BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 25045169 · Received April 30, 2026

    Report

    Report Number
    1220648-2026-07276
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Date of Event
    April 9, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION WAS PROVIDED IN D3 (MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN PROVIDED IN H3, H6, AND H11. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE CAUSE OF THE PLACEMENT SIGNAL ISSUE IS DUE TO A MATERIAL CRACK OF THE OPTICAL SENSOR FACE LIKELY DUE TO A FAILURE OF THE SENSOR INTERACTING WITH SHOCKWAVE.

    Additional Manufacturer Narrative · 0

    D4. SERIAL CORRECTED.

    Additional Manufacturer Narrative · 0

    D4 CATALOG WAS REVISED. PRIMARY UDI NUMBER WAS REVISED. D9 DEVICE WAS RECEIVED AND DATE RETURNED WAS ADDED. H6 TYPE OF INVESTIGATION WAS REVISED DUE TO THE DEVICE BEING RETURNED. H11 ADDITIONAL MANUFACTURER NARRATIVE WAS REVISED DUE TO THE DEVICE BEING RETURNED. THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    A4 IS UNKNOWN. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA 5.5 EXPERIENCED LOSS OF THE OPTICAL SENSOR. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334588 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027846581 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1