BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24576804 · Received March 12, 2026

    Report

    Report Number
    1220648-2026-05075
    Event Type
    Injury
    Date Received
    March 12, 2026
    Date of Event
    November 19, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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

    A 57-YEAR-OLD PATIENT WAS ADMITTED THROUGH THE CLINIC WITH INCREASING EDEMA AND SHORTNESS OF BREATH. HE UNDERWENT HEART CATH AND REQUIRED INTUBATION FOR RESPIRATORY DISTRESS WHILE LAYING FLAT. HE BECAME HYPOTENSIVE AND ARRESTED. AN IMPELLA CP WAS PLACED AND FOLLOWED WITH VA ECMO. THE PATIENT WAS UPGRADED TO AN IMPELLA 5.5 ONCE HE WAS TRANSFERRED. HE WAS ANEMIC, NECESSITATING BLOOD TRANSFUSIONS. THE PATIENT WAS DECANNULATED FROM ECMO ON (B)(6) 2025 WITH REPAIR OF THE GROIN CANNULATION SITE. DUE TO ONGOING NEED FOR MECHANICAL VENTILATION, THE PATIENT WAS TRACHED. HE WAS KNOWN TO HAVE IVC CLOT. HEMATOMAS WERE NOTED AT THE LEFT GROIN AND RIGHT PECTORALIS AREA, BOTH IMPELLA IMPLANT SITES. THE IMPELLA 5.5 WAS WEANED OFF AND REMOVED ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628149 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026745070 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention