BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 25031413 · Received April 29, 2026

    Report

    Report Number
    1220648-2026-07225
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    March 16, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. RELATED MEDICAL DEVICE REPORTS: THIS IMPELLA 5.5 DEVICE REPORT IS ONE OF FOUR DEVICES ASSOCIATED WITH THE EVENT.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT ON (B)(6) 2026, DURING INCOMING INSPECTION AT A DISTRIBUTOR WAREHOUSE, TWO IMPELLA 5.5 S2 PUMP SETS (SERIAL NUMBERS (B)(6)) WERE IDENTIFIED AS BEING INCORRECTLY PACKAGED IN IMPELLA CPSA BOXES. FOLLOWING THIS FINDING, THE DISTRIBUTOR REVIEWED THE REMAINING INVENTORY FROM THE SAME SHIPMENT RECEIVED IN OCTOBER 2025 AND IDENTIFIED AN ADDITIONAL TWO IMPELLA 5.5 S2 PUMP SETS (SERIAL NUMBERS (B)(6)) THAT WERE ALSO INCORRECTLY PACKAGED IN IMPELLA CPSA BOXES. THE FOUR AFFECTED UNITS WERE QUARANTINED AT THE WAREHOUSE. THE PRODUCTS HAD NOT BEEN DISTRIBUTED TO HOSPITALS OR USED IN PATIENT CARE AT THE TIME THE ISSUE WAS IDENTIFIED. NO PATIENT INVOLVEMENT OR PATIENT IMPACT WAS REPORTED IN ASSOCIATION WITH THIS EVENT. THIS COMPLAINT INVOLVES FOUR IMPELLA DEVICES: IMPELLA 5.5, WITH SERIAL NUMBER (B)(6). IMPELLA 5.5, WITH SERIAL NUMBER (B)(6). IMPELLA 5.5, WITH SERIAL NUMBER (B)(6). IMPELLA 5.5, WITH SERIAL NUMBER (B)(6). THIS MDR SPECIFICALLY ADDRESSES IMPELLA 5.5, WITH SERIAL NUMBER (B)(6), WHICH IS THE SUBJECT OF THIS REPORT. SEPARATE MDRS WILL BE SUBMITTED FOR OTHER DEVICES ASSOCIATED WITH THIS COMPLAINT, AS APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16302 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026764547

    Patients

    Seq Age Sex Outcome Treatment
    1