BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24324721 · Received February 12, 2026

    Report

    Report Number
    1220648-2026-03044
    Event Type
    Injury
    Date Received
    February 12, 2026
    Date of Event
    December 9, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    H6 MEDICAL DEVICE PROBLEM CODE WAS ERRONEOUSLY ENTERED WITH A140501 AND HAS BEEN UPDATE TO INCLUDE A01.

    Additional Manufacturer Narrative · 0

    B1: ADDED PRODUCT PROBLEM, THIS WAS OMITTED IN THE INITIAL REPORT IN ERROR.

    Description of Event or Problem · 0

    THE PATIENT IS A 74-YEAR-OLD INDIVIDUAL WITH AN ACUTE MYOCARDIAL INFARCTION SUPPORTED BY AN IMPELLA CP WITH SMARTASSIST. DURING SUPPORT, A "MOTOR CURRENT HIGH" ALARM OCCURRED. SHORTLY AFTERWARDS, THE IMPELLA STOPPED, AND A RETROGRADE FLOW ALARM WAS TRIGGERED. ATTEMPTS TO RESTART OR RAMP UP THE PUMP WERE UNSUCCESSFUL, AND THE CLINICAL TEAM ELECTED TO REMOVE THE PUMP. THE PATIENT ALSO UNDERWENT A MITRACLIP PROCEDURE DURING WHICH A SENTINEL CEREBRAL PROTECTION DEVICE WAS USED. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT DEVELOPED A RIGHT RADIAL HEMATOMA AT THE ARTERIAL ACCESS SITE. THIS EVENT WAS DETERMINED TO BE UNRELATED TO THE IMPELLA DEVICE ALTHOUH ANTICOAGULATION FOR IMPELLA MIGHT HAVE INFLUENCED THE EVENT. THE CLINICAL TEAM MANAGED THE HEMATOMA BY APPLYING TWO TR BANDS TO ACHIEVE HEMOSTASIS. NO ADDITIONAL IMPELLA-RELATED CONCERNS OR DEVICE ISSUES WERE REPORTED FOR THE REMAINDER OF THE PROCEDURE. THE IMPELLA CP IS CONSERVATIVELY CODED FOR HEMATOMA ALTHOUGH THIS IS TO BE ATTRIBUTED TO THE PROCEDURE USING RADIAL ACCESS. NEVERTHELESS, IMPELLA REQUIRED ANTICOAGULATION AND THIS MIGHT HAVE CONTRIBUTED TO AN ELEVATED RISK FOR BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142683 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 PUMP 381 PUMP SET (US) 2026776817 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1