Impella 0048-0024Recalls & reported problems

Summary

The FDA's MAUDE database contains 296 adverse event reports that list this exact device (DI 00813502011371), received between Oct 29, 2019 and Sep 29, 2026 — classified as 40 deaths, 211 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Restricted Flow rate” (24 reports).

2 FDA recall records name this device's identifier, 1 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 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 ↗

2. Sep 4, 2019Terminated

   This one pump shipped with incorrect pump programming, the initial production working version of the program. The pump would have immediately run at P9 for all selected P-levels, rather than a 10 second ramp up period. The pump may have migrated out of position and possibly caused injury. The positioning and suction alarms were also disabled.

   Z-0345-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 296 reports, in the reporter's own words as published by the FDA.

• DeathSep 29, 2026Adverse Event Without Identified Device or Use Problem

  Clinical Narrative UPDATED 2026-9-25:Since the original reporting and clinical review, additional information regarding patient outcome has been received. The previously reported hemolysis did not resolve despite ongoing support and management. The patient remained on Impella support for more than 3 days following onset of the hemolysis.At the time of the patient's clinical deterioration, the Impella device continued to function as intended at Performance Level P-4, providing 2.4 L/min of flow with 5% dextrose in water and Meylon/sodium bicarbonate purge solution. No device malfunction, interruption in support, or loss of pump performance was reported.Subsequently, the patient expired while on support. Although the device continued to operate as expected, the unresolved hemolysis persisted until the time of death and there was prior thoracic bleeding which contributed to the patient's clinical state. The contribution of the Impella support to the patient's outcome cannot be excluded, despite the absence of any identified device malfunction and continued delivery of expected hemodynamic support parameters.Prior Clinical Narrative:Impella CP SmartAssist was inserted via femoral arter

  Patient problems: Hemolysis

  MAUDE report 50930886 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Impella CP SmartAssist was inserted via left femoral artery access in a 33-year-old male patient presenting with idiopathic cardiomyopathy. The patient's comorbidities and Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage prior to initiation of support were not documented.The clinical course was identified through published literature; therefore, limited information regarding the duration of support and procedural details was available. The publication reported that the patient received heparin anticoagulation with an Activated Clotting Time (ACT) of 160 seconds prior to the procedure and maintained ACT values between 160 and 200 seconds during support.Following completion of treatment and Impella CP SmartAssist explant, bleeding was observed at the femoral access site. Evaluation identified a femoral artery dissection with an associated vessel wall defect. The treating physician performed surgical intervention, including arterial clamping and repair of the vessel defect using a 6-0 Nesplen patch. Following completion of the repair, clamps were released and hemostasis was achieved. Reported operative time was 15 minutes with an estimated blood loss of 150

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

  MAUDE report 50866959 ↗
• InjuryAug 26, 2026Malposition of Device

  An Impella CP was inserted via femoral artery access of unspecified side in an 80-year-old female patient presenting with post-cardiotomy cardiogenic shock and low cardiac output syndrome following mitral valve repair. The patient's medical history was significant for mitral valve regurgitation. The Society for Cardiovascular Angiography and Interventions (SCAI) shock stage prior to initiation of support was not reported.The Impella CP was implanted after the patient failed to wean from cardiopulmonary bypass in the operating room. Device placement was performed using transesophageal echocardiography (TEE) and fluoroscopic guidance. Visualization of the left ventricular apex was reported to be limited due to the presence of mitral valve surgical devices, necessitating repeated echocardiographic assessments to guide device positioning.During positioning of the Impella CP, a left ventricular perforation was observed. The perforation was surgically repaired, and the Impella CP was subsequently explanted. Extracorporeal membrane oxygenation (ECMO) was then initiated to provide ongoing hemodynamic support. The duration of Impella support was approximately two hours. No pump performance

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

  MAUDE report 50451270 ↗
• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  Clinical Narrative:An Impella CP was inserted via right femoral artery access in a male patient of undocumented age presenting with acute myocardial infarction and cardiogenic shock. The patient's clinical condition prior to support initiation was reported as SCAI Shock Stage E. Prior to Impella CP implantation, the patient was receiving extracorporeal membrane oxygenation (ECMO) as the primary support modality, as well as inotropes, vasopressors, and respiratory support. The Impella CP was utilized for left ventricular venting during ECMO support.One day after implantation, a purge cassette malfunction was identified when a purge occlusion alarm was displayed on the Automated Impella Controller. The purge cassette was removed and replaced. Following replacement, purge pressure and purge flow returned to appropriate levels. There was no interruption in hemodynamic support and no reported patient injury related to the event.During the course of support, the treating team also expressed concerns for possible heparin-induced thrombocytopenia (HIT). As a precaution, the purge solution was changed to sodium bicarbonate and systemic anticoagulation was transitioned to argatroban. Platele

  Patient problems: Thrombocytopenia

  MAUDE report 50435885 ↗
• MalfunctionAug 20, 2026Increase in Pressure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50344023 ↗
• DeathAug 10, 2026Increase in Pressure; Patient Device Interaction Problem

  Clinical Narrative:Impella CP was percutaneously (side unspecified) femoral artery site in a 84 year-old male patient presenting with Acute Myocardial Infarction/ Cardiogenic Shock. 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 was not provided.While on support, the device functioned as intended at P-4 at 0.8 Liter/minute with unknown purge solution.Approximately one day following implantation, a decrease in purge flow and frequent bad position alarms were observed. Despite anticoagulation management, including maintenance of Activated Clotting Time (ACT) between 160-180 seconds, activated partial thromboplastin time( aPTT) of approximately 50 seconds, and addition of heparin (5 U/mL) to the purge solution, thrombus formation was suspected. Due to the risk of progressive purge flow reduction and potential pump stoppage, the device was replaced. Upon explant, red thrombus was observed adherent to the pump inlet and white thrombus was noted on the impeller and outlet, with pathology evaluation planned. Blood clots were also reported in the patie

  Patient problems: Thromboembolism

  MAUDE report 50194977 ↗
• InjuryAug 3, 2026Restricted Flow rate; Patient Device Interaction Problem

  Clinical Narrative US:Impella CP was inserted via left femoral artery in a 79-year-old male patient presenting with Acute Myocardial Infarction and Cardiogenic Shock. The patient¿s comorbidities were not shared. The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage was not noted, but after implant of the Impella the SCAI Shock Stage is documented at Stage C.The Physician added Extra Corporeal Membrane Oxygenation (ECMO) to the Impella CP support as during the coronary angioplasty there was slow flow when intervening upon the right coronary artery. The Impella CP would vent the ventricle for the primary support ECMO.While on support the the device functions as expected, Performance Level P-3 with 1.9L/min flow with 5% Dextrose in water with Heparin in the purge solution.On the second day of support the pump flow rate had dropped to zero. Echocardiography and volume status assessments showed no abnormalities and positioning and motor waveforms appeared normal. As the patient was clinically improving the pump was weaned and explanted. The ECMO remained on to support the patient. At the Impella CP exp

  Patient problems: Thromboembolism

  MAUDE report 50122705 ↗
• InjuryJul 28, 2026Restricted Flow rate; Malposition of Device; Patient Device Interaction Problem

  Clinical Narrative:An Impella CP was inserted via the femoral artery, of undocumented side, to support the 75-year-old male patient admitted with known coronary artery disease and plan for the Off-Pump Coronary Artery Bypass (OPCAB) surgery. The patient did present per documentation in Society for Cardiovascular Angiography and Interventions (SCAI) Stage C Shock at the time of pump insertion. The patient had a medical history inclusive of hypertension, dyslipidemia, chronic kidney disease, and heart disease.The Impella CP supported the patient for 4 days in (b)(6) of 2024, and was successfully weaned and explanted. The team in Japan published upon the support. The publication was discovered by a social media post in July 2026.The publication noted the Impella CP was placed pre-operatively and supported for the OPCAB. While in the operating suite the pump became malpositioned deeper within the left ventricle. The positioning of the pump allowed for the mitral valve leaflet to be interacted with and the team noted new mitral valve regurgitation. After 90 minutes the patient condition deteriorated and the patient was noted to be hypotensive. The team made the decision to escalate care

  Patient problems: Low Blood Pressure/ Hypotension; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 50054905 ↗
• DeathJun 17, 2026Patient Device Interaction Problem

  ANAN IMPELLA CP DEVICE WAS INSERTED VIA AN UNSPECIFIED FEMORAL ARTERIAL ACCESS SITE IN AN (B)(6) MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK, WITH A PRE-SUPPORT CLINICAL CONDITION CONSISTENT WITH SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE C. THE PATIENT HAD MULTIVESSEL ACUTE CORONARY SYNDROME AND WAS INITIALLY SUPPORTED WITH AN INTRA-AORTIC BALLOON PUMP; HOWEVER, BLOOD PRESSURE COULD NOT BE MAINTAINED, AND THE PATIENT PROGRESSED INTO CARDIOGENIC SHOCK. THE FOLLOWING DAY, SUPPORT WAS ESCALATED WITH PLACEMENT OF AN IMPELLA CP DEVICE TO TREAT THE REMAINING CORONARY LESIONS. ON (B)(6), THE PATIENT DEVELOPED ACUTE NEUROLOGIC DETERIORATION, INCLUDING DISORIENTATION AND LOSS OF CONSCIOUSNESS. COMPUTED TOMOGRAPHY (CT) IMAGING CONFIRMED A CEREBRAL HEMORRHAGE. GIVEN THE PATIENT'S ADVANCED AGE AND OVERALL CLINICAL CONDITION, NO FURTHER INTERVENTIONS WERE PURSUED. THE IMPELLA CP DEVICE WAS REMOVED, AND CARE WAS WITHDRAWN. THE PATIENT SUBSEQUENTLY EXPIRED. THE PHYSICIAN REPORTED THAT THE CAUSE OF DEATH WAS UNKNOWN, AND ANTICOAGULATION PARAMETERS, INCLUDING PTT, WERE WITHIN ACCEPTABLE RANGE. THE REPORTED INTRACRANIAL HEMORR

  Patient problems: Stroke/CVA

  MAUDE report 25531999 ↗
• MalfunctionJun 9, 2026Device Sensing Problem

  THE COMPLAINANT REPORTED THAT DURING IMPELLA CP SUPPORT, THE PLACEMENT SIGNAL WAVEFORM WAS NO LONGER DISPLAYED. THE ISSUE WAS IDENTIFIED AS A LOSS OF PLACEMENT SIGNAL ASSOCIATED WITH THE OPTICAL SENSOR DURING ICU ADMINISTRATION, WITHOUT A SPECIFIC TRIGGERING EVENT. AT THE TIME THE PLACEMENT SIGNAL WAS NOT DISPLAYED, THE ARTERIAL PRESSURE WAVEFORM REMAINED NORMAL. THE DEVICE CONTINUED TO PROVIDE SUPPORT DURING USE. DATA LOGS WERE NOT AVAILABLE FOR REVIEW. THE DEVICE WAS NOT FULLY RETAINED; IT WAS REPORTED THAT ONLY THE IMPELLA CP CATHETER WAS RECOVERED. HOWEVER, AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE DEVICE WAS SUBSEQUENTLY EXPLANTED SUCCESSFULLY AFTER WEANING. THE EXPLANT WAS NOT CONSIDERED PREMATURE AND WAS UNRELATED TO THE REPORTED EVENT. THE PATIENT¿S OUTCOME AT THE TIME OF EXPLANT WAS SURVIVED. NO SIGNS OR SYMPTOMS OF PATIENT INJURY OR PATIENT HARM WERE REPORTED IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25447419 ↗
• InjuryJun 4, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PURGE SOLUTION WAS CHANGED TO SODIUM BICARBONATE IN THE 5% DEXTROSE IN WATER AFTER DIAGNOSIS OF SUBARACHNOID HEMORRHAGE. AN IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 74-YEAR-OLD MALE PRESENTING WITH ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS). THE PATIENT¿S COMORBIDITIES WERE UNSPECIFIED, HOWEVER, THE PATIENT REQUIRED MULTIPLE VASOPRESSORS, INOTROPIC SUPPORT, AND MECHANICAL CIRCULATORY SUPPORT (MCS), INCLUDING AN INTRA-AORTIC BALLOON PUMP (IABP) AND EXTRACORPOREAL MECHANICAL CIRCULATION (ECMO). THE PATIENT WAS NOTED TO BE IN SCAI STAGE D SHOCK BEFORE INITIATION OF IMPELLA CP SUPPORT. IT WAS REPORTED THAT ENDOVASCULAR TREATMENT WAS NECESSARY PRIOR TO INSERTION OF IMPELLA CP DEVICE DUE TO "POOR VASCULAR CHARACTERISTICS OF THE LOWER EXTREMITIES." IT WAS ALSO REPORTED THAT THE IMPELLA CP DEVICE WAS INSERTED THROUGH A 16F DRY SEAL SHEATH. AT THE TIME OF DEVICE PLACEMENT, A SLIGHT DIFFERENCE IN PUPILLARY REFLEX BETWEEN THE LEFT AND RIGHT EYES WAS NOTED. 6 DAYS AFTER IMPELLA INSERTION, A COMPUTED TOMOGRAPHY (CT) SCAN OF THE BRAIN WAS PERFORMED IN RESPONSE TO THE PATIENT HAVING A SUDDEN DROP IN BLOOD PRESSURE. THE SCAN REVEALED A S

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Stroke/CVA

  MAUDE report 25390724 ↗
• InjuryJun 2, 2026Malposition of Device; Patient Device Interaction Problem

  AN 80-YEAR-OLD MALE WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK UNDERWENT IMPELLA CP SUPPORT VIA RIGHT FEMORAL ARTERIAL PERCUTANEOUS ACCESS ON (B)(6) 2026. ON THE MORNING OF (B)(6), THE PATIENT DEVELOPED CARDIAC TAMPONADE, AND IMAGING REVEALED LEFT VENTRICULAR PERFORATION LOCALIZED BETWEEN THE LATERAL AND POSTERIOR WALLS. SURGICAL REPAIR WAS PERFORMED. THE PHYSICIAN DETERMINED THAT THE PERFORATION DID NOT CORRESPOND WITH THE INFARCTION SITE AND ATTRIBUTED THE EVENT TO THE IMPELLA DEVICE, NOTING THAT THE PUMP MAY HAVE INITIALLY BEEN POSITIONED SLIGHTLY TOWARD THE POSTERIOR WALL, CLOSER TO THE LATERAL WALL, WHICH MAY HAVE CONTRIBUTED TO THE PERFORATION. THE PATIENT HAD REPORTED PAIN BETWEEN IMPLANTATION AND THE TIME OF DIAGNOSIS, ALTHOUGH THE EXACT TIMING OF THE PERFORATION COULD NOT BE DETERMINED. THE IMPELLA DEVICE WAS SUBSEQUENTLY REMOVED ON (B)(6) 2026, AS IT WAS NO LONGER REQUIRED. FOLLOWING SURGICAL REPAIR, THE PATIENT RECOVERED, WAS EXTUBATED, AND WAS REPORTED TO BE STABLE WITH PLANS FOR DISCHARGE FROM THE ICU.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pain

  MAUDE report 25360205 ↗
• DeathMay 21, 2026Failure to Advance; No Apparent Adverse Event

  AN IMPELLA CP WAS BEING INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 70 YEAR OLD MALE PATIENT ADMITTED IN WITH INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE E SHOCK. THE PATIENT'S UNDERLYING MEDICAL HISTORY WAS INCLUSIVE OF PERIPHERAL ARTERIAL DISEASE. THE ASCENDING AORTA WAS OCCLUDED, CALCIFICATION AND TORTUOUSITY, AS WELL AS ANEURYSM. THE UNDERLYING VASCULAR PATH PREVENTED THE SUCCESSFUL DELIVERY OF THE IMPELLA TO THE LEFT VENTRICLE. THE ADVANCEMENT OF THE PRODUCT WAS ABORTED. ON THE DAY OF THE ABORTED DELIVERY THE PATIENT EXPIRED. THE TEAM IN JAPAN DID STATE THE PATIENT HAD FAILED TO RECOVER FROM THE CARDIAC ARREST AND THE INABILITY TO RECEIVE TREATMENT WERE CONTRIBUTING FACTORS TO THE PATIENT OUTCOME. THE DEVICE WILL BE CONSERVATIVELY REPORTED FOR DEATH; HOWEVER, THE DEATH IS MOST LIKELY ATTRIBUTED TO THE PATIENT'S UNDERLYING CRITICAL CLINICAL CONDITION POST CARDIAC ARREST AS WELL AS THE DELIVERY FAILURE OF THE CP DUE TO NATIVE ANATOMY.

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

  MAUDE report 25240506 ↗
• InjuryMay 6, 2026Failure to Advance

  CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED INTO THE FEMORAL ARTERY IN A PATIENT PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), PRIOR TO INITIATION OF SUPPORT. THE PATIENT IDENTIFIERS AND COMORBIDITIES ARE UNKNOWN. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT FOR A PROTECTED PERCUTANEOUS INTERVENTION (PCI). DURING THE PROCEDURE, THERE WAS DIFFICULTY INSERTING THE CATHETER DUE TO TORTUOSITY NEAR THE COMMON ILIAC ARTERY BIFURCATION. PRE-PROCEDURE CONTRAST IMAGING WAS NOT PERFORMED; THEREFORE, THE VESSEL CHARACTERISTICS COULD NOT BE DETERMINED PRE-IMPELLA INSERTION. THE IMPELLA WAS REMOVED. THE POST-PROCEDURE OUTCOME IS SURVIVED AT EXPLANT. THE PATIENT CONTINUED ON INTRA-AORTIC BALLOON PUMP (IABP) SUPPORT. THE IMPELLA WILL BE REPORTED FOR THE EARLY REMOVAL OF THE DEVICE; HOWEVER, THE REMOVAL WAS PERFORMED WITH NO CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25092832 ↗
• DeathMay 6, 2026Patient Device Interaction Problem

  CLINICAL NARRATIVE: AN IMPELLA CPSA DEVICE WAS INSERTED INTO THE RIGHT FEMORAL ARTERY IN A 77-YEAR-OLD FEMALE PATIENT PRESENTING IN SCAI STAGE A SHOCK. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT FOR A HIGH-RISK CARDIAC SURGERY: VENTRICLE SEPTAL (VS) REPAIR PROCEDURE. DURING THE PROCEDURE, A THROMBUS FORMED ON THE SHAFT OF THE IMPELLA PRIOR TO THE VS PROCEDURE. AFTER THREE DAYS ON SUPPORT, THE DEVICE WAS REMOVED WITH AN ESCALATION OF THERAPY TO AN IMPELLA 5.5. AFTER REMOVAL, THE THROMBUS REMAINED IN THE DESCENDING AORTA. THE PATIENT WAS TRANSFERRED TO CARDIOPULMONARY BYPASS. SUBSEQUENTLY, THE THROMBUS MOVED, REQUIRING A THROMBECTOMY. THE POST-PROCEDURE OUTCOME IS SURVIVED AT EXPLANT. THE IMPELLA FUNCTIONED AT P-2 AT 0.9L/MIN AS INTENDED. THROMBUS (THROMBOSIS) CAN OCCUR DUE TO INADEQUATE ANTICOAGULATION, AND IS AN ADVERSE EVENT ASSOCIATED WITH IMPELLA'S MECHANICAL SUPPORT.

  Patient problems: Thromboembolism

  MAUDE report 25092621 ↗
• MalfunctionMay 5, 2026Failure to Advance

  THE COMPLAINANT REPORTED THAT A PATIENT WAS TO BE IMPLANTED WITH AN IMPELLA CP VIA PERCUTANEOUS RIGHT FEMORAL ARTERY FOR MECHANICAL CIRCULATORY SUPPORT. SEVERE TORTUOSITY MADE THE IMPELLA INSERTION DIFFICULT. THE INSERTION WAS ABANDONED. THE PATIENT'S OUTCOME IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085612 ↗
• InjuryApr 30, 2026Patient Device Interaction Problem

  CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED VIA FEMORAL ARTERIAL ACCESS (SIDE NOT REPORTED) IN A 27-YEAR-OLD MALE PATIENT WITH A HISTORY OF MYOCARDITIS AND CARDIOMYOPATHY, PRESENTING IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE D SHOCK. FOLLOWING IMPELLA CP PLACEMENT, THE PATIENT¿S CLINICAL CONDITION CONTINUED TO WORSEN, AND VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS INITIATED ON THE SAME DAY, RESULTING IN CONCURRENT ECMO AND IMPELLA SUPPORT. ON THE FOLLOWING DAY, THE PATIENT WAS DIAGNOSED WITH A CEREBRAL HEMORRHAGE. AT THE TIME OF REPORTING, THE PATIENT REMAINED ON COMBINED ECMO AND IMPELLA SUPPORT, AND ONGOING CLINICAL MANAGEMENT WAS CONTINUING. STROKE IS A KNOWN RISK IN PATIENTS REQUIRING MECHANICAL CIRCULATORY SUPPORT. THE PATIENT REMAINED ON SUPPORT AT THE TIME OF THE EVENT LISTED.

  Patient problems: Stroke/CVA

  MAUDE report 25046106 ↗
• MalfunctionApr 20, 2026Failure to Advance

  THE COMPLAINANT REPORTED THAT A PATIENT WAS TO BE IMPLANTED WITH AN IMPELLA CP VIA PERCUTANEOUS RIGHT FEMORAL ARTERY FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED TO BE DIFFICULT TO INSERT THE PUMP. THE PUMP WAS NOT USED. INSERTION WAS STOPPED BECAUSE CALCIFICATION WAS OBSERVED IN THE BLOOD VESSEL DURING INSERTION, MAKING IT DIFFICULT TO ADVANCE THE DEVICE. RESISTANCE WAS ENCOUNTERED WHEN THE TIP REACHED THE VICINITY OF THE AORTIC VALVE, MAKING FURTHER ADVANCEMENT DIFFICULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924912 ↗
• DeathApr 10, 2026Adverse Event Without Identified Device or Use Problem

  CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 81 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE C AT PUMP IMPLANT. PRIOR TO THE CP PLACEMENT THE PATIENT WAS SUPPORTED BY AN INTRA-AORTIC BALLOON PUMP (IABP) AND EXTRA-CORPOREAL MEMBRANE OXYGENATION (ECMO). THE PATIENT'S UNDERLYING MEDICAL HISTORY WAS NOT SHARED. WHILE ON THE CP-ECMO SUPPORT THE PATIENT SUFFERED FROM A HEMORRHAGIC STROKE. THE ACT WAS MANAGED AT 160-180SECONDS WITH HEPARIN ANTICOAGULATION. ANTICOAGULATION NECESSARY FOR THE PUMP PLACEMENT AND SUPPORT CAN CONTRIBUTE TO BLEEDING. AFTER THE STROKE THE PATIENT DID EXPIRE. THE RELATIONSHIP OF THE DEATH TO THE CP WAS NOTED TO BE "UNCLEAR" PER THE PHYSICIAN IN JAPAN. FURTHER CLARIFICATION IS BEING SOUGHT.

  Patient problems: Stroke/CVA

  MAUDE report 24838838 ↗
• DeathApr 7, 2026Adverse Event Without Identified Device or Use Problem

  CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 70 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK. THE UNDERLYING HISTORY WAS NOT SHARED. THE PUMP WAS SUPPORTING ALONG WITH EXTRA-CORPOREAL MEMBRANE OXYGENATION (ECMO). WHILE ON SUPPORT THE CP ACCESSED LIMB HAD LOST PULSES, AND SO TO TROUBLESHOOT AND TREAT THE ISCHEMIA AN ANTEGRADE PUNCTURE WAS MADE FOR PERFUSION. IT WAS REPORTED THERE WAS NO IMPROVEMENT IN LIMB ISCHEMIA. ADDITIONALLY THE ECMO ACCESSED LIMB WAS ISCHEMIC. THE TEAM DID ACKNOWLEDGE THE VESSELS TO BE SMALL IN DIAMETER. AFTER JUST OVER 1 DAY OF SUPPORT THE PATIENT EXPIRED. THE DEATH IS CONSERVATIVELY BEING REPORTED ALTHOUGH AN UNLIKELY CONTRIBUTING FACTOR TO THE DEATH, AND MORE LIKELY THE PATIENT'S PRESENTING NATIVE CRITICAL CONDITION. ISCHEMIA MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS SEVERE PERIPHERAL VASCULAR DISEASE, UNDERLYING CRITICAL ILLNESS, HEMODYNAMIC INSTABILITY, AND VASCULAR ACCESS CHARACTERISTICS.

  Patient problems: Ischemia

  MAUDE report 24799772 ↗
• MalfunctionMar 31, 2026Failure to Advance

  THE COMPLAINANT REPORTED A PATIENT WAS ATTEMPTED TO BE IMPLANTED WITH AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THERE WAS AN ATTEMPT TO USE IMPELLA CP FOR NON-PASSING LOW EF, LM-RELATED LESIONS, BUT DIFFICULTY IN INSERTION IN THE USUAL WAY DUE TO INGUINAL CALCIFICATION, ABDOMINAL ANEURYSM, AND RESTING CALCIFICATION. REPLACED IT WITH ANOTHER HARD WIRE AND TRIED TO PULL THE PIGTAIL PART WITH A SNARE, BUT COULD NOT INSERT. PCI ENFORCEMENT WITHOUT IMPELLA SUPPORT. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744328 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE FEMORAL ARTERY IN A 79-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), SCAI SHOCK STAGE¿C. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE IMPELLA¿CP WAS PLACED FOR AN LAD STEMI, AND PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED. ECHO-GUIDED PUNCTURE WAS USED FOR ACCESS, AND A MEDIKIT 16¿FR SHEATH WAS UTILIZED. NO ISSUES WERE REPORTED AT THE TIME OF INSERTION. THE FOLLOWING NIGHT, BLEEDING DEVELOPED AT THE INSERTION SITE. AS THE PATIENT¿S HEMODYNAMICS HAD STABILIZED AND THE SUPPORT LEVEL HAD ALREADY BEEN REDUCED IN PREPARATION FOR WEANING, SURGICAL REMOVAL OF THE DEVICE WAS PLANNED. THE PATIENT RECEIVED FOUR UNITS OF BLOOD TRANSFUSION AND REMAINED HEMODYNAMICALLY STABLE. MANAGEMENT WAS CONDUCTED WHILE THE PATIENT WAS AWAKE, AND PER THE TREATING PHYSICIAN, BODY MOVEMENT WAS FELT TO HAVE TRIGGERED THE ACCESS-SITE BLEEDING. THERE WAS ALSO INFORMATION THAT THE PARTIAL THROMBOPLASTIN TIME (PTT) HAD BEEN PROLONGED FOR A PERIOD, ALTHOUGH SPECIFIC VALUES WERE NOT AVAILABLE. THE PATIENT SURVIVED TO EXPLANT. THE REPORTED MAJOR BLEED REQUIRING BLOOD TRANSFUSION IS

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24741167 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  AN IMPELLA CP DEVICE WAS INSERTED VIA THE FEMORAL ARTERY IN A 49-YEAR-OLD MALE PATIENT PRESENTING WITH CARDIOMYOPATHY. THE PATIENT¿S HISTORY WAS UNKNOWN. SUBCORTICAL BLEEDING OCCURRED AFTER IMPELLA INSERTION. CARDIAC FUNCTION WAS RESTORED, AND THE IMPELLA WAS SUBSEQUENTLY REMOVED. EXTERNAL PRESSURE WAS REDUCED, BUT THE PATIENT¿S LEVEL OF CONSCIOUSNESS DID NOT IMPROVE. HEPARIN USE FOR ANTICOAGULATION FOLLOWING IMPELLA INSERTION WAS CONSIDERED CLINICALLY RELEVANT. EXTERNAL COMPRESSION WAS ALSO NOTED AS A CONTRIBUTING FACTOR. THE PATIENT¿S PROCEDURAL OUTCOME WAS UNKNOWN. THE REPORTED STROKE IS CONSISTENT WITH THE PATIENT¿S UNDERLYING CRITICAL ILLNESS AND CEREBROVASCULAR VULNERABILITY AND MAY BE INFLUENCED BY ANTICOAGULATION THERAPY AND EXTERNAL COMPRESSION.

  Patient problems: Stroke/CVA

  MAUDE report 24638725 ↗
• DeathMar 18, 2026Adverse Event Without Identified Device or Use Problem

  CLINICAL RATIONALE: A 70 YEAR OLD MALE PATIENT UNDERWENT PLACEMENT OF AN IMPELLA CP DEVICE HEMODYNAMIC SUPPORT IN THE SETTING OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK. THE DEVICE WAS IMPLANTED PERCUTANEOUSLY VIA FEMORAL ARTERIAL ACCESS ON (B)(6) 2026 AT 20:30. FOLLOWING IMPELLA CP PLACEMENT AND PRE PCI PREPARATION IN THE CULPRIT LAD, THE PATIENT DEVELOPED CARDIAC TAMPONADE UPON CLINICAL REASSESSMENT. AN EMERGENCY SURGICAL INTERVENTION WAS INITIATED. ADDITIONAL INFORMATION RECEIVED ON 2026/03/16 CONFIRMED THAT THE SURGICAL PROCEDURE WAS PERFORMED WITH BOTH THE IMPELLA CP AND ECMO IN PLACE. AN OPEN CHEST APPROACH WAS UTILIZED, DURING WHICH A CARDIAC RUPTURE CLOSURE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE CUSTOMER REPORTED THAT THIS INCIDENT IS A MECHANICAL COMPLICATION OF MI AND IS NOT RELATED TO IMPELLA. THE PATIENT REMAINS IN THE ICU ON ONGOING IMPELLA AND ECMO SUPPORT, AND EXPLANT HAS NOT YET OCCURRED. BASED ON THE CLINICAL COURSE AND AVAILABLE INFORMATION, THE EVENT IS CONSISTENT WITH A KNOWN MECHANICAL COMPLICATION OF MYOCARDIAL INFARCTION. THERE IS NO EVIDENCE SUGGESTING THAT THE IMPELLA CP DEVICE CAUSED OR CONTRIBUTED TO THE CARDIAC RUPTURE OR TAMPONADE. THE PATI

  Patient problems: Cardiac Tamponade

  MAUDE report 24627912 ↗
• MalfunctionMar 17, 2026Priming Problem

  A COMPLAINANT REPORTED THAT A PATIENT WAS IMPLANTED WITH AN IMPELLA CP VIA PERCUTANEOUS RIGHT FEMORAL ARTERY FOR MECHANICAL CIRCULATORY SUPPORT. IN THE CASE, THE YOUNG DOCTOR WITH LITTLE EXPERIENCE WITH IMPELLA INSERTION WAS IN CHARGE. THEY WERE ACCUSTOMED TO INSERTION AND BEGAN PRIMING EARLY. AFTER PRIMING WAS FINISHED, PURGE FLUID WAS CHECKED ON THE TRAY, BUT IT DID NOT FLOW. THE YOUNG DOCTOR WAS THE FIRST TO CORRECT HEMODYNAMICS, SO PURGE FLUID DID NOT FLOW, BUT STARTED INTRODUCING IT. A SENIOR DOCTOR ARRIVED AT THE TIME OF INTRODUCTION, AND SAID IT WAS ESSENTIAL TO CHECK IF THE PURGE FLUID WAS FLOWING. REMOVED AND CHECKED THE FLOW FLUID OF THE PURGE AGAIN, BUT IT DID NOT FLOW. SUSPECTED INITIAL FAILURE OF PRODUCT SO A SECOND BOTTLE WAS OPENED. AFTER THAT, IT WAS INTRODUCED WITHOUT PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616089 ↗

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-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-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-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-0980-2024 · Dec 27, 2023 · Open, Classified
  Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5
• 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.

…and 6 more.