BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 23758176 · Received December 9, 2025

    Report

    Report Number
    1220648-2025-48842
    Event Type
    Injury
    Date Received
    December 9, 2025
    Date of Event
    November 9, 2025
    Report Date
    December 2, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502013344
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: OMITTED CODE A040101 AND ADDED CODE A0401 PER A REVIEW OF THE COMPLAINT FILE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED AND PROVIDED THE FOLLOWING EVENT DETAILS: THE EXPLANT TOOK PLACE IN THE INTENSIVE CARE UNIT. THERE WAS NO RESISTANCE NOTED ON IMPLANT OR EXPLANT OF THE DEVICE. THERE WAS NO INDICATION THAT THE PUMP WAS CAUGHT IN ANY ANATOMICAL STRUCTURES, AND ACCORDING TO THE INTENSIVE CARE UNIT, IT WAS A ROUTINE REMOVAL OF THE IMPELLA. A COMPLEX REMOVAL WAS NOT EXPECTED. THE INVESTIGATION IS IN PROGRESS. 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 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED AND NOTED INFECTION LIKELY NOT RELATED TO THE IMPELLA DEVICE USED. THE INFORMATION WAS REVIEWED BY CLINICAL. IT WAS DETERMINED THAT THE INFECTION WAS A PRE-EXISTING CONDITION AND IS UNRELATED TO THE DEVICE. REFER TO B5 (EVENT DESCRIPTION) FOR THE CLINICAL ASSESSMENT. FOLLOWING CLINICAL'S REVIEW OF THE EVENT, H1 TYPE OF REPORTABLE EVENT WAS UPDATED, REQUIRING CORRECTION TO SERIOUS INJURY FROM MALFUNCTION. B1 ADVERSE EVENT/PRODUCT PROBLEM AND B2 TYPE OF REPORTABLE EVENT WERE UPDATED ACCORDINGLY. ADDITIONALLY, CODING (H6 HEALTH EFFECT - CLINICAL/IMPACT AND MEDICAL DEVICE PROBLEM) WAS UPDATED AND HAS BEEN REPOPULATED TO ENSURE ALIGNMENT BETWEEN THE RECORD AND REPORTING. CORRECTION. B3 DATE OF EVENT WAS INADVERTENTLY REPORTED AS OCCURRING AFTER THE AWARENESS DATE IN THE INITIAL SUBMISSION. THE EVENT DATE HAS BEEN CORRECTED ACCORDINGLY. CORRECTION. D4 CATALOG NUMBER AND D4 SERIAL NUMBER WERE UPDATED, CORRECTED ACCORDINGLY.

    Description of Event or Problem · 0

    THE USER FACLITY REPORTED AN IMPELLA CP IN A 40 YEAR OLD MALE FOR HEART FAILURE SUPPORT. THE PUMP APPEARS TO BE BROKEN OFF AT TRANSITION FROM CANNULA TO THE OUTLET. IT ALSO TORN IN THE MIDDLE. ACCORDING TO THE INTENSIVE CARE PHYSICIAN, NO FORCE WAS REQUIRED TO REMOVE THE IMPELLA. THE OTHER HALF OF THE PUMP WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330100 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026757316 00813502013344

    Patients

    Seq Age Sex Outcome Treatment
    1