BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA CP

    MDR report key: 24092778 · Received January 16, 2026

    Report

    Report Number
    1220648-2026-00895
    Event Type
    Malfunction
    Date Received
    January 16, 2026
    Date of Event
    January 10, 2026
    Report Date
    January 16, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS NOT BEEN RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE HAS NOT BEEN POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION NOTED THE IMPELLA DEVICE WAS RECEIVED, AND AN EVALUATION/ANALYSIS IS UNDERWAY. UPON COMPLETION OF THE EVALUATION/ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED. CORRESPONDINGLY, SECTIONS D9: DEVICE RECEIVED BY MANUFACTURER WITH RECEIPT DATE AND H6: INVESTIGATION TYPE, FINDINGS AND CONCLUSION CODES WERE UPDATED ACCORDINGLY. 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

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. UPDATED INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. PUMP STOP: THE CAUSE OF THE PUMP STOP WAS MATERIAL WEAR OF THE BALL BEARINGS DUE TO THE LARGE IMPELLOR PURGE GAP SEEN ON THE RETURNED PRODUCT. AS THIS OCCURRED ON DAY 23 OF SUPPORT THE CAUSE OF THIS BEARING WEAR IS AN END-OF-LIFE PROBLEM AS PER DESIGN TRACE MATRIX 0046-9910, THE DESIGN LIFE OF CP C9+ IS 8 DAYS.

    Additional Manufacturer Narrative · 0

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. INVESTIGATION SUMMARY: PUMP STOP: THE CAUSE OF THE PUMP STOP WAS NOT DETERMINED DUE TO NO PRODUCT RETURNED, NO DATA LOGS RECOVERED, AND INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT ON IMPELLA SUPPORT WITH A CP PUMP. THE COMPLAINANT REPORTED A PUMP STOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624868 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026732225 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1