BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA RP FLEX

    MDR report key: 23936492 · Received December 31, 2025

    Report

    Report Number
    1220648-2025-49732
    Event Type
    Injury
    Date Received
    December 31, 2025
    Date of Event
    December 10, 2025
    Report Date
    February 25, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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

    CORRECTIONS TO THE FOLLOWING SECTIONS: D4 CATALOG NUMBER. H6 CLINICAL CODE E0303 REMOVED. H6 MED DEV PROB CODE ADDED A0709 AND REMOVED A01. H6 COMPONENT CODE UPDATED FROM G04105 TO G07003. ADDITIONAL INFORMATION: B1 PRODUCT PROBLEM SELECTED. THE INVESTIGATION FOR THE MAJOR BLEED, HEMATURIA, RENAL FAILURE HAS BEEN COMPLETED. THE CAUSE OF THE INJURIES WERE NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE INVESTIGATION FOR THE PLACEMENT SIGNAL ISSUE HAS ALSO BEEN COMPLETED. THE CAUSE OF THE PLACEMENT SIGNAL ISSUE COULD NOT BE DETERMINED AS NO PRODUCT WAS RETURNED FOR EVALUATION AND LIMITED CLINICAL DETAILS WERE PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA RP FLEX EXPERIENCED BLEEDING ISSUES PRIOR TO IMPLANTATION THAT CONTINUED DURING SUPPORT, INCLUDING HEMATURIA. THE PATIENT WAS TRANSFUSED MULTIPLE UNITS OF PACKED RED BLOOD CELLS, PLATELETS, AND FRESH FROZEN PLASMA. THE PATIENT ALSO EXPERIENCED PLACEMENT SIGNAL NOT RELIABLE ALARMS. THE ALARM WAS DISABLED. THE PATIENT WAS PUT ON CONTINUOUS RENAL REPLACEMENT THERAPY AND BURMEX GTT IN RESPONSE TO RENAL FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111485 IMPELLA RP FLEX TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. IMPELLA RP FLEX 2026671817 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention