BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 23988773 · Received January 7, 2026

    Report

    Report Number
    1220648-2026-00210
    Event Type
    Injury
    Date Received
    January 7, 2026
    Date of Event
    December 19, 2025
    Report Date
    January 27, 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
    US
    Reporter Occupation
    PHYSICIAN
    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

    INVESTIGATION SUMMARY: THE PUMP WAS NOT RETURNED FOR INVESTIGATION. DATA LOG SHOWS SEVERAL PLACEMENT SIGNAL LOW ALARMS ON 18-DEC. PLACEMENT SIGNAL WAS SEEN FLUCTUATING AT THE START OF THE CASE AND SHOWED AN OVERALL DETERIORATING TREND WITH HIGH IN AMPLITUDE. NO ISSUE WAS NOTED ON THE 5S OPTICAL SIGNAL PARAMETER. CLINICAL SYMPTOM (HEMATURIA): THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. PLACEMENT SIGNAL ISSUE: THE CAUSE OF THE PLACEMENT SIGNAL ISSUE WAS NOT DETERMINED WITHOUT RETURNED PRODUCT INVESTIGATION AND SUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT: 1983652. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: THE COMPLAINT PUMP S/N (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THE PATIENT OBSERVED TO HAVE A PINK/RED TINGED URINE NOTED IN FOLEY CATHETER UPON ARRIVAL TO THE INTENSIVE CARE UNIT (ICU), AND IT WAS UNCLEAR OF IF THIS WAS PRESENT PRIOR TO IMPELLA INSERTION. AND IN ADDITION IT WAS REPORTED THAT THE PLACEMENT SIGNAL WAS LOW. THE PATIENT WAS REPORTED TO HAVE SURVIVED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53528 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 IMPELLA CP 2026781986 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention