BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 23956936 · Received January 5, 2026

    Report

    Report Number
    1220648-2026-00093
    Event Type
    Injury
    Date Received
    January 5, 2026
    Date of Event
    December 25, 2025
    Report Date
    February 5, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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: PRIMING PROBLEM/USE AGAINST LABELING: CLINICAL REPORTED PRIOR TO DEVICE START, TEAM FORGOT TO CONNECT PUMP TO PURGE LINE AND PUMP WAS NOT PRIMED PRIOR TO ENTERING BODY. THE CAUSE OF THIS ISSUE WAS DETERMINED TO BE USE RELATED AS EVIDENCED BY CLINICAL DETAILS MENTIONING PUMP INSERTION WITHOUT PRIMING. HEMODYNAMIC INSTABILITY: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT : 1994175. 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

    IT WAS REPORTED THAT WHILE IMPLANTING AN IMPELLA CP THE TEAM FORGOT TO CONNECT TO THE PURGE LINE AND PRIME THE PUMP. A NEW IMPELLA CP WAS PREPARED AND IMPLANTED CORRECTLY. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17172 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026775458 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female