BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24542695 · Received March 9, 2026

    Report

    Report Number
    1220648-2026-04714
    Event Type
    Injury
    Date Received
    March 9, 2026
    Date of Event
    October 24, 2025
    Report Date
    April 25, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION: D1 BRAND NAME UPDATED. H6 COMPONENT CODE CHANGED TO G07003. THE INVESTIGATION FOR THE EPISTAXIS/MAJOR BLEED HAS BEEN COMPLETED. NO PRODUCT WAS RETURNED. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    73-YEAR-OLD WITH HISTORY OF AFIB WITH RVR AND ICM VS NICM, PRESENTED WITH ACUTE ON CHRONIC DECOMPENSATED HF. (B)(6) IMPELLA 5.5 IMPLANTED VIA RIGHT AXILLARY ARTERY WITHOUT INCIDENT WITH REMOVAL OF FEMORAL IABP. (B)(6) REPOSITIONING NOT ASSOCIATED WITH AN ALARM. DEVICE FUNCTIONING WELL. (B)(6) EPISTAXIS NOTED, HEPARIN INFUSION HELD. 11/10 NOTED TO HAVE RETROPERITONEAL BLEED FROM PRIOR IABP PLACEMENT (UNRELATED TO IMPELLA INSERTION SITE). (B)(6) DEVICE WEANED AND EXPLANTED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301738 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026744008 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1