other recalls cover devices cleared under the same FDA submission (K122084); 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 18, 2026.

Recalls naming this device

1. Jun 11, 2026Class IOpen, 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-2690-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Aug 5, 2024Class IIOpen, 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-2955-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Dec 27, 2023Class IIOpen, 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, 2023Class IOpen, 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,184 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Failure to Advance; Device Damaged by Another Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938430 ↗
• InjuryAug 26, 2026Restricted Flow rate

  An Impella CP was inserted via the left femoral artery in a 56-year-old male patient undergoing planned coronary artery bypass surgery. The patient's comorbidity was known coronary artery disease. The SCAI shock stage prior to support initiation was not documented. Prior to Impella support, the patient was receiving respiratory support.Two days after implantation, the patient's condition deteriorated with concerns for right heart failure. Extracorporeal membrane oxygenation (ECMO) was initiated as the primary support modality, and inotropic and vasopressor therapy were added. The Impella CP remained in place to provide left ventricular unloading and venting during ECMO support.On day 3 of support, the Impella CP experienced a sudden reduction in flow associated with suction alarms. Troubleshooting measures included reduction of the pump performance level, assessment of device position, and evaluation of volume status, all of which were reported to be appropriate. Due to the low-flow event and ongoing need for escalated circulatory support, the decision was made to explant the Impella CP and upgrade support to an Impella 5.5 device.At the time of explant, clot material was observed

  Patient problems: Thromboembolism

  MAUDE report 50457368 ↗
• InjuryAug 26, 2026Difficult to Remove

  An Impella CP was implanted via the right femoral artery in a 70-year-old male patient for pre-operative ventricular support prior to a planned ventricular septal perforation (VSP) closure. Prior to Impella support, the patient was classified as Society for Cardiovascular Angiography and Intervention (SCAI) Stage B shock, indicating hemodynamic instability. The patient was receiving ventilatory support prior to implantation. The patient's past medical history was not reported.The Impella CP provided hemodynamic support and functioned within expected operating parameters at P-5 with reported flows of approximately 2.6 L/min utilizing a D5W Sodium Bicarbonate purge solution.After approximately four days of support, an attempt was made to surgically remove the Impella CP in the intensive care unit (ICU); however, significant resistance was encountered during extraction. Fluoroscopic evaluation demonstrated that the pigtail tip remained stationary, raising concern for entanglement with an intracardiac structure. The patient was transferred to a hybrid operating room, where a second removal attempt under fluoroscopic guidance was performed; however, the device remained unable to be extr

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50456035 ↗
• InjuryAug 3, 2026Patient Device Interaction Problem

  Clinical Narrative Impella CP was inserted via left femoral artery in a 80-year-old male patient presenting with Acute Myocardial Infarction and Cardiogenic Shock. The patient¿s comorbidities were known peripheral arterial disease at the superficial femoral artery. The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage E. Prior to the Impella CP placement the patient was supported by Extra Corporeal Membrane Oxygenation (ECMO).While on support the the device functioned as expected, Performance Level P-8 with 3.1L/min flow with 5% Dextrose in water with sodium bicarbonate in the purge solution.While on support the team did add inotropes and vasopressors due to patient condition. The Impella accessed limb showed signs of ischemia. The leg had become pale and discolored. This prompted the explant of the pump after just 1 day of support. The Physician placed a new second Impella CP at the right subclavian artery and performed endovascular thrombectomy (EVT) to restore limb flow.The patient's limb ischemia occurred after the pump delivery to the femoral artery which was noted to be narrow. The underlyin

  Patient problems: Ischemia

  MAUDE report 50122855 ↗
• InjuryAug 3, 2026Malposition of Device; Patient Device Interaction Problem

  US Updated clinical narrative: Additional information provided on 31JUL2026 The device was explanted on (b)(6)2026Prior US Clinical Narrative:Impella CP was percutaneously inserted via left femoral artery access site in a 77-year-old male patient presenting with cardiomyopathy and suspected myocarditis. The patient¿s comorbidities were not reported. The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage D. The patient was medically supported by inotropes, vasopressors and was concurrently on ECMO.During Impella support, there were concerns of hemolysis identified by hematuria. Imaging was utilized to assess pump position, and improper device positioning was initially suspected; however, despite position adjustment, hemolysis persisted without immediate improvement. No anatomical cardiac abnormalities were reported, and there was no reported contact between the pump and mitral valve structures. Haptoglobin therapy was administered, and following ECMO weaning and reduction of Impella support level from Performance (P) level P-7 to P-4, the hemolysis showed signs of improvement.The hemolysis was most

  Patient problems: Hemolysis

  MAUDE report 50114548 ↗
• InjuryJul 27, 2026Restricted Flow rate; Increase in Pressure; Deformation Due to Compressive Stress

  Clinical Narrative:An Impella CP device was inserted into the right femoral artery in a 56-year-old male patient presenting in acute myocardial infarction (AMI) and cardiogenic shock (CGS), prior to initiation of support. The patient's comorbidities and Society for Cardiovascular Angiography & Intervention (SCAI) shock stage are unknown.While the patient was in the intensive care unit (ICU), the right leg was immobilized with a knee extension brace to prevent flexion of the groin and knee. On the eighth day of support, it was noted that the purge sidearm was completely separated, cutting off the supply of purge fluid. due to the patient bending the knee. The Impella was removed and replaced with an intra-aortic balloon pump (IABP).The post-procedure outcome is survived at explant. While on support, the Impella functioned as intended at performance level P-4 at 2.2L/min with D5W Heparin in the purge solution.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50034399 ↗
• MalfunctionMay 6, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT IMPLANTATION OF AN IMPELLA CP WAS ABORTED DUE TO PATIENT ANATOMY. THE PUMP COULD NOT ADVANCE PAST THE PATIENT'S TORTUOUS AORTIC ARCH. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096399 ↗
• InjuryApr 3, 2026Use of Device Problem; Malposition of Device

  CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE FEMORAL ARTERY IN A 75-YEAR-OLD PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), SCAI SHOCK STAGE E. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. AFTER IMPELLA CP INSERTION, AN ALARM INDICATING THAT THE PUMP POSITION WAS WITHIN THE AORTA OCCURRED WHILE THE PATIENT WAS BEING REPOSITIONED IN BED FOR TRANSPORT BACK TO THE ROOM. FLUOROSCOPIC IMAGING CONFIRMED THAT THE DEVICE HAD BEEN PULLED INTO THE AORTA. A DRYSEAL SHEATH WAS IN USE, AND THE VALVE WAS CONFIRMED TO BE CLOSED. THE FIXATION WINGS WERE CHECKED FOR TENSION. IT WAS BELIEVED THAT A LOOSE FIXING RING, DUE TO INSUFFICIENT VERIFICATION OF SECUREMENT, ALLOWED TENSION TO BE TRANSMITTED DURING MOVEMENT, RESULTING IN DEVICE MIGRATION. THE PATIENT WAS SUBSEQUENTLY MANAGED WITH ECMO AND AN INTRA-AORTIC BALLOON PUMP (IABP), AND THE IMPELLA¿CP DEVICE WAS REMOVED. THE REPORTED EVENTS ARE DEVICE IN THE WRONG POSITION, USE AGAINST LABELING, MEDICAL DEVICE REMOVAL, AND HEMODYNAMIC INSTABILITY. THE DEVICE WILL BE CONSERVATIVELY REPORTED FOR SERIOUS INJURY DUE TO TEMPORARY HEMODYNAMIC SUPPORT INTERRUPTION DURING DEVICE REMOVAL; HOWEVER,

  Patient problems: Hemodynamic instability

  MAUDE report 24780719 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  A 12 YEAR OLD FEMALE PATIENT WITH A HISTORY OF CARDIOMYOPATHY AND A PRE SUPPORT CLINICAL STATUS CONSISTENT WITH SCAI SHOCK STAGE C WAS HOSPITALIZED ON (B)(6) 2024 WITH CIRCULATORY FAILURE SECONDARY TO ACUTE MYOCARDITIS. ON HOSPITAL DAY 9, THE PATIENT DEVELOPED LOW GRADE FEVER (37°C). MULTIPLE CULTURES WERE OBTAINED AND WERE UNREMARKABLE, AND EMPIRIC ANTIBIOTIC THERAPY DID NOT RESULT IN CLINICAL IMPROVEMENT. VA ECMO AND TRANSVENOUS PACING WERE DISCONTINUED ON HOSPITAL DAY 10. WHILE THE PATIENT¿S BODY TEMPERATURE WAS INITIALLY CONTROLLED THROUGH CHD CIRCUIT TEMPERATURE MANAGEMENT, DISCONTINUATION OF CHD ON HOSPITAL DAY 14 WAS FOLLOWED BY A RAPID TEMPERATURE INCREASE TO 40°C, ASSOCIATED WITH WORSENING CARDIAC FUNCTION. ANTIPYRETIC THERAPIES, INCLUDING ACETAMINOPHEN AND FLURBIPROFEN AXETIL, WERE INEFFECTIVE, AND CHD WAS RESUMED ON HOSPITAL DAY 15 FOR TEMPERATURE CONTROL. FOLLOWING EXPLANT OF THE IMPELLA CP ON (B)(6) 2024 AT 5:04 AM, THE PATIENT¿S FEVER PATTERN IMPROVED. BASED ON THE AVAILABLE INFORMATION, THIS COMPLAINT DOCUMENTS A FEBRILE EVENT OCCURRING DURING IMPELLA CP SUPPORT IN A PEDIATRIC PATIENT WITH ACUTE MYOCARDITIS AND MULTISYSTEM CRITICAL ILLNESS. EXTENSIVE INFECTIOUS WORKU

  Patient problems: Fever; Unspecified Infection

  MAUDE report 24764859 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  AN IMPELLA CP DEVICE WAS INSERTED VIA THE FEMORAL ARTERY IN A 50-YEAR-OLD MALE PATIENT PRESENTING WITH CARDIOMYOPATHY, SCAI SHOCK STAGE C. THE PATIENT'S COMORBIDITIES WERE NOT DOCUMENTED. ONE MONTH PRIOR TO ADMISSION, HE DEVELOPED EXERTIONAL DYSPNEA AND WAS INITIALLY TREATED WITH DIURETICS AT A LOCAL HOSPITAL FOR SUSPECTED HEART FAILURE; HOWEVER, HIS CONDITION DID NOT IMPROVE, PROMPTING REFERRAL TO THE REPORTING HOSPITAL. HE WAS DIAGNOSED WITH ACUTE HEART FAILURE ACCOMPANIED BY FLUID RETENTION AND ORGAN FAILURE. ON ADMISSION, BLOOD PRESSURE WAS 110/86 MMHG, HEART RATE 123 BEATS/MIN, AND OXYGEN SATURATION 99% ON ROOM AIR. ECHOCARDIOGRAPHY DEMONSTRATED A LEFT VENTRICULAR EJECTION FRACTION OF 15%, LEFT-VENTRICULAR END-DIASTOLIC DIAMETER OF 57 MM, SEPTAL WALL THICKNESS OF 8 MM, AND POSTERIOR WALL THICKNESS OF 9 MM. THERE WAS NO CLINICAL HISTORY SUGGESTIVE OF ACUTE CORONARY SYNDROME OR ACUTE MYOCARDITIS. DUE TO FINDINGS OF TISSUE HYPOPERFUSION, TREATMENT WITH INOTROPIC AGENTS AND LOW-DOSE DIURETICS WAS INITIATED. THAT SAME NIGHT, DELIRIUM PROGRESSED TO HEMODYNAMIC COLLAPSE, AND COMBINED SUPPORT WITH EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND IMPELLA (ECPELLA) WAS INITIATED. DURING E

  Patient problems: Embolism/Embolus; Thrombosis/Thrombus

  MAUDE report 24764831 ↗
• InjuryMar 20, 2026Patient Device Interaction Problem

  CLINICAL RATIONALE: A PATIENT WITH UNKNOWN DEMOGRAPHICS AND GENDER, TREATED FOR ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK (PRE SUPPORT SCAI STAGE C), WAS SUPPORTED WITH AN IMPELLA CP INSERTED VIA THE RIGHT FEMORAL ARTERY ON (B)(6) 2026. HEMOLYSIS WAS IDENTIFIED DURING CP SUPPORT, DIAGNOSED BY HEMATURIA. IMAGING CONFIRMED CORRECT IMPELLA CP POSITIONING, AND PUMP VOLUME WAS REPORTED AS ADEQUATE. DESPITE THIS, HEMOLYSIS PERSISTED AND CONTINUOUS DIALYSIS WAS REQUIRED FOR SEVERAL DAYS, THOUGH URINE OUTPUT WAS MAINTAINED. THE IMPELLA CP WAS NOT REMOVED DUE TO A DEVICE FAILURE MODE, AND NO ANATOMIC ABNORMALITIES, ORGAN DAMAGE, OR VALVE CONTACT WERE REPORTED. ON (B)(6) 2026, THE PATIENT WAS ESCALATED TO IMPELLA 5.5 SUPPORT DUE TO INSUFFICIENT HEMODYNAMIC SUPPORT FROM THE CP AND ANTICIPATED PROLONGED THERAPY. HEMOLYSIS ONSET TIMING IS UNKNOWN, AND THE RELATIONSHIP BETWEEN THE DEVICE AND PATIENT OUTCOME IS LISTED AS UNKNOWN. THE PATIENT SURVIVED THE CP EXPLANT ON (B)(6) 2026, AND THE IMPELLA 5.5 REMAINS IN PLACE. THE CP PUMP IS EXPECTED TO BE RETURNED FOR EVALUATION; DATA DOWNLOAD IS REQUIRED. AVAILABLE INFORMATION CONFIRMS THAT HEMOLYSIS OCCURRED WHILE THE IMPELLA CP WAS IN CORRECT

  Patient problems: Hemolysis; Renal Failure

  MAUDE report 24650272 ↗
• DeathMar 18, 2026Adverse Event Without Identified Device or Use Problem

  CLINICAL RATIONALE: AN IMPELLA CP DEVICE WAS INSERTED INTO THE FEMORAL ARTERY IN A 84-YEAR-OLD MALE PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) PRIOR TO SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT FOR A BAILOUT OF A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. ONE WEEK LATER, A RETROPERITONEAL HEMORRHAGE WAS DETECTED ON COMPUTED TOMOGRAPHY (CT) SCAN. THE PATIENT WENT TO INTERVENTIONAL RADIOLOGY, BUT THE CAUSE OF BLEEDING COULD NOT BE IDENTIFIED, LEADING TO PALLIATIVE CARE. THE ACTIVATED CLOTTING TIME (ACT) WAS 160-180. EIGHT DAYS AFTER IMPELLA INSERTION, THE PATIENT EXPIRED ON SUPPORT. THE IMPELLA FUNCTIONED AT P-5 AS INTENDED. BLEEDING IS A KNOWN RISK DUE TO THE IMPELLA'S ANTICOAGULATION AND PURGE REQUIREMENTS. THE IMPELLA IS CONSERVATIVELY BEING REPORTED FOR DEATH; HOWEVER, WAS ATTRIBUTED TO MULTI-ORGAN FAILURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24632263 ↗
• MalfunctionMar 18, 2026Failure to Advance

  THE COMPLAINANT REPORTED THAT A PATIENT WAS TO BE IMPLANTED WITH AN IMPELLA CP VIA PERCUTANEOUS FEMORAL ARTERY FOR MECHANICAL CIRCULATORY SUPPORT. DIFFICULTY INSERTING WAS NOTED. CALCIFICATION IN THE AORTIC ARCH PREVENTED THE INSERTION OF IMPELLA CP. CALCIFICATION IN THE LOWER EXTREMITIES CAN BE ASSESSED, BUT CALCIFICATION IN THE AORTIC ARCH CANNOT BE ASSESSED BEFOREHAND. NO HARM WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631784 ↗
• MalfunctionMar 17, 2026Device Damaged by Another Device; Device Sensing Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA CP EXPERIENCED A PLACEMENT SIGNAL NOT RELIABLE ALARM. THE ALARM WAS DISABLED AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615851 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  CLINICAL RATIONALE: A 75-YEAR-OLD MALE UNDERWENT IMPELLA CP (B)(6) PLACEMENT ON (B)(6) 2026 AT 14:30 FOR PRE OPERATIVE HEMODYNAMIC SUPPORT. THE DEVICE WAS INSERTED PERCUTANEOUSLY VIA THE FEMORAL ARTERY IN THE CATHETERIZATION LAB, AFTER WHICH THE PATIENT WAS IMMEDIATELY TAKEN TO THE OPERATING ROOM FOR CABG. APPROXIMATELY THREE HOURS AFTER IMPELLA PLACEMENT, AT 08:00 ON (B)(6) 2026, THE PATIENT DEVELOPED LOWER LIMB ISCHEMIA, CHARACTERIZED BY PERIPHERAL COLD SENSATION. THE ISCHEMIA WAS DIAGNOSED DURING/AFTER SHEATH INSERTION AND ATTRIBUTED TO IMPELLA USE, WITH THE PATIENT¿S VESSEL DIAMETER REPORTED AS <2.5/4 MM. THE IMPELLA CP WAS REMOVED AT 19:00 ON (B)(6) 2026, AND THE ISCHEMIA RESOLVED FOLLOWING DEVICE EXPLANT. DUE TO ONGOING CLINICAL NEEDS, AN IMPELLA 5.5 WAS SURGICALLY IMPLANTED VIA THE RIGHT AXILLARY/SUBCLAVIAN ARTERY ON (B)(6) 2026 AT 12:00 AM, PRODUCT RETURN IS NOT EXPECTED FOR THE IMPELLA CP, AND NO DEVICE DAMAGE WAS NOTED. THE PATIENT¿S OUTCOME IS PENDING AS HE IS CURRENTLY ON SUPPORT. THE IMPELLA CP WILL BE CONSERVATIVELY REPORTED FOR HEMODYNAMIC INSTABILITY DUE TO TEMPORARY HEMODYNAMIC SUPPORT INTERRUPTION DURING THE EXCHANGE HOWEVER THE EXCHANGE WAS PERFORMED WITH NO CONS

  Patient problems: Hemodynamic instability; Ischemia

  MAUDE report 24581028 ↗
• InjuryMar 5, 2026Failure to Advance

  AN IMPELLA CP DEVICE WAS INSERTED VIA THE FEMORAL ARTERY IN A 75-YEAR-OLD MALE PATIENT PRESENTING WITH POST-CARDIOTOMY CARDIOGENIC SHOCK/LOW CARDIAC OUTPUT SYNDROME (PCCS/LCOS), SCAI SHOCK STAGE C. THERE WAS INFORMATION THAT IMPELLA CP USE HAD BEEN CONSIDERED IN OTHER PCCS CASES INVOLVING BENTALL + CABG, BUT IN THIS PATIENT¿S CASE, INSERTION WAS NOT POSSIBLE. AFTER IMPELLA INSERTION WAS DISCONTINUED, NO FURTHER IMPELLA SUPPORT WAS PROVIDED, AND THE PATIENT WAS TRANSITIONED TO ECMO FOR CIRCULATORY SUPPORT.THE REPORTED EVENTS INCLUDE FAILURE TO ADVANCE, MEDICAL DEVICE REMOVAL, AND HEMODYNAMIC INSTABILITY. THE IMPELLA CP WILL BE CONSERVATIVELY REPORTED FOR SERIOUS INJURY DUE TO TEMPORARY HEMODYNAMIC SUPPORT INTERRUPTION DURING DEVICE REMOVAL; HOWEVER, THE REMOVAL WAS PERFORMED WITH NO CONSEQUENCE TO THE PATIENT, AND SUPPORT WAS RESUMED VIA ECMO WITHOUT ANY KNOWN ADVERSE EVENTS.

  Patient problems: Hemodynamic instability

  MAUDE report 24518399 ↗
• DeathFeb 26, 2026Malposition of Device

  CLINICAL RATIONALE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE FEMORAL ARTERY IN A PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS). THE IMPELLA CP WAS INITIALLY PLACED BUT SUBSEQUENTLY REMOVED DUE TO A POSITIONING ISSUE. A RE-ATTEMPT WAS MADE TO RE-PLACE THE DEVICE; HOWEVER, THE 0.018" WIRE WAS PLACED IN THE VENTRICLE BUT COULD NOT BE ADVANCED, THE WIRE BECAME DISLODGED DURING PLACEMENT. THE IMPELLA CATHETER WAS THEN USED TO GUIDE THE WIRE INTO THE VENTRICLE, BUT IT WAS FACING THE LATENT HEAT PUMP, RESULTING IN IMMEDIATE SUCTION SOUNDS UPON ACTIVATION. THE WIRE WAS REMOVED FOR REPOSITIONING, AND UPON ATTEMPTING TO RE-PASS THE WIRE THROUGH THE IMPELLA, IT EXITED THROUGH THE SUCTION PORT, PREVENTING SUCCESSFUL PLACEMENT. NO TISSUE OR DEBRIS WAS FOUND ON THE SUCTION PORT OR CANNULA. ACCORDING TO THE PHYSICIAN, THE GUIDEWIRE DISLODGMENT OCCURRED DUE TO PROCEDURAL FACTORS. THERE WERE NO ISSUES WITH INSERTION AND NO ISSUES FOUND WITH THE DEVICE. THE PATIENT LATER EXPIRED. THE DEATH WAS ASSESSED AS UNRELATED TO THE DEVICE AND ATTRIBUTED INSTEAD TO CEREBRAL INFARCTION LIKELY DUE TO THE TIME REQUIRED FROM TRANSPORT TO IMPELLA INSERTION. THE REPO

  Patient problems: Hemodynamic instability

  MAUDE report 24457025 ↗
• InjuryFeb 5, 2026Restricted Flow rate; Malposition of Device

  A CASE STUDY REPORTED THAT AN IMPELLA CP WAS INSERTED INTO THE RIGHT FEMORAL ARTERY OF A 58-YEAR-OLD MALE WHO PRESENTED WITH EXERTIONAL FATIGUE TWO WEEKS EARLIER AND WAS DIAGNOSED WITH ISCHEMIC CARDIOMYOPATHY ASSOCIATED WITH THREE-VESSEL DISEASE. HE HAD PERSISTENT LOW CARDIAC FUNCTION (LEFT VENTRICULAR EJECTION FRACTION 12%) AND VENTRICULAR TACHYCARDIA, AND WAS REFERRED TO OUR HOSPITAL FOR REVASCULARIZATION. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT FOR AN OFF-PUMP CORONARY ARTERY BYPASS GRAFT (OPCAB). DURING THE SURGERY, HE EXPERIENCED EPISODES OF HYPOTENSION. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED THAT THE IMPELLA INLET WAS LOCATED AT THE LEFT VENTRICULAR APEX, AND THE OUTLET WAS VISUALIZED ENTERING AND EXITING THE LEFT VENTRICULAR CAVITY JUST ABOVE THE AORTIC VALVE, SUGGESTING A POORLY POSITIONED IMPELLA. FREQUENT POSITIONING ADJUSTMENTS WERE REQUIRED TO MAINTAIN FLOW. BECAUSE THE IMPELLA WAS ALREADY FIXED TO THE THIGH, ADJUSTING ITS POSITION WAS DIFFICULT, AND CIRCULATORY MANAGEMENT WAS NECESSARY WITHOUT RELYING ON THE IMPELLA. AFTER ANASTOMOSIS OF THE LEFT CIRCUMFLEX ARTERY AND RELEASE OF THE DEVICE FROM ROTATION, HEMODYNAMICS REMAINED STABLE, AND THE PROCEDURE W

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 24273339 ↗
• MalfunctionJan 28, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS INITIATED DUE TO HEMODYNAMIC COLLAPSE. A SECOND IMPELLA INSERTION WAS CONSIDERED HOWEVER, CARDIAC RUPTURE OCCURRED, PREVENTING PLACEMENT. AS THE RUPTURE HAPPENED BEFORE ANY IMPELLA RELATED STEPS SUCH AS GUIDEWIRE OR PIGTAIL INSERTION WAS PERFORMED. THE DEATH WAS DETERMINED TO BE UNRELATED TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206488 ↗
• MalfunctionJan 27, 2026Pumping Stopped

  THE USER FACILITY REPORTED A PATIENT ON AN IMPELLA CP FOR PRE-OP PLACEMENT FOR MITRAL VALVE SURGERY. WHEN THE PUMP WAS CLAMPED WITH A SOFT JAW CLAMP TO BLOCK THE AORTA, THE ALARM "PUMP STOP CURRENT CONSUMPTION INCREASE" OCCURRED, AND THE ALARM WENT OFF EVEN WHEN THE PUMP WAS TURNED TO SURGICAL MODE. THE OPERATION WAS CARRIED OUT TO THE END, AND WHEN THE IMPELLER WAS BLED BEFORE THE HEART-LUNG MACHINE WAS LEFT, THE PUMP WOULD NOT RESTART, AND THE CP WAS REMOVED AT THE SAME TIME AS THE HEART-LUNG MACHINE WAS LEFT. THE PATIENT TRANSITION TO THE HEART-LUNG MACHINE AND THE INTRA-AORTIC BALLOON PUMP. THE PATIENT SURVIVED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192382 ↗
• DeathJan 26, 2026Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT NEEDING AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT AS A HIGH RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI). THE INTERVENTION WAS DUE TO DISSOCIATION PROGRESSION IN THE PATIENT. EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS INSERTED FOLLOWING THE CORONARY ARTERY BYPASS GRAFTING AND AN IMPELLA CP. IT WAS FOUND THAT THE ASCENDING AORTA WAS DISSOCIATED FROM THE LEFT MAIN (LM) ARTERY AND THE PCI WAS NOT POSSIBLE. IT WAS REPORTED THAT THE DISSOCIATION PROGRESSED COULD HAVE BEEN DUE TO THE EFFECT OF HEPARINIZATION, BUT THE DETAILED CAUSAL RELATIONSHIP IS UNKNOWN AS ECMO WAS USED, AND HEPARINIZATION WAS NECESSARY. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT EXPIRED.

  Patient problems: Aortic dissection

  MAUDE report 24179668 ↗
• MalfunctionJan 26, 2026Increase in Pressure

  THE COMPLAINANT REPORTED THAT A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE PURGE FLOW RATE HAD DROPPED BY HALF SINCE THE START OF SUPPORT, TO BELOW 5ML/HR. THE DECREASE IN PURGE FLOW RATE BECAME NOTICEABLE ON SEPTEMBER 24TH, SO A PUMP REPLACEMENT WAS PERFORMED, EVEN THOUGH NO ALARM WAS SOUNDED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179086 ↗
• MalfunctionJan 26, 2026Failure to Advance

  THE COMPLAINANT REPORTED THAT AN IMPELLA DEVICE WAS IMPLANTED IN THE PATIENT FOR MECHANICAL CIRCULATORY SUPPORT. WHEN ATTEMPTING TO PLACE THE CPSA, A 0.018-INCH WIRE UNINTENTIONALLY SLIPPED OUT OF THE LEFT VENTRICLE, OBSTRUCTING THE ADVANCEMENT OF THE IMPELLA. RE-WIRING WAS ALSO CONSIDERED, BUT THE TEAM DETERMINED THAT MANIPULATING THE WIRE WOULD INCREASE THE RISK OF VENTRICULAR TACHYCARDIA OR VENTRICULAR FIBRILLATION. ADDITIONALLY, ENDOTHELIAL-LIKE TISSUE WAS OBSERVED TO BE ATTACHED TO THE DEVICE'S OUTLET PORTION. BASED ON THESE FACTORS, A DECISION WAS MADE TO DISCONTINUE THE PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178914 ↗
• InjuryJan 21, 2026Break; Restricted Flow rate; Malposition of Device

  THE COMPLAINANT REPORTED A PATIENT ON IMPELLA SUPPORT WITH A CP PUMP. THE COMPLAINANT REPORTED THAT AN IMPELLA IN AORTA ALARM SOUNDED WHEN THE PATIENT COUGHED. THE PUMP WAS REINSERTED UNDER FLUOROSCOPY, BUT THE PUMP DID NOT RECOVER. A THROMBUS HAD FORMED. THE IMPELLA WAS SURGICALLY REMOVED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24131935 ↗
• InjuryJan 20, 2026Patient Device Interaction Problem

  THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT, THE PATIENT WAS PRESENTED WITH HEMOLYSIS. THE HEMOLYSIS HAD PROGRESSED WITH HAPTOGLOBIN ADMINISTRATION; HOWEVER, DID NOT IMPROVE AND BECAME ANURIA. DIALYSIS WAS STARTED. IT WAS REPORTED THAT THE CAUSE WAS INSUFFICIENT CIRCULATING BLOOD VOLUME DUE TO INFECTION. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT REMAINED ON SUPPORT.

  Patient problems: Hemolysis; Hypovolemia; Renal Failure; Unspecified Infection

  MAUDE report 24124323 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122084. One submission often covers many models, so check the product and lot details in each record.

• Z-2680-2026 · Jun 10, 2026 · Open, Classified
  Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
• Z-2679-2026 · Jun 10, 2026 · Open, Classified
  Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
• Z-2678-2026 · Jun 10, 2026 · Open, Classified
  Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
• Z-1467-2021 · Feb 22, 2021 · Terminated
  AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheter