BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 23936019 · Received December 31, 2025

    Report

    Report Number
    1220648-2025-49675
    Event Type
    Injury
    Date Received
    December 31, 2025
    Date of Event
    December 11, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED CODE A01 BASED ON INFORMATION IN THE COMPLAINT FILE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY- MECHANICAL INTERACTION WITH BLOOD (HEMOLYSIS): THE CAUSE OF THE HEMOLYSIS WAS NOT DETERMINED DUE TO LACK OF CONCLUSIVE EVIDENCE AS THE PUMP WAS MENTIONED TO BE IN GOOD POSITION. DEVICE IN WRONG POSITION: THE CAUSE OF THE POSITIONING ISSUE WAS NOT DETERMINED DUE TO LACK OF CLINICAL INFORMATION. DEVICE HISTORY LOT - DEVICE LOT: 1934630. DEVICE HISTORY BATCH- SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW- THE COMPLAINT PUMP S/N (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    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.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT WAS IMPLANTED WITH AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. ON THE FIRST DAY OF SUPPORT, IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEMOLYSIS. THE IMPELLA WAS REPOSITIONED AND SUBSEQUENTLY THE HEMOLYSIS RESOLVED. THE DEVICE WAS EXPLANTED SUCCESSFULLY AFTER WEANING. THE EXPLANT WAS NOT CONSIDERED PREMATURE AND WAS UNRELATED TO THE REPORTED COMPLICATION. THE PATIENT'S OUTCOME AT THE TIME OF EXPLANT WAS SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286190 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026681982 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention