BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 24306178 · Received February 10, 2026

    Report

    Report Number
    1220648-2026-02783
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Date of Event
    February 4, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    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

    ADDITIONALLY IT WAS REPORTED THAT THE ALARMS WERE NOT A SUSTAINED ISSUE, MORE INTERMITTENT. AND THE TEAM DID NOT WISH TO TROUBLESHOOT ANY FURTHER BECAUSE PATIENT WAS SCHEDULED FOR EXPLANT THE FOLLOWING DAY. E4 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT.

    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

    SECTION D1 BRAND NAME CORRECTED. H6 MEDICAL DEVICE PROBLEM CODES A140508 WAS INADVERTENTLY OMITTED. LOW OR BLOCKED PUMP FLOW: DUE TO A LACK OF SUFFICIENT DATA LOGS DURING THE TIME OF THE REPORTED EVENT AND NO PRODUCT RETURNED, THE CAUSE OF THE LOW OR BLOCKED PUMP FLOW CANNOT BE ESTABLISHED. PLACEMENT SIGNAL ISSUE: DUE TO A LACK OF SUFFICIENT DATA LOGS DURING THE TIME OF THE REPORTED EVENT AND NO PRODUCT RETURNED, THE CAUSE OF THE PLACEMENT SIGNAL ISSUE CANNOT BE ESTABLISHED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT WAS IMPLANTED WITH AN IMPELLA 5.5 FOR MECHANICAL CIRCULATORY SUPPORT. THE DEVICE EXHIBITED A LOW PLACEMENT SIGNAL WITH ASSOCIATED SUCTION ALARMS. THE PLACEMENT SIGNAL WAS NO LONGER CORRELATING WITH THE HEMODYNAMIC MONITOR. RECALIBRATION OF THE AORTIC PRESSURE WAS PERFORMED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED: THERE WERE CONCERNS REGARDING THE PLACEMENT OF THE SIGNAL ALARMS. RECALIBRATION WAS PERFORMED, WHICH TEMPORARILY RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309819 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026765805 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1