BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24466436 · Received February 27, 2026

    Report

    Report Number
    1220648-2026-04180
    Event Type
    Death
    Date Received
    February 27, 2026
    Date of Event
    November 1, 2025
    Report Date
    April 27, 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
    IN, 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. CORRECTED INFORMATION WAS PROVIDED IN D4. UPON REVIEW, THE PRIMARY UDI NUMBER HAS BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    A12 REMOVED FROM H6. A1414 ADDED TO H6. CORRECTED DATA, D1 UPDATED/CORRECTED. THE INVESTIGATION IS STILL ONGOING.

    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

    CORRECTED: D4 (SERIAL & CATALOG). CARDIAC ARREST: THE CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. PRIMING PROBLEM: NO LOGS WERE RETURNED. THE CAUSE OF THE PRIMING PROBLEM CANNOT BE DETERMINED SINCE NO PRODUCT OR DATA LOGS WERE RETURNED AND INSUFFICIENT CLINICAL DETAILS WERE PROVIDED.

    Description of Event or Problem · 0

    A SEVENTY-ONE-YEAR-OLD MAN PRESENTED TO THE HOSPITAL WITH CHEST PAIN AND SHORTNESS OF BREATH. HE WAS TAKEN TO THE CARDIAC CATHETERIZATION LAB (CCL) FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) AND WHILE VASCULAR ACCESS WAS BEING OBTAINED, HE DETERIORATED. DECISION TAKEN TO INSERT IMPELLA CP PRIOR TO PCI. PUMP IMPLANTED BUT PURGE NOT CONNECTED. ABIOMED STAFF IN ROUTE TO HOSPITAL CALLED FOR ADVICE AND RECOMMENDED CHANGE PUMP OUT DUE TO RISK TO MOTOR UNIT. PUMP REMOVED BUT PATIENT DEVELOPED CARDIAC ARREST AND WAS TREATED WITH SUCCESSFUL RETURN OF SPONTANEOUS CIRCULATION (ROSC). AS NEW IMPELLA CP WAS BEING PRIMED PATIENT DEVELOPED CARDIAC ARREST AGAIN AND A DECISION WAS REACHED TO WITHDRAW TREATMENT. PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384934 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2025574711 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1