BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP 371 14F LT CMR SET

    MDR report key: 24298525 · Received February 9, 2026

    Report

    Report Number
    1220648-2026-02655
    Event Type
    Injury
    Date Received
    February 9, 2026
    Date of Event
    November 27, 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
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN D9. THIS REPORT IS SUBMITTED AS A FOLLOW UP TO PROVIDE ADDITIONAL INFORMATION OBTAINED AFTER THE INITIAL MDR SUBMISSION 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

    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.

    Description of Event or Problem · 0

    AN 85-YEAR-OLD MALE PATIENT WITH CARDIOGENIC SHOCK WAS INSERTED WITH AN IMPELLA CP DEVICE VIA THE LEFT FEMORAL ARTERY. DEVICE WAS DELIVERING LOWER THAN EXPECTED FLOWS, WITH ERRATIC WAVE FORM MORPHOLOGY. ATTEMPTED TO REPOSITION THE DEVICE HOWEVER FLOWS DID NOT IMPROVE. PHYSICIAN MADE DECISION TO REMOVE THE DEVICE AND PLACE A NEW IMPELLA CP. NEW IMPELLA CP PERFORMED NORMALLY AND WAS UTILIZED FOR THE DURATION OF THE CASE, AND THE PATIENT WAS SUCCESSFULLY WEANED AND EXPLANTED. IMPELLA TO BE CODED TO DEVICE REPOSITIONING AND DEVICE REVISION OR REPLACEMENT. DURING IMPELLA CP SUPPORT, LOWER THAN EXPECTED FLOWS WERE NOTED ALONG WITH POSITIONING ALARMS. FLOW DID NOT DID NOT RESOLVE AFTER STANDARD REPOSITIONING, AND THE DECISION WAS MADE TO REPLACE THE CP. NO FURTHER INFORMATION WAS PROVIDED ON PATIENT STATUS, AND NO ADDITIONAL FAILURE MODES WERE REPORTED FOR THE FIRST CP; THE SECOND CP WAS INSERTED AND USED FOR THE DURATION OF THE CASE WITHOUT ISSUES. THERE WAS NO CONSEQUENCE TO THE PATIENT AS A RESULT OF THE PUMP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352701 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 2026755436 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Required Intervention