BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24131935 · Received January 21, 2026

    Report

    Report Number
    1220648-2026-01237
    Event Type
    Injury
    Date Received
    January 21, 2026
    Date of Event
    January 12, 2026
    Report Date
    January 21, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011609
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THROMBOSIS: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE IN WRONG POSITION: THE CAUSE OF THE POSITION ISSUE WAS MOST LIKELY RELATED TO AN UNINTENTIONAL USE ISSUE, AS IT OCCURRED WHILE THE PATIENT WAS COUGHING. LOW OR BLOCKED PUMP FLOW: THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED WITHOUT THE RETURNED PRODUCT FOR INVESTIGATION AND SUFFICIENT CLINICAL DETAILS, INCLUDING DATA LOG.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS NOT BEEN RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE HAS NOT BEEN POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: ADDED CODES A150202 AND A140508 BASED ON REVIEW BY THE INVESTIGATION TEAM. OMITTED CODE A0401.

    Additional Manufacturer Narrative · 0

    D6B WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT. E4 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT ON IMPELLA SUPPORT WITH A CP PUMP. THE COMPLAINANT REPORTED THAT AN IMPELLA IN AORTA ALARM SOUNDED WHEN THE PATIENT COUGHED. THE PUMP WAS REINSERTED UNDER FLUOROSCOPY, BUT THE PUMP DID NOT RECOVER. A THROMBUS HAD FORMED. THE IMPELLA WAS SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15568 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026778580 00813502011609

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention