BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 23927038 · Received December 30, 2025

    Report

    Report Number
    1220648-2025-49559
    Event Type
    Death
    Date Received
    December 30, 2025
    Date of Event
    December 4, 2025
    Report Date
    December 30, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011944
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY- THE CAUSE OF THE OPTICAL SENSOR ISSUE WAS DETERMINED TO MOST LIKELY BE DUE TO THE PATIENT'S CONDITION. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT- DEVICE LOT : 1932120. DEVICE HISTORY BATCH- SUBCOMPONENT LOT : N/A. DEVICE HISTORY REVIEW- THE PUMP SN (B)(6) PASSED ALL THE POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT THERE HAD BEEN A DELAY WITH IMPELLA CONNECT, WHICH RENDERED IT INADEQUATE FOR LIVE SUPPORT DURING THE CASE. THE REPRESENTATIVE WAS ON A VIDEO CALL WITH THE ACCOUNT TO PROVIDE ASSISTANCE, BUT IMPELLA CONNECT DID NOT REFLECT THE REAL-TIME SITUATION. THE DATA WAS NOT CURRENT, AND THE TEAM EXPERIENCED IMPELLA PLACEMENT SIGNAL LOW ALARMS DURING A HYPOTENSIVE EPISODE THAT WERE NOT VISIBLE ON IMPELLA CONNECT, DESPITE THE SYSTEM DISPLAYING ¿LIVE¿ AND SWEEPING THROUGH THE WINDOW. VIDEO EVIDENCE SHOWED THE PATIENT IN A CRASHED STATE WITH NO OUTPUT, WHILE IMPELLA CONNECT CONTINUED TO DISPLAY A BLOOD PRESSURE OF 84/44, INACCURATELY INDICATING STABILITY. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2220489 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 IMPELLA CP 2026737677 00813502011944

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death| R