Impella 0052-0011Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813502010015), received between Mar 8, 2026 and May 1, 2026 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Fluid/Blood Leak; Patient Device Interaction Problem

  AN IMPELLA 5.5 DEVICE WAS INSERTED VIA THE LEFT AXILLARY ARTERY IN A 63-YEAR-OLD MALE PATIENT WITH CARDIOMYOPATHY AND A HISTORY OF KNOWN CORONARY ARTERY DISEASE. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE D. LEAKING WAS OBSERVED FROM BETWEEN THE 10MM GELWEAVE GRAFT AND 23F SHEATH DESPITE BEING LOCKED WITH GRAFT LOCKS AND TWO ADDITIONAL HEAVY TIES. THE PATIENT SURVIVED TO EXPLANT. BLEEDING MAY BE ASSOCIATED WITH ACCESS-SITE COMPLICATIONS AND GRAFT INTERFACE ISSUES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25057328 ↗
• InjuryApr 1, 2026Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  AN IMPELLA 5.5 DEVICE WAS INSERTED VIA THE RIGHT AXILLARY ARTERY IN A 34-YEAR-OLD FEMALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), SCAI SHOCK STAGE E. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. A GRAFT WAS SEWN ONTO THE RIGHT AXILLARY ARTERY, AND THE SHEATH AND GRAFT WERE SECURED IN PLACE. DURING THE PROCEDURE, THE SURGEON ATTEMPTED TO ADVANCE A 0.035-INCH J-WIRE BUT WAS UNABLE TO PASS IT THROUGH THE ANASTOMOSIS. THE ANASTOMOSIS WAS TAKEN DOWN, AT WHICH TIME DISSECTION OF THE AXILLARY ARTERY WAS IDENTIFIED. A PATCH WAS PLACED TO REPAIR THE ARTERY, AND A 10 MM GRAFT WAS SUBSEQUENTLY ANASTOMOSED TO THE PATCH. THE PATIENT REMAINED ON IMPELLA SUPPORT FOLLOWING THE REPAIR. THE REPORTED VASCULAR DISSECTION IS CONSISTENT WITH ACCESS-RELATED ARTERIAL INJURY DURING SURGICAL MANIPULATION AND GRAFT ANASTOMOSIS IN THE SETTING OF URGENT MECHANICAL CIRCULATORY SUPPORT PLACEMENT

  Patient problems: Vascular Dissection

  MAUDE report 24754145 ↗
• DeathMar 8, 2026Adverse Event Without Identified Device or Use Problem

  AN IMPELLA 5.5 DEVICE WAS INSERTED VIA THE RIGHT AXILLARY ARTERY IN A 64 YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), SCAI SHOCK STAGE D, WITH A HISTORY OF KNOWN CORONARY ARTERY DISEASE (CAD) AND RENAL INSUFFICIENCY. THE PATIENT UNDERWENT IMPELLA 5.5 PLACEMENT IN THE OPERATING ROOM, AND A JP DRAIN WAS PLACED, WHICH DEMONSTRATED ONGOING DRAINAGE. THE PATIENT RECEIVED 1 UNIT OF PACKED RED BLOOD CELLS (PRBCS). THE ANTICOAGULATION LEVEL WAS FOUND TO BE HIGH, PROMPTING THE CARE TEAM TO STOP HEPARIN, AFTER WHICH THE BLEEDING STOPPED. HEPARIN WAS LATER RESTARTED AT A LOWER DOSE. THE PATIENT REMAINED ON SUPPORT. THE REPORTED MAJOR BLEED REQUIRING BLOOD TRANSFUSION AND HEMOSTASIS IS CONSISTENT WITH ACCESS-SITE COMPLICATIONS AND THE ANTICOAGULATION/PURGE REQUIREMENTS ASSOCIATED WITH IMPELLA SUPPORT. THE BLEEDING WAS RESOLVED WITH STANDARD INTERVENTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24542076 ↗