BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24226547 · Received January 30, 2026

    Report

    Report Number
    1220648-2026-02009
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    January 23, 2026
    Report Date
    January 30, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 CODE A140508 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    E4 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT. THE INVESTIGATION OF THE REPORTED FAILURE MODE HAS BEEN COMPLETED. NO PRODUCT WAS RECEIVED FOR EVALUATION. LOW PUMP FLOW: THE CAUSE OF THE ISSUE WAS NOT DETERMINED AS NO PRODUCT OR LOGS WERE RETURNED FOR ANALYSIS AND LIMITED CLINICAL INFORMATION WAS PROVIDED. DEVICE IN WRONG POSITION: THE CAUSE OF THE ISSUE WAS NOT ESTABLISHED AS LIMITED CLINICAL INFORMATION WAS PROVIDED ON HOW PUMP BECAME MISPOSITIONED. DEVICE HISTORY REVIEW: THE DEVICE 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 A 76-YEAR-OLD FEMALE ON AN IMPELLA 5.5 DUE TO CARDIOGENIC SHOCK. DURING SUPPORT, THE PUMP NEEDED REPOSITIONING AFTER PATIENT WAS BROUGHT BACK TO OR DUE TO LOW FLOWS. A TRANSESOPHAGEAL ECHO (TEE) SHOWED THE PUMP ON THE LATERAL WALL, AND THE SURGEON WAS ABLE TO REPOSITION INTO APPROPRIATE MID-VENTRICULAR SPACE. THE PATIENT REMAINED STABLE. THE PATIENT WAS SUCCESSFULLY EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288208 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 WITH SMARTASSIST S2 SET, US 2026775944 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female