BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_IMPELLA CP

    MDR report key: 24568909 · Received March 11, 2026

    Report

    Report Number
    1220648-2026-05036
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    November 19, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 MEDICAL DEVICE PROBLEM CODE WAS UPDATED FROM A24 TO A01.

    Additional Manufacturer Narrative · 0

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    A 72-YEAR-OLD MAN HAD UNDERGONE IMPELLA CP SUPPORT TREATMENT FOR AMICS. HE WAS ALSO BEING SUPPORTED WITH VA ECMO. PROFUSE BLEEDING WAS NOTED FROM THE RIJ ECMO INSERTION SITE WHICH REQUIRED BLOOD TRANSFUSION. IMPELLA CP NOT IMPLICATED IN BLEEDING - THIS IS AN ECMO VENOUS CANNULA RELATED ISSUE, BUT EVENT IS CONSERVATIVELY REPORTED SINCE IMPELLA CP WAS IN PLACE AT TIME OF BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136066 UNK_IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648

    Patients

    Seq Age Sex Outcome Treatment
    1