BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 24116458 · Received January 20, 2026

    Report

    Report Number
    1220648-2026-01138
    Event Type
    Injury
    Date Received
    January 20, 2026
    Date of Event
    December 17, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    H6 COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS CODES HAVE BEEN UPDATED TO REFLECT INVESTIGATION CLOSURE. INVESTIGATION SUMMARY: NO PRODUCT RETURN: ASAE/HEMATOMA: HEMATOMA NOTED AT INSERTION SITE. THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS USER RELATE AS ISSUE OCCURRED AFTER TRANSFER TO ICU WITH ACT VALUE 300 AND THE PATIENT KICKED LEG UP IN BED. DEVICE HISTORY LOT: DEVICE LOT: 1973974. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: THE PUMP SN (B)(6) PASSED ALL THE POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT, THERE WAS A HEMATOMA FOUND AT THE INSERTION SITE. THE PATIENT WAS GIVEN 2 UNITS OF PACKED RED BLOOD CELL (PRBC) AND PRESSOR SUPPORT WAS INCREASED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180692 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 IMPELLA CP 2026754466 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Other