BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24413124 · Received February 23, 2026

    Report

    Report Number
    1220648-2026-03747
    Event Type
    Death
    Date Received
    February 23, 2026
    Date of Event
    February 13, 2026
    Report Date
    March 25, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 CHANGED. THE INVESTIGATION FOR ISCHEMIA HAS BEEN COMPLETED. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    AN IMPELLA CP WAS INSERTED VIA LEFT FEMORAL ARTERY IN A 64-YEAR-OLD FEMALE WHO WAS ADMITTED FOR CARDIOMYOPATHY. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SCAI STAGE E. THE PATIENT RECEIVED SUPPORT FROM THE CP WHILE IN THE INTENSIVE CARE UNIT. ON DAY 2 OF SUPPORT, THE PATIENT'S LEFT FOOT PULSES WERE NON-DOPPLERABLE, AND CAPILLARY REFILL GREATER THAN 3 SECONDS. THE PATIENT WAS ALSO ON LEVOPHED. ON DAY 6 OF SUPPORT, CARE WAS WITHDRAWN AND THE PATIENT EXPIRED. LIMB ISCHEMIA AND DEATH ARE KNOWN RISKS ASSOCIATED WITH IMPELLA CP AS DESCRIBED IN THE INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116674 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026761451 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Death