BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24414063 · Received February 23, 2026

    Report

    Report Number
    1220648-2026-03775
    Event Type
    Injury
    Date Received
    February 23, 2026
    Date of Event
    February 13, 2026
    Report Date
    March 24, 2026
    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
    WA, 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.

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION: D1 BRAND NAME UPDATED. D4 CATALOG NUMBER UPDATED. H6 CLINICAL CODE CHANGED FROM E1302 TO E0303. H6 MED DEV PROB CODE CHANGED FROM A24 TO A01.

    Additional Manufacturer Narrative · 0

    B1 ( IS PRODUCT PROBLEM) HAS BEEN TICKED TO CAPTURE THE MALFUNCTION CODE. D3 (MANUFACTURER FAX) HAS BEEN ADDED. HEMOLYSIS/MECHANICAL INTERACTION WITH BLOOD: THE CAUSE OF HEMOLYSIS/MECHANICAL INTERACTION WITH BLOOD WAS UNABLE TO BE DETERMINED AS LIMITED CLINICAL DETAILS WERE PROVIDED AND NO PRODUCT WAS RETURNED FOR REVIEW.

    Description of Event or Problem · 0

    AN IMPELLA CP DEVICE WAS INSERTED INTO THE LEFT FEMORAL ARTERY IN A 65-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD), PRESENTING IN AN OUT-OF-HOSPITAL CARDIAC ARREST REQUIRING CARDIOPULMONARY RESUSCITATION (CPR), IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), AND IN SCAI STAGE E SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THE URINE TURNED PINK FROM YELLOW. THE SYSTEMIC VASCULAR RESISTANCE (SVR) WAS NOTED TO BE HIGH (OVER 1,600). THE SAME DAY, THE IMPELLA CP WAS REMOVED, WITH AN ESCALATION OF THERAPY TO AN IMPELLA 5.5. THE IMPELLA FUNCTIONED AT P-9 AT 3.6L/MIN WITHOUT ISSUES. THE POST-PROCEDURE OUTCOME IS SURVIVED AT EXPLANT. POOR POSITIONING OF THE IMPELLA CAN CAUSE HEMOLYSIS. HEMOLYSIS IS LISTED AS A POTENTIAL ADVERSE EVENT, AND CONSISTENT WITH KNOWN DEVICE-RELATED AND PATIENT-RELATED FACTORS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158585 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026810323 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1