BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24392565 · Received February 19, 2026

    Report

    Report Number
    1220648-2026-03598
    Event Type
    Injury
    Date Received
    February 19, 2026
    Date of Event
    February 7, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE STATUS. 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

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. INVESTIGATION SUMMARY PPAE (MAJOR BLEED): THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINICAL RATIONALE UPDATED: A 61-YEAR-OLD MALE WITH AN UNDERLYING INDICATION OF CARDIOMYOPATHY UNDERWENT IMPLANTATION OF AN IMPELLA 5.5 (PUMP 2; CASE (B)(4), GU CASE (B)(4)). THE CLINICAL TEAM REPORTED THAT THE PATIENT DEVELOPED A GASTROINTESTINAL BLEED AND ISCHEMIC BOWEL. BASED ON THE INFORMATION PROVIDED, THE PATIENT EXPERIENCED SIGNIFICANT BLEEDING COMPLICATIONS, INCLUDING GI BLEED AND ISCHEMIC BOWEL, WHILE SUPPORTED WITH THE IMPELLA 5.5. A DEVICE RELATED CONTRIBUTION CANNOT BE DETERMINED AT THIS TIME; FURTHER INVESTIGATION WILL PROCEED UPON RECEIPT OF ADDITIONAL CLINICAL DETAILS AND/OR PRODUCT EVALUATION. BLEEDING WAS NOTED AND THIS IS A KNOWN RISK PER OUR IFU (INSTRUCTIONS FOR USE) BECAUSE OF OUR ANTICOAGULATION AND PURGE REQUIREMENTS. THE PATIENT SURVIVED EXPLANT AND WAS BRIDGED TO TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176282 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026795470 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Other