BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 24468771 · Received February 27, 2026

    Report

    Report Number
    1220648-2026-04189
    Event Type
    Malfunction
    Date Received
    February 27, 2026
    Date of Event
    February 17, 2026
    Report Date
    March 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION HAS BEEN PROVIDED IN D1 BRAND NAME. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF PURGE PRESSURE HIGH WAS UNABLE TO BE DETERMINED AS LIMITED CLINICAL DETAILS WERE PROVIDED AND NO PRODUCT WAS RETURNED FOR REVIEW.

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION: D6B EXPLANT DATE ADDED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT WAS IMPLANTED WITH AN IMPELLA 5.5 VIA RIGHT SURGICAL INNOMINATE ARTERY FOR MECHANICAL CIRCULATORY SUPPORT. A NURSE REPORTED A HIGH PURGE PRESSURE/PURGE SYSTEM BLOCKED ALARM AND CHECKED ALL TUBING AND NO KINKS, LOOPS OR RESTRAINTS WERE NOTED. THE PATIENT WAS ON BIVALIRUDIN AND WAS THERAPEUTIC FOR DAYS. NO CHANGES IN MOTOR CURRENT WERE NOTICED BY THE NURSE. IT HAS BEEN AND WAS ABOUT 270/211 ON P5 WITH FLOWS OF 3.5. THE MEDICAL OFFICE IS REACHING OUT TO RESIDENT WITH PROTOCOL AND THEY PLAN TO START TISSUE PLASMINOGEN ACTIVATOR (TPA) SHORTLY. ADDITIONAL INFORMATION WAS RECEIVED. THE REGISTERED NURSE CALLED ABOUT THE ABOVE ALARM (PURGE SYSTEM BLOCKED) AND NOTED THAT THEY ARE CURRENTLY RUNNING TPA IN THE PURGE. THE PURGE FLOW IS STILL LESS THAN ONE. THE PURGE PRESSURE ALARM RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304961 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026801120 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1