BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 23954141 · Received January 4, 2026

    Report

    Report Number
    1220648-2026-00036
    Event Type
    Death
    Date Received
    January 4, 2026
    Date of Event
    December 9, 2025
    Report Date
    January 29, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS DISCARDED BY THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PRODUCT OR DATA LOGS RETURNED. PUMP SUCTION: CLINICAL DETAILS MENTION SUCTION ALARMS OCCURRING ON (B)(6) 2025 DURING IMPELLA SUPPORT. P-LEVEL WAS REDUCED FROM P-7 TO P-6, PATIENT WAS ADMINISTERED ALBUMIN, AND P-LEVEL WAS FURTHER TURNED DOWN TO P-4 AS SUCTION WAS SEEN ON INCREASING P-LEVEL TO P-5. THE PATIENT RECEIVED ALBUMIN OVERNIGHT AS WELL FOR SUCTION. THE ROOT CAUSE OF THE SUCTION ALARMS WAS NOT DETERMINED DUE TO LACK OF CONCLUSIVE EVIDENCE FROM THE CLINICAL DETAILS AND UNRETURNED PRODUCT OR LOGS FOR ADDITIONAL EVALUATION. HYPOTENSION: CLINICAL DETAILS MENTION THAT THE PATIENT SUFFERED FROM SEIZURES WITH SUBSEQUENT VENT DESYNCHRONY AND HYPOTENSION. THE ROOT CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT: 1961529. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW PUMP #618275 PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A PATIENT WAS ON AN IMPELLA CP FOR ACUTE MYOCARDIAL INFARCTION. IT WAS REPORTED THAT DURING SUPPORT, THE PATIENT DEVELOPED HYPOTENSION AND WAS STARTED ON A VASOPRESSOR. IT WAS FURTHER REPORTED THAT THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15295 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026750790 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention| D