BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24349734 · Received February 16, 2026

    Report

    Report Number
    1220648-2026-03290
    Event Type
    Injury
    Date Received
    February 16, 2026
    Date of Event
    December 4, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN B5 (EVENT DESCRIPTION). 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

    D1 (BRAND NAME), D4 (CATALOG & SERIAL) HAS BEEN UPDATED. PPAE (CARDIAC TAMPONADE): THE ROOT CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    A 73-YEAR-OLD PATIENT WAS SCHEDULED FOR ELECTIVE CORONARY ARTERY BYPASS SURGERY (CABG) WITH IMPELLA 5.5 SUPPORT. HE INITIALLY HAD CARDIAC TAMPONADE REQUIRING SURGICAL TAKE-BACK FOR WASHOUT. RECEIVED BLOOD POST OPERATIVELY. SUPPORT DURING HIS ICU WAS WITHOUT INCIDENT AND HE WAS EXPLANTED ON (B)(6) 2025.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED: THE INTERVENTION WAS THE WASHOUT AND REMOVAL OF BLOOD. IT WAS SUCCESSFUL. NO. NO, PUMP WASN'T INVOLVED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532369 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US 2026765218 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1