BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP 371 14F LT CMR SET

    MDR report key: 24377143 · Received February 18, 2026

    Report

    Report Number
    1220648-2026-03421
    Event Type
    Injury
    Date Received
    February 18, 2026
    Date of Event
    October 14, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 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

    B1: ADDED PRODUCT PROBLEM, THIS WAS OMITTED IN THE INITIAL REPORT IN ERROR. ADDITIONAL INFORMATION: THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE PUMP WAS EXPLANTED AND A SECOND PUMP INSERTED. THE SECOND PUMP PERFORMED APPROPRIATELY. THE FIRST PUMP WHICH DID NOT PERFORM APPROPRIATELY WAS RETURNED WITH AN RA KIT.

    Description of Event or Problem · 0

    AN 80-YEAR-OLD WOMAN WITH A HISTORY OF NON¿ST-ELEVATION MYOCARDIAL INFARCTION AND HYPERTENSION PRESENTED WITH NONSPECIFIC GASTROINTESTINAL SYMPTOMS. LABORATORY EVALUATION SHOWED A MILD ELEVATION IN CARDIAC TROPONIN, AND THE PATIENT UNDERWENT A DIAGNOSTIC CARDIAC CATHETERIZATION, WHICH REVEALED A COMPLEX LESION OF THE LEFT MAIN CORONARY ARTERY. THE PATIENT RETURNED TO THE CARDIAC CATHETERIZATION LABORATORY THE FOLLOWING DAY FOR A HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION SUPPORTED BY AN IMPELLA CP DEVICE. THE IMPELLA DEVICE WAS SUCCESSFULLY IMPLANTED. UPON INITIATION OF IMPELLA SUPPORT, THE MOTOR CURRENT WAVEFORM WAS FLAT, THE LEFT VENTRICULAR PRESSURE WAVEFORM DID NOT APPEAR, AND DEVICE FLOW WAS LOW. PROPER POSITIONING OF THE DEVICE WAS CONFIRMED. THE CLINICAL DECISION WAS MADE TO EXCHANGE THE PUMP FOR A NEW ONE TO SAFELY COMPLETE THE PROCEDURE. THE IMPELLA DEVICE WAS EXPLANTED ACCORDING TO BEST-PRACTICE TECHNIQUE, AND A NEW IMPELLA CP DEVICE WAS SUCCESSFULLY IMPLANTED. THE SECOND DEVICE FUNCTIONED APPROPRIATELY, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440278 PUMP 371 14F LT CMR SET TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 PUMP 371 14F LT CMR SET 2026681801 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention