Impella 0048-0032Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00813502011388), received between Jul 10, 2019 and Jun 18, 2025 — classified as 3 deaths, 32 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (3 reports).

3 FDA recall records name this device's identifier, 3 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. 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 ↗

2. 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 ↗

3. 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-2115-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• DeathJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED THAT A PATIENT ENDURED HEMOLYSIS DURING IMPELLA CP SUPPORT. FOLLOWING IMPLANT, THE PATIENT BEGAN TO DEVELOP HEMATURIA. THE SUPPORT LEVEL WAS REDUCED TO P-2 AND THE DEVICE WAS REPOSITIONED TO ADDRESS THE CONDITION. THE FOLLOWING DAY, THE DECISION WAS MADE TO EXPLANT THE PUMP AS THE HEMOLYSIS HAD NOT YET RESOLVED. THE PATIENT PASSED AWAY THE NEXT DAY. THERE IS NOT ENOUGH EVIDENCE TO EXCLUDE THE IMPELLA AS AN ASSOCIATED FACTOR IN THE PATIENT'S OUTCOME.

  Patient problems: Hemolysis

  MAUDE report 22282601 ↗
• MalfunctionOct 9, 2024Difficult to Insert; Difficult to Insert

  THE COMPLAINANT REPORTED A PATIENT OF UNKNOWN RACE/ETHNICITY IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS ATTEMPTED TO BE IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE PHYSICIAN WAS UNABLE TO CROSS THE DEVICE INTO THE PATIENT DURING AN EMERGENT CASE, AND THE INSERTION WAS ABORTED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20412995 ↗
• InjuryOct 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THE PATIENT SUFFERED ONE OR MORE STROKES POST IMPELLA EXPLANT. ACTIONS TAKEN ARE UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Stroke/CVA

  MAUDE report 20385679 ↗
• InjuryAug 28, 2024Restricted Flow rate; Restricted Flow rate

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. HEMOSTASIS WAS ACHIEVED. WHILE ON SUPPORT THE PATIENT EXPERIENCED CONTINUOUS SUCTION ALARMS. ECHO HAD BEEN OBTAINED PRIOR TO THAT AND PER CARDIOLOGIST IMPELLA WAS IN ¿OK POSITION.¿ THE PATIENT STARTED HAVING RUNS OF WIDE COMPLEX TACHYCARDIA WITH A PULSE AFTER ARRIVING. THE PROVIDER AGREED TO GET ANOTHER ECHO GIVEN NEW PERSISTENT SUCTION ALARMS NOW ON P2 AND ARRHYTHMIAS. IMPELLA NOTED AT 4CM FROM AV ANNULUS, REPOSITIONED AND MEASURED 3.6 CM FROM AV ANNULUS. NEW CM MARKING AT 90.5. P LEVEL INCREASED TO P4, BUT THE PATIENT CONTINUES TO HAVE SUCTION. THE PATIENT HAS KNOWN MITRAL REGURGITATION (MR), DIFFICULT TO ASSESS AT THIS TIME WITH COLOR DOPPLER. SUCTION ALARMS DISABLED, NOTIFIED PROVIDER AND NURSE AT BEDSIDE TO MONITOR CLOSELY FOR SIGNS OF HEMOLYSIS. THE PATIENT ALSO HAD HEMOSTASIS WHICH HAD BEEN ACHIEVED WITH THE TWO PER CLOSE SUTURES THAT HAD BEEN PLACED AT TIME OF INSERTION. THE PATIENT WAS SUCCESSFULLY WEANED FROM THE IMPELLA AND THE DEVICE EXPLANTED.

  Patient problems: Arrhythmia; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20092828 ↗
• DeathAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT, THE PATIENT DEVELOPED HEMOLYSIS, THE PATIENT¿S URINE WAS REPORTED TO BE VERY DARK RED, URINE ANALYSIS RED BLOOD COUNT WAS LESS THAN TEN AND MULTIPLE LABORATORY RESULTS WERE HEMOLYZED. IT WAS REPORTED ATTEMPTS WERE MADE TO REPOSITION THE IMPELLA, HOWEVER THE PATIENT¿S ANATOMY MADE PROPER PLACEMENT IMPOSSIBLE. REPORTEDLY FURTHER HEMOLYZED LABORATORY RESULTS WERE NOTED ON (B)(6) 2021, DESPITE REPOSITIONING, AND THE CONTINUOUS RENAL REPLACEMENT THERAPY. IT WAS ALSO REPORTED ON (B)(6) 2021 THAT THE PATIENT¿S EJECTION FRACTION WAS VERY POOR WITH NO APPARENT RECOVERY AND THE PATIENT CODED THREE TIMES THE DAY BEFORE. THE PATIENT WAS TURNED DOWN FOR SURGICAL INTERVENTION AND THE FAMILY WAS BEING CONTACTED FOR POSSIBLE WITHDRAWAL OF CARE. SURVIVAL OUTCOME AT EXPLANT NOTED THE PATIENT EXPIRED. MEDICAL SAFETY REVIEW OF THE EVENT NOTED THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Cardiac Arrest; Hemolysis

  MAUDE report 20092644 ↗
• DeathAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT, THE PATIENT EXPERIENCED A STROKE. SURVIVAL OUTCOME AT EXPLANT NOTED THE PATIENT EXPIRED. MEDICAL SAFETY REVIEW OF THE EVENT NOTED THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Stroke/CVA

  MAUDE report 20092068 ↗
• InjuryAug 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED WHILE ON IMPELLA CP SUPPORT, THE PATIENT EXPERIENCED BLEEDING AT THE IMPELLA INSERTION SITE. THE PERCLOSE SUTURES WERE TIGHTENED DOWN AND HEMOSTASIS WAS ACHIEVED. IT WAS NOTED THAT THE PATIENT EXPIRED WHILE ON SUPPORT. MEDICAL SAFETY REVIEW OF THE EVENT NOTED THE USE OF THE DEVICE CANNOT CONCLUSIVELY BE ASSOCIATED WITH THE OUTCOME (PATIENT'S DEMISE).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20060330 ↗
• MalfunctionAug 22, 2024Failure to Advance; Failure to Advance

  THE USER FACILITY REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THE INSERTION OF THE IMPELLA WAS CHALLENGING, WITH THE PUMP BEING TAKEN OUT AND REPOSITIONED ON 3 SEPARATE ATTEMPTS. THE PUMP WAS SUCCESSFULLY IMPLANTED AND THE PLACEMENT WAS VERIFIED WITH AN ECHOCARDIOGRAM. SURVIVAL OUTCOME NOTED THE PATIENT EXPIRED. NO ALLEGATIONS WERE MADE TOWARD THE IMPELLA CP AS THE CAUSE OF DEATH. MEDICAL SAFETY REVIEW OF THE EVENT NOTED USE OF THE DEVICE CANNOT CONCLUSIVELY BE ASSOCIATED WITH THE OUTCOME (PATIENT'S DEMISE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20032223 ↗
• InjuryAug 22, 2024Positioning Failure; Positioning Failure

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT WHILE THE PATIENT WAS ON IMPELLA CP SUPPORT, THE PATIENT BECAME SEPTIC. IT WAS ALSO REPORTED THAT THE IMPELLA WAS IN THE WRONG POSITION, AND POSITION COULD NOT BE CORRECTED WITH REPOSITIONING ATTEMPTS. THE MEDICAL TEAM DECIDED TO EXPLANT THE IMPELLA DUE TO POSITIONING ISSUES AND SEPSIS. THE PATIENT WAS SUCCESSFULLY WEANED AND THE IMPELLA WAS EXPLANTED.

  Patient problems: Sepsis

  MAUDE report 20030287 ↗
• MalfunctionAug 22, 2024Failure to Pump; Failure to Pump

  THE COMPLAINANT REPORTED THAT THE PATIENT ON IMPELLA CP HAD PUMP STOP. IMPELLA PLACED. DURING SUPPORT IT WAS REPORTED THAT INITIAL IMPELLA (SN (B)(6)) PLACED AND WHEN STARTED "IMPELLA STOPPED" ALARM NOTED. PER CCL STAFF INITIAL PUMP WAS STARTED WITH GUIDEWIRE IN PLACE. THIS IMPELLA WAS EXPLANTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20028796 ↗
• MalfunctionAug 22, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE COMPLAINANT REPORTED A PATIENT NOTED AS HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION NEEDING AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THERE WERE SUCTION ALARMS DIRECTLY AFTER IMPLANTING THE IMPELLA. A KINK WAS NOTED UNDER FLUOROSCOPY. THE PHYSICIAN ATTEMPTED TO REPOSITION THE DEVICE BUT WAS UNABLE TO UNKINK THE CATHETER. THE IMPELLA WAS REMOVED, ASSESSED, AND REIMPLANTED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20026612 ↗
• InjuryAug 21, 2024Restricted Flow rate; Increase in Pressure; Restricted Flow rate; Increase in Pressure

  US COMPLAINANT REPORTED PATIENT WAS PLACED ON IMPELLA CP SUPPORT. IT WAS REPORTED PURGE FLOW WAS DECREASING OVER COURSE OF NURSE¿S SHIFT. NURSE STATED SHE WALKED INTO AN ALARM THAT SAID THE IMPELLA STOPPED DUE TO HIGH MC. ABIOMED SUPPORT DID NOT SEE THIS ON IC. AS SUPPORT SPOKE TO NURSE, THE PF STARTED TO TREND UP AND PP DECREASE. PATIENT HAD LIVER SHOCK WITH NO COAGULATION SO TPA WAS NOT AN OPTION. NURSE WAS TO MONITOR FOR NOW AND GET A PURGE CASSETTE AVAILABLE IN CASE IT DOESN'T CONTINUE TO TREND UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20023646 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THE PATIENT HAD GASTROINTESTINAL BLEEDING (GI BLEED). THE ISSUE WAS SUCCESSFULLY MANAGED BY TURNING OFF HEPARIN AND REMOVING IT FROM THE PURGE. THE PATIENT WAS SUCCESSFULLY WEANED AND THE DEVICE EXPLANTED. THE PATIENT SURVIVED THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20017058 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT IN ST ELEVATION MYOCARDIAL INFARCTION WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED WHILE ON IMPELLA CP SUPPORT, THE PATIENT LOST PULSES IN THE IMPELLA LEG. THE PATIENT WAS MONITORED FOR A POSSIBLE FEMORAL TO FEMORAL BYPASS. PRIOR TO PERFORMING FEMORAL TO FEMORAL BYPASS FOR THE LIMB ISCHEMIA, THE PATIENT BECAME SEPTIC AND THE MEDICAL TEAM MADE THE DECISION TO WEAN AND REMOVE THE IMPELLA CP DUE TO THE SEPSIS.

  Patient problems: Ischemia; Sepsis

  MAUDE report 20016418 ↗
• InjuryAug 21, 2024Positioning Failure; Positioning Failure

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. DURING THE IMPELLA CP IMPLANT, THE PATIENT WAS SHOCKED MULTIPLE TIMES FOR SYMPTOMATIC VENTRICULAR TACHYCARDIA (VT). THE BEDSIDE ECHOCARDIOGRAM INDICATED THE INLET-TO-VALVE DEPTH OF 2.8CM WITH THE PIGTAIL DIRECTED TOWARD MITRAL VALVULAR STRUCTURES. THE PATIENT WAS STILL BEING TREATED FOR BOUTS OF VT. THE STAFF APPLIED A FEMOSTOP FOR BLEEDING. THE FEMOSTOP WAS TAKEN OFF AS BLEEDING RESOLVED. THE PATIENT REMAINED ON IMPELLA SUPPORT AND WAS SUCCESSFULLY WEANED.

  Patient problems: Cardiac Arrest; Tachycardia

  MAUDE report 20013694 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED THAT A PATIENT WITH KNOWN CORONARY ARTERY DISEASE (CAD) WAS PRESENTED TO THE MEDICAL FACILITY WITH INCREASING CHEST PAINS AND ST ELEVATION MYOCARDIAL INFARCTION (STEMI). A CHEST X-RAY (CXR) REVEALED A PULMONARY EDEMA AND SEVERE LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION BETWEEN TWO (2) SEPARATE ANEURYSMAL AREAS. THE DECISION WAS MADE TO IMPLANT THE IMPELLA DEVICE. GROIN SITE BLEEDING WAS IDENTIFIED. THE SITE WAS DRESSED, AND ANGLE MATCHING TECHNIQUE WAS UTILIZED TO RESOLVE THIS ISSUE. IT WAS REPORTED THAT THE PATIENT¿S URINE WAS DARK RED IN COLOR AND A LARGE HEMATOMA WAS OBSERVED AT THE RIGHT RADIAL ANGIO ACCESS POINT. IT WAS REPORTED THAT THE IMPELLA DEVICE WAS REPOSITIONED TO MANAGE HEMOLYSIS AND MANUAL PRESSURE WAS HELD AT ACCESS SITE TO MANAGE THESE ACCESS SITE BLEEDING. HEPARIN WAS HELD AS THE PATIENT SUFFERED FROM A GASTROINTESTINAL (GI) BLEED AND RESTARTED AS THE GI BLEED IMPROVED. WEANING WAS SUCCESSFUL, AND THE DEVICE WAS EXPLANTED. THE PROCEDURAL OUTCOME IS THE PATIENT SURVIVED SURGERY.

  Patient problems: Hematoma; Hemolysis; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20012437 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT, THE PATIENT EXPERIENCED BRAIN BLEED. SYSTEMATIC HEPARIN WAS REMOVED, AND THE PHYSICIAN INQUIRED ABOUT REMOVAL OF HEPARIN IN PURGE AS WELL. THE PATIENT CONTINUED ON SUPPORT UNTIL THE DEVICE WAS SUCCESSFULLY WEANED.

  Patient problems: Hemorrhagic Stroke

  MAUDE report 20009881 ↗
• MalfunctionAug 20, 2024Positioning Failure; Positioning Failure

  THE USER FACILITY REPORTED A 57-YEAR-OLD FEMALE ON IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THERE WERE MULTIPLE ATTEMPTS TO REPOSITION PUMP AWAY FROM MITRIAL VALVE WITH ECHO AND UNDER FLUORO BUT THEY WERE UNSUCCESSFUL. THE PATIENT WAS ON 2.5 OF DOBUTAMINE SO IT WAS DECIDED TO REMOVE THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20008835 ↗
• InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT THE PATIENT SOME VENTRICULAR TACHYCARDIA OVERNIGHT. AMIO AND LIDO DRIPS WERE BEGUN FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Tachycardia

  MAUDE report 20006092 ↗
• InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT, THE RIGHT FOOT WELL PERFUSED DESPITE NO PULSES. TWO DAYS LATER, THE PATIENT HAD SIGNIFICANT BLEEDING OVERNIGHT AT THE IMPELLA/GROIN SITE. THE PATIENT IS GETTING TRANSFUSED. THE PATIENT WAS FOUND TO HAVE THE VENOUS SHEATH ALMOST OUT AND KINKED CLEARLY CAUSING THE BLEED. THE PHYSICIAN REFLOATED THE SHEATH WHICH SEALED THE GROIN AND THE IMPELLA WAS EXPLANTED. THE PATIENT SURVIVED THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ischemia

  MAUDE report 20005632 ↗
• InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINANT REPORTED THAT THE PATIENT WAS ATTEMPTING TO BE PLACED ON IMPELLA CP DUE TO THE NON-ST ELEVATED MYOCARDIAL INFARCTION, CATH SHOWED 90% CALCIFIED LEFT MAIN, 95% OSTIAL LEFT ANTERIOR DESCENDING, 85% CIRCUMFLEX, 99% MID RIGHT CORONARY ARTERY. CHRONIC KIDNEY DISEASE CREAT. 1.96, HYPERTENSION, CORONARY ARTERY DISEASE, HEART FAILURE, EJECTION FRACTION 20%, RENAL INSUFFICIENCY AND SURGICAL TURNDOWN. THE PATIENT'S PRIMARY INDICATION WAS NOTED AS HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION. WHILE ON SUPPORT, ON (B)(6) 2021, THE COMPLAINANT REPORTED THE PATIENT HAD A SMALL HEMATOMA NOTED IN CATH LAB AFTER THE PEEL AWAY SHEATH REMOVED, AND REPOSITIONING SHEATH PLACED. PERCLOSE SUTURES WERE TIGHTENED, PRESSURE WAS HELD, AND FEMSTOP ADDED. STANDARD CARE WAS PRESENTED TO THE PATIENT. STANDARD CARE IS NOT MEDICAL INTERVENTION. WHILE ON SUPPORT, ON (B)(6) 2021, THE COMPLAINANT REPORTED THE TREATMENT IS MOVING TOWARDS SEPSIS, WHITE BLOOD COUNT¿S 8.4, LOW GRADE TEMP 99 ALL DAY.

  Patient problems: Hematoma; Sepsis

  MAUDE report 20005237 ↗
• InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THE PATIENT HAD INCONSISTENT PEDAL PULSES DUE TO A 14 FRENCH OSCAR SHEATH STILL IN PLACE FROM THE IMPLANTING MEDICAL PROFESSIONAL. THE SIDE PORT OF THE SHEATH WAS USED TO PLACE A FEMOROFEMORAL BYPASS. IT WAS REPORTED THAT THE PATIENT WAS SEPTIC. THE PATIENT WAS SUCCESSFULLY WEANED FROM THE IMPELLA CP AND THE DEVICE WAS EXPLANTED. THE PATIENT SURVIVED THE PROCEDURE.

  Patient problems: Ischemia; Sepsis

  MAUDE report 20004868 ↗
• InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINANT REPORTED THE PATIENT WAS ON IMPELLA CP SUPPORT DUE TO HIGH-RISK VENTRICULAR TACHYCARDIA ABLATION. WHILE ON SUPPORT PEEL AWAY SHEATH DEEP IN VENTRICLE, GROIN OOZE, NO PULSATILITY, HEMOLYZED LABS, AND BLOODY URINE WAS NOTED. STICK ANGLE WAS BUILT UP AND SECURED, AND PEEL AWAY SHEATH WAS REPOSITIONED; THEREFORE, ACCESS SITE BLEEDING, AND POSITIONING ISSUE IS NOT REPORTABLE. REPORTABLE DUE TO HEMOLYSIS.

  Patient problems: Hemolysis; Ischemia

  MAUDE report 20004079 ↗
• InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT WHILE THE PATIENT WAS ON IMPELLA CP SUPPORT, THE PATIENT EXPERIENCED ECTOPY DUE TO A SMALL LEFT VENTRICLE. THE PHYSICIAN PULLED THE IMPELLA BACK SLIGHTLY AND LOWERED THE P LEVEL OF THE PUMP TO P5 TO RESOLVE THE ECTOPY. IT WAS ALSO REPORTED THAT THE PATIENT HAD OOZING AT THE IMPELLA ACCESS SITE. INTEGRILIN WAS DISCONTINUED DUE TO THE ONGOING BLEEDING AND A SMALL HEMATOMA AT THE IMPELLA ACCESS SITE. THE DRESSINGS AT THE IMPELLA ACCESS SITE WERE CHANGED AND ANGLE MATCHED, AND HEMOSTASIS WAS ACHIEVED. THE PATIENT REMAINED ON IMPELLA SUPPORT AND WAS SUCCESSFULLY WEANED.

  Patient problems: Ectopic Heartbeat; Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20002871 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT, THERE WAS A HEMATOMA AT THE ACCESS SITE, WHICH WAS RESOLVED. ALSO, SYSTEMIC HEPARIN WAS TO BE RESUMED PENDING RESOLUTION OF THE GI BLEED REQUIRING TRANSFUSION OF TWO (2) UNITS OF PACKED RED BLOOD CELLS.

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

  MAUDE report 19993705 ↗

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-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-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-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.