BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24327611 · Received February 12, 2026

    Report

    Report Number
    1220648-2026-03074
    Event Type
    Death
    Date Received
    February 12, 2026
    Date of Event
    February 5, 2026
    Report Date
    April 2, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION: D1 BRAND NAME CHANGED. H6 COMPONENT CODE CHANGED TO G07003. THE INVESTIGATION FOR HEMOLYSIS/MECHANICAL INTERACTION WITH BLOOD HAS BEEN COMPLETED. THE CAUSE OF THE HEMOLYSIS ISSUE COULD NOT BE DETERMINED WITHOUT THE RETURNED PRODUCT FOR INVESTIGATION AND SUFFICIENT CLINICAL DETAILS, INCLUDING DATA LOG. THE INVESTIGATION FOR HIGH OR SATURATED PUMP FLOW HAS BEEN COMPLETED. THE CAUSE OF THE HIGH OR SATURATED PUMP FLOW ISSUE COULD NOT BE DETERMINED WITHOUT THE RETURNED PRODUCT FOR INVESTIGATION AND SUFFICIENT CLINICAL DETAILS, INCLUDING DATA LOG. THE INVESTIGATION FOR THE HEMORRHAGE/BLOOD LOSS/BLEEDING HAS BEEN COMPLETED. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    SECTION E INITIAL REPORTER INFORMATION WAS ADDED SINCE IT WAS OMITTED FROM THE INITIAL.

    Additional Manufacturer Narrative · 0

    D2 (DATE OF DEATH) HAS BEEN OMITTED FROM THE INITIAL MEDWATCH. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER; THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    AN IMPELLA CP WAS PLACED VIA THE RIGHT FEMORAL ARTERY TO SUPPORT A 69-YEAR-OLD MALE PATIENT ADMITTED IN WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, IN SCAI STAGE D SHOCK. THERE WAS NO OTHER MEDICAL HISTORY SHARED. ON DAY THREE OF CP SUPPORT, THE PATIENT WAS BRIDGED TO IMPELLA 5.5 VIA RIGHT AXILLARY ARTERY FOR BRIDGE TO HEART TRANSPLANT. ON DAY TWO OF 5.5 SUPPORT, THE PATIENT EXPERIENCED NEUROLOGICAL CHANGES AND HEAD COMPUTED TOMOGRAPHY (CT) REVEALED NO FINDINGS. ON DAY FOUR OF 5.5 SUPPORT, THE PATIENT'S URINE WAS RED. THE PATIENT WAS ALSO ON VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO) AND THERE WAS CONCERN THIS COULD BE A CONTRIBUTING FACTOR. AN UNKNOWN AMOUNT OF BLOOD PRODUCTS WERE TRANSFUSED. THE PUMP FLOW INCREASED FROM 2.5L TO 3L. ON DAY EIGHT OF 5.5 SUPPORT, CARE WAS WITHDRAWN AND THE PUMP EXPLANTED, AND THE PATIENT EXPIRED. HEMOLYSIS AND DEATH ARE KNOWN RISKS ASSOCIATED WITH IMPELLA CP AND IMPELLA 5.5 AS DESCRIBED IN THE INSTRUCTIONS FOR USE. THIS IMPELLA 5.5 DEVICE REPORT IS ONE OF TWO DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER AS NOTED IN SECTION H10 FOR THE MEDICAL DEVICE REPORT ON THE ORIGINAL IMPELLA 5.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388203 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026804473 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Death