BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24568347 · Received March 11, 2026

    Report

    Report Number
    1220648-2026-05018
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    November 12, 2025
    Report Date
    March 29, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5 UPDATED. THE INVESTIGATION IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION WAS PROVIDED IN B5 AND D4 (SERIAL). H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE ROOT CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    D4, UDI, HAS BEEN CORRECTED. THE CAUSE OF THE HEMATOMA WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE PUMP PASSED ALL POST STERILE INSPECTION CHECKS.

    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

    ADDITIONAL INFORMATION HAS BEEN PROVIDED UPON REQUEST: "PRESSURE WAS HELD UNTIL BLEEDING RESOLVED. THERE IS NO PUMP FOR RETURN."

    Description of Event or Problem · 0

    UPDATED CLINICAL NARRATIVE: A 60 YEAR OLD MALE WAS ADMITTED FOR ANTERIOR MYOCARDIAL INFARCTION. AN IMPELLA CP WAS PLACED VIA THE RIGHT FEMORAL ARTERY AND A PERCUTANEOUS CORONARY INTERVENTION PERFORMED. FOLLOWING PLACEMENT, A SMALL HEMATOMA AT THE ACCESS SITE WAS NOTED THAT DID NOT ELICIT A THERAPEUTIC INTERVENTION. THE FIELD REPRESENTATIVE RESPONDED THAT PRESSURE WAS HELD UNTIL BLEEDING RESOLVED. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND THE IMPELLA CP COULD BE SUCCESSFULLY WEANED AND REMOVED AFTER 2 DAYS OF SUPPORT.

    Description of Event or Problem · 0

    A 60-YEAR-OLD MALE WAS ADMITTED FOR ANTERIOR MYOCARDIAL INFARCTION. AN IMPELLA CP WAS PLACED VIA THE RIGHT FEMORAL ARTERY AND A PERCUTANEOUS CORONARY INTERVENTION PERFORMED. FOLLOWING PLACEMENT, A SMALL HEMATOMA AT THE ACCESS SITE WAS NOTED THAT DID NOT ELICIT A THERAPEUTIC INTERVENTION. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND THE IMPELLA CP COULD BE SUCCESSFULLY WEANED AND REMOVED AFTER 2 DAYS OF SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456983 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026674006 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1