BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24394171 · Received February 19, 2026

    Report

    Report Number
    1220648-2026-03613
    Event Type
    Injury
    Date Received
    February 19, 2026
    Date of Event
    December 31, 2025
    Report Date
    May 4, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4) INVESTIGATION SUMMARY ==> HEMODYNAMIC INSTABILITY: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. PRODUCT DAMAGE (CATHETER- TWIST, BENT, KINKED): THE ROOT CAUSE OF THE CATHETER KINK WAS PATIENT CONDITION RELATED OWING TO VESSEL ANATOMY BASED ON PROVIDED CLINICAL DETAILS. FAILURE TO ADVANCE: THE ROOT CAUSE OF THE FAILURE TO ADVANCE THE PUMP WAS PATIENT CONDITION RELATED DUE TO VESSEL ANATOMY BASED ON PROVIDED CLINICAL DETAILS. DEVICE HISTORY LOT ==> DEVICE LOT: 1964756 DEVICE HISTORY BATCH ==> SUBCOMPONENT LOT: N/A DEVICE HISTORY REVIEW ==> PUMP (B)(4) PASSED ALL POST-STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION HAS BEEN PROVIDED IN UDI (D4) WAS PREVIOUSLY ENTERED INCORRECTLY THE COMPLETE UDI HAS NOW BEEN PROVIDED. E1. ADDED/UPDATED ZIP CODE EXTENSION WAS OMITTED INFORMATION DURING INITIAL.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER; THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION: D4 SERIAL NUMBER AND UDI UPDATED D9 DEVICE RETURN DATE ADDED. DEVICE EVALUATION IS ONGOING.

    Description of Event or Problem · 0

    DURING INSERTING THE IMPELLA CP, THE PATIENT EXPERIENCED A PRODUCT DAMAGE ISSUE. THE MD TRIED TO ADVANCE THE PUMP BUT DUE TO ANATOMY IT WASN'T POSSIBLE AND THE CATHETER SHAFT WAS DAMAGED. THERE WERE NO PATIENT CONSEQUENCE AND DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321732 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 PUMP 381 PUMP SET (US) 2026736422 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1