BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 23630747 · Received November 24, 2025

    Report

    Report Number
    1220648-2025-48574
    Event Type
    Injury
    Date Received
    November 24, 2025
    Date of Event
    October 29, 2025
    Report Date
    January 5, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012200
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED. AS NOTED IN THE IMPELLA INSTRUCTIONS FOR USE: IMPELLA CP WITH SMARTASSIST SYSTEM. SECTION: POTENTIAL ADVERSE EVENTS (UNITED STATES). ¿ACUTE RENAL DYSFUNCTION, AORTIC VALVE INJURY, BLEEDING, CARDIOGENIC SHOCK, CEREBRAL VASCULAR ACCIDENT/STROKE, DEATH, HEMOLYSIS, LIMB ISCHEMIA, MYOCARDIAL INFARCTION, RENAL FAILURE, THROMBOCYTOPENIA AND CARDIAC OR VASCULAR INJURY (INCLUDING VENTRICULAR PERFORATION).¿

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PRODUCT WAS RETURNED FOR INVESTIGATION. ISCHEMIA: IN ORDER TO MAKE A ROOT CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS OUTLINED IN ES2023-0158 WOULD HAVE TO BE PROVIDED. THE ROOT CAUSE OF THE ISCHEMIA WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT: 1921936. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: DEVICE WITH SN: (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA CP EXPERIENCED VERY POOR PERIPHERAL PERFUSION TO BOTH LOWER LIMBS. THE IMPELLA CP WAS EXPLANTED DUE TO SEVERELY COMPROMISED LOWER LIMB PERFUSION. A CENTRAL EXTRACORPOREAL MEMBRANE OXYGENATION WAS SUBSEQUENTLY INITIATED. THE PATIENT WAS STABLE ON IMPELLA CP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2310564 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026674404 00813502012200

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention