BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 23262918 · Received October 9, 2025

    Report

    Report Number
    1220648-2025-47367
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    September 9, 2025
    Report Date
    February 19, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED HEMATURIA, MAJOR BLEED, AND PRODUCT SUCTION HAS BEEN COMPLETED. NO PRODUCT WAS RETURMED FOR REVIEW. THE ROOT CAUSE OF THE HEMATURIA AND MAJOR BLEED WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. PATIENT HAD SUCTION EVENTS WHICH RESOLVED OVER NIGHT REQUIRING FLUIDS AND ALBUMIN. AFTER REVIEWING LOGS, MULTIPLE SUCTION ALARMS WERE OBSERVED. NO MOTOR CURRENT SPIKE OR PLACEMENT SIGNAL TREND WAS OBSERVED. THE ROOT CAUSE OF PUMP SUCTION WAS MOST LIKELY PATIENT CONDITION RELATED SINCE THE SUCTION ALARMS RESOLVED AFTER FLUIDS WAS GIVEN TO THE PATIENT.

    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

    H6: ADDED CODE A070908. ADDITIONAL INFORMATION. THE PLACEMENT SIGNAL READING WAS INACCURATE ( 20S/-9). PATIENT WAS HEMODYNAMICALLY STABLE AND POSITION ADEQUATE UNDER ECHOCARDIOGRAM. REPORTED THAT THE DEVICE WAS EXHIBITING A ¿PLACEMENT SIGNAL NOT RELIABLE¿ ALARM.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION HAS BEEN PROVIDED IN E4. UPON REVIEW, IT WAS IDENTIFIED THAT THE INFORMATION WAS INADVERTENTLY NOT SUBMITTED IN THE INITIAL REPORT.

    Additional Manufacturer Narrative · 0

    B5 UPDATED. THE INVESTIGATION IS STILL REOPENED AND ONGOING.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT A PATIENT WAS PLACED ON IMPELLA 5.5 TO STABILIZE WHILE WORKING UP FOR VENTRICLE ASSISTED DEVICE VS TRANSPLANT. DURING SUPPORT PINK URINE WAS REPORTED. IN ADDITION TO SUCTION EVENTS REQUIRING FLUIDS AND ALBUMIN. THE PATIENT ALSO RECEIVED 1 UNIT PACKED RED BLOOD CELLS FOR BLEEDING FROM CT. THE PATIENT CONTINUES ON SUPPORT.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED ADDITIONAL INFORMATION UPON REQUEST: "THE INTERVENTION WAS THAT THEY TURNED DOWN FROM P9 TO P7, BUT AS PLASMA FREE WAS 30, THEY THOUGHT IT MAY JUST HAVE BEEN HEMATURIA FROM FOLEY CATHETER INSERTION. THE PATIENT REMAINS ON SUPPORT AT THIS TIME, BUT HAS TRANSFERRED TO (B)(6) HOSPITAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1936797 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 IMPELLA 5.5 2026704212

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention