BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 23770087 · Received December 10, 2025

    Report

    Report Number
    1220648-2025-48907
    Event Type
    Injury
    Date Received
    December 10, 2025
    Date of Event
    November 12, 2025
    Report Date
    January 22, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY NO PRODUCT WAS RETURNED. TACHYCARDIA: IN ORDER TO MAKE A CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS OUTLINED IN ES2023-0158 WOULD HAVE TO BE PROVIDED. THE CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. ASAE/HEMATOMA: RT AXILLARY HEMATOMA. THE CAUSE OF THE HEMATOMA WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE IN WRONG POSITION: THE CAUSE OF THE POSITIONING ISSUE WAS DETERMINED TO BE AN ADVERSE EVENT RELATED TO THE ANATOMY OF THE PATIENT DUE TO SMALLER CAVITY AND HYPER-DYNAMIC LV. DEVICE HISTORY LOT DEVICE LOT: 1973999 DEVICE HISTORY BATCH SUBCOMPONENT LOT: N/A DEVICE HISTORY REVIEW DEVICE (SN: (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT A 50 YR OLD MALE WAS IMPLANTED WITH AN IMPELLA 5.5 FOR CARDIAC ARREST TO SUPPORT PERCUTANEOUS CORONARY INTERVENTION. IT WAS REPORTED THAT PATIENT HAD VENTRICULAR TACHYCARDIA WHICH ATTRIBUTED TO IMPELLA HITTING VENTRICULAR WALL DUE TO SMALLER CAVITY AND HYPER-DYNAMIC LEFT VENTRICLE. RIGHT AXILLARY HEMATOMA WAS ALSO NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2042092 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026739573 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention