BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24205987 · Received January 28, 2026

    Report

    Report Number
    1220648-2026-01751
    Event Type
    Injury
    Date Received
    January 28, 2026
    Date of Event
    January 19, 2026
    Report Date
    March 30, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    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

    THIS REPORT IS BEING SUBMITTED TO DOCUMENT THE FINAL INVESTIGATION CONCLUSIONS AND TO CORRECT A PREVIOUSLY REPORTED H6 MEDICAL DEVICE PROBLEM CODE. THE PROBLEM CODE A141101 (DECREASE IN PRESSURE) REPORTED ON THE INITIAL MDR WAS NOT APPLICABLE TO THE EVENT AND HAS BEEN REMOVED. H6 COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS CODES HAVE BEEN UPDATED TO REFLECT INVESTIGATION CLOSURE. INVESTIGATION SUMMARY: THE CAUSE OF THE HIGH PURGE PRESSURE COULD NOT BE DETERMINED AS NO PRODUCT OR LOGS WERE RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION: D1 BRAND NAME CHANGED. D4 UDI NUMBER CORRECTED. H6 TYPE OF INVESTIGATION ADDED B18. ADDITIONAL INFORMATION WAS PROVIDED WHICH STATES THAT STATES ONCE THE DEVICE WAS EXPLANTED, THE FACILITY DISPOSED OF IT.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS NOT BEEN RECEIVED FROM THE CUSTOMER. THEREFORE, INVESTIGATION OF THE DEVICE IS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. AT THIS TIME, NO DEFINITIVE ROOT CAUSE FOR THE PURGE PRESSURE FLUCTUATIONS HAS BEEN DETERMINED. DEVICE EVALUATION IS PENDING RETURN AND ANALYSIS. ADDITIONAL INVESTIGATION WILL BE COMPLETED UPON RECEIPT OF THE DEVICE TO ASSESS FOR POTENTIAL MECHANICAL, PURGE SYSTEM, OR THROMBUS RELATED CONTRIBUTORS.

    Description of Event or Problem · 0

    A 62-YEAR-OLD FEMALE PATIENT WAS SUPPORTED WITH AN IMPELLA 5.5 DEVICE FOR THE INDICATION OF POSTCARDIOTOMY CARDIOGENIC SHOCK (PCCS). THE DEVICE (IMPELLA 5.5, SN (B)(6); PUMP 1: (B)(4); GU CASE (B)(4)) WAS SURGICALLY INSERTED VIA DIRECT AORTIC ACCESS ON THE RIGHT SIDE ON (B)(6) 2026 AT 1:45 PM. DURING INSERTION, A SUDDEN DECREASE IN PURGE FLOW WAS OBSERVED, ACCOMPANIED BY AN INCREASE IN PURGE PRESSURE. NO SYSTEM ALARMS WERE REPORTED AT THE TIME OF THE EVENT. DUE TO CONCERN REGARDING THE POTENTIAL RISK OF THROMBUS FORMATION. THE CLINICAL TEAM ELECTED TO REMOVE THE DEVICE OUT OF PRECAUTION FOR POTENTIAL THROMBUS FORMATION; HOWEVER, NO CLOT WAS OBSERVED UPON DEVICE EXPLANT. THE PATIENT REMAINED STABLE ON ECMO. AT THIS TIME, NO DEFINITIVE ROOT CAUSE FOR THE PURGE PRESSURE FLUCTUATIONS HAS BEEN DETERMINED. DEVICE EVALUATION IS PENDING RETURN AND ANALYSIS. ADDITIONAL INVESTIGATION WILL BE COMPLETED UPON RECEIPT OF THE DEVICE TO ASSESS FOR POTENTIAL MECHANICAL, PURGE SYSTEM, OR THROMBUS RELATED CONTRIBUTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267445 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 WITH SMARTASSIST S2 SET, US 2026772397 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention