BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24423841 · Received February 23, 2026

    Report

    Report Number
    1220648-2026-03856
    Event Type
    Injury
    Date Received
    February 23, 2026
    Date of Event
    February 13, 2026
    Report Date
    March 2, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D1: BRAND NAME UPDATED. H6: INVESTIGATION: TYPE, FINDINGS, CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE DEVICE WAS RETURNED FOR INVESTIGATION. HEMODYNAMIC INSTABILITY: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. PURGE PRESSURE HIGH: THE CAUSE OF THE HIGH PURGE PRESSURE WAS DUE TO BIOMATERIAL BUILDUP BASED ON FIELD LOG ANALYSIS TREND AND RETURNED PRODUCT WITH BIOMATERIAL IN THE PURGE GAP AND BLOOD IN PURGE LINE LIKELY CAUSED BY NO HEPARIN IN PURGE SOLUTION. PUMP STOP: THE CAUSE OF THE PUMP STOP WAS DUE TO BIOMATERIAL BUILDUP BASED ON DATA LOG ANALYSIS INDICATING GRADUAL RISE IN MOTOR CURRENT AND PUMP FLOW SATURATION AND RETURNED PRODUCT SHOWING BIOMATERIAL IN PURGE GAP AND BLOOD IN PURGE LINE LIKELY AS A RESULT OF NO HEPARIN IN PURGE SOLUTION.

    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

    UPDATED INFORMATION: D9 DEVICE RETURN DATE ADDED. G1 MFR CONTACT FAX NUMBER ADDED.

    Description of Event or Problem · 0

    CLINICAL RATIONALE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 74-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS) WITH A HISTORY OF CAD, DIABETES MELLITUS, AND RENAL INSUFFICIENCY. DURING SUPPORT, THE PUMP STOPPED, AND A PURGE BLOCKAGE WAS OBSERVED. ATTEMPTS WERE MADE TO RESTART THE DEVICE PER ABIOMED RECOMMENDATIONS; HOWEVER, THE PUMP COULD NOT BE RESTARTED. THE DEVICE WAS SUBSEQUENTLY REMOVED AND REPLACED WITH A NEW IMPELLA CP. THE REPORTED EVENTS ARE PUMP STOP, PURGE PRESSURE HIGH, DEVICE REVISION OR REPLACEMENT, AND HEMODYNAMIC INSTABILITY. THE DEVICE WILL BE CONSERVATIVELY REPORTED FOR SERIOUS INJURY DUE TO TEMPORARY HEMODYNAMIC SUPPORT INTERRUPTION DURING THE EXCHANGE; HOWEVER, THE EXCHANGE WAS PERFORMED WITH NO CONSEQUENCE TO THE PATIENT, AND SUPPORT WAS RESUMED WITHOUT ANY KNOWN ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475518 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027828012 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1