BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA 5.5

    MDR report key: 23381445 · Received October 24, 2025

    Report

    Report Number
    1220648-2025-47793
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    September 13, 2025
    Report Date
    January 6, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502013276
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PRODUCT OR LOGS RETURNED FOR EVALUATION. HIGH PURGE PRESSURE: CLINICAL DETAILS NOTED THAT PUMP UNDERWENT LYSIS PROTOCOL DUE TO HIGH PURGE PRESSURE. NO ADDITIONAL DETAILS WERE PROVIDED. THE CAUSE OF THE HIGH PURGE PRESSURE COULD NOT BE DETERMINED AS NO PRODUCTS OR LOGS WERE RETURNED FOR EVALUATION AND CLINICAL DETAILS WERE PROVIDED. OPTICAL SIGNAL ISSUE: CLINICAL DETAILS NOTED THAT AIC WAS NOT DISPLAYING PS OR LV CURVES OR VALUES. PUMP POSITION WAS CONFIRMED, PUMP WAS NOT REPLACED. NO ADDITIONAL DETAILS WERE PROVIDED. THE CAUSE OF THE OPTICAL SIGNAL ISSUE COULD NOT BE DETERMINED AS NO PRODUCT OR LOGS WERE RETURNED FOR EVALUATION AND LIMITED CLINICAL DETAILS WERE PROVIDED. DEVICE HISTORY LOT: DEVICE LOT: 1945136. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW PUMP SN (B)(6) PASSED ALL POST-STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS NOT BEEN RECEIVED FROM THE CUSTOMER. THEREFORE, INVESTIGATION OF THE DEVICE IS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED PATIENT HAD A 5.5 PUMP SUPPORTING THE PATIENT ADMITTED IN WITH CGS AND CARDIOMYOPATHY. THE PUMP WAS SUPPORTING WHILE LEFT VENTRICULAR ASSIST DEVICE BEING CONSIDERED. THE TEAM DID OBSERVE HIGH PP AND GAVE LYTIC TO RESOLVE, AND ADDITIONALLY THERE WAS OPTICAL SIGNAL LOSS. THE MALFUNCTIONS DID NOT CAUSE ANY HARM OR INJURY. PUMP REMAINED ON UNTIL WEAN AND EXPLANT AFTER 32 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2172896 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026711230 00813502013276

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female