BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24282734 · Received February 6, 2026

    Report

    Report Number
    1220648-2026-02480
    Event Type
    Injury
    Date Received
    February 6, 2026
    Date of Event
    December 5, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED: B5 BASED ON NEW ADDITIONAL INFORMATION RECEIVED. CORRECTED: D4 PRIMARY UDI NUMBER. 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.

    Additional Manufacturer Narrative · 0

    B5: ADDED UPDATED CLINICAL REVIEW. H6: OMITTED A141204 AND ADDED A141203.

    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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION INDICATES THAT THE STANDARD INTERVENTIONS WERE PERFORMED FOR RESTARTING THE PUMP. AFTER THE FAILED 3RD ATTEMPT TO RESTART THE PUMP, THE PUMP WAS REMOVED AND A NEW PUMP INSERTED. THE DEVICE IS AVAILABLE FOR RETURN AND A RETURN KIT IS NEEDED.

    Description of Event or Problem · 0

    AN IMPELLA CP DEVICE WAS INSERTED INTO THE LEFT FEMORAL ARTERY IN A 90-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY BYPASS GRAFT (CABG), CORONARY ARTERY DISEASE (CAD), PRESENTING IN SCAI STAGE A SHOCK, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT FOR A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, LEFT VENTRICLE (LV) ACCESS WAS OBTAINED WITH A PIGTAIL CATHETER AND THE IMPELLA WAS ADVANCED. THE DEVICE WAS UNABLE TO START DUE TO PUMP FAILURE MODE. TROUBLESHOOTING ATTEMPTS WERE MADE, BUT AFTER THE THIRD ATTEMPT TO START THE PUMP, THE IMPELLA WAS REMOVED AND EXCHANGED FOR A NEW IMPELLA CP. THE IMPELLA WILL BE CONSERVATIVELY REPORTED FOR HEMODYNAMIC INSTABILITY DUE TO TEMPORARY HEMODYNAMIC SUPPORT INTERRUPTION DURING THE EXCHANGE; HOWEVER, THE EXCHANGE WAS PERFORMED WITH NO CONSEQUENCE TO THE PATIENT AND SUPPORT.

    Description of Event or Problem · 0

    A (B)(6) MALE PATIENT UNDERWENT A HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION OF THE LEFT ANTERIOR DESCENDING ARTERY WITH THE DECISION FOR HEMODYNAMIC SUPPORT USING AN IMPELLA DEVICE. UPON IMPLANTATION, THE IMPELLA PUMP WAS UNABLE TO START DUE TO A PUMP FAILURE. THE DEFECTIVE IMPELLA DEVICE WAS REMOVED, AND A NEW IMPELLA DEVICE WAS INSERTED, WHICH PERFORMED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122969 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 PUMP 381 PUMP SET (US) 2026750826 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1