BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24081063 · Received January 15, 2026

    Report

    Report Number
    1220648-2026-00851
    Event Type
    Injury
    Date Received
    January 15, 2026
    Date of Event
    December 18, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A6 IS UNKNOWN. INVESTIGATION SUMMARY: PPAE: (ISCHEMIA): THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT: 1990722. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: THIS PUMP SN (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA CP EXPERIENCED LEG ISCHEMIA THAT REQUIRED REMOVAL OF THE DEVICE. IT WAS REPORTED ON THE FIRST DAY OF SUPPORT, THE IMPELLA CP REPOSITIONING SHEATH CAUSED LEG ISCHEMIA. THE PATIENT WAS EMERGENTLY TAKEN TO THE OPERATING ROOM TO UNDERGO IMPELLA CP REMOVAL AND REPAIR TO THE RIGHT FEMORAL ARTERY WITH PROPHYLACTIC FASCIOTOMIES OF THE RIGHT LOWER LEG. A THROMBECTOMY WAS ATTEMPTED, BUT NO THROMBUS WAS FOUND. MULTIPHASIC FLOW IN THE DORSALIS PEDIS AND POSTERIOR TIBIAL ARTERIES WERE REPORTED POST-OPERATIVELY. AFTER THE IMPELLA CP WAS EXPLANTED, THE PATIENT WAS IMPLANTED WITH AN IMPELLA 5.5 VIA THE AXILLARY ARTERY. AT THE TIME OF WRITING THIS REPORT, THE PATIENT REMAINS ON IMPELLA 5.5 SUPPORT. IT WAS NOTED THAT THE PATIENT EXPERIENCED BLEEDING DURING IMPELLA 5.5 SUPPORT. THIS COMPLAINT INVOLVES TWO IMPELLA DEVICES: PUMP 1: IMPELLA CP, WITH SERIAL NUMBER (B)(6). PUMP 2: IMPELLA 5.5, WITH SERIAL NUMBER (B)(6). THIS MDR SPECIFICALLY ADDRESSES IMPELLA CP, WITH SERIAL NUMBER (B)(6), WHICH IS THE SUBJECT OF THIS REPORT. SEPARATE MDRS WILL BE SUBMITTED FOR THE OTHER DEVICES ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142703 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026786817 813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention