BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA CP

    MDR report key: 23935438 · Received December 31, 2025

    Report

    Report Number
    1220648-2025-49649
    Event Type
    Malfunction
    Date Received
    December 31, 2025
    Date of Event
    December 14, 2025
    Report Date
    January 28, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    813502012279
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PRODUCT RETURNED. DEVICE IN WRONG POSITION: THE CAUSE OF THE POSITIONING ISSUE WAS USE RELATED TO PATIENT MOVEMENT AS THE PATIENT BECAME CONFUSED AND PULLED OUT HIS IMPELLA CP. ASAE/MINOR BLEED: THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS USE RELATED TO PATIENT MOVEMENT AS THE ISSUE OCCURRED AFTER THE PATIENT BECAME CONFUSED AND PULLED OUT HIS IMPELLA CP. DEVICE HISTORY LOT: DEVICE LOT: 1961521. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: THE DEVICE (SN:(B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    A4 IS UNKNOWN. THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT WAS IMPLANTED WITH AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. ON SUPPORT DAY 2, IT WAS REPORTED THAT THE PATIENT BECAME CONFUSED AND PULLED AND REMOVED THE IMPELLA CP FROM THEIR BODY. MANUAL PRESSURE WAS HELD AT THE IMPELLA ACCESS SITE TO ACHIEVE HEMOSTASIS. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT'S OUTCOME AT THE TIME OF EXPLANT WAS SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2529621 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026731108 813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male