BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24565363 · Received March 10, 2026

    Report

    Report Number
    1220648-2026-04949
    Event Type
    Injury
    Date Received
    March 10, 2026
    Date of Event
    February 28, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    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.

    Additional Manufacturer Narrative · 0

    B5 CLINICAL NARRATIVE UPDATED. THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. D9 UPDATED.

    Additional Manufacturer Narrative · 0

    A CORRECTION HAS BEEN MADE FOR THE DATE DEVICE RETURNED TO MANUFACTURER

    Additional Manufacturer Narrative · 0

    THE CAUSE OF THE CONTROLLER ERROR ALARM WAS A COMMUNICATION ANOMALY BETWEEN THE OPTICAL PRESSURE MEASURING UNIT AND THE MAIN COMPUTER. ADDITIONAL INFORMATION HAS BEEN PROVIDED IN H6 (COMPONENT CODE, INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, AND INVESTIGATION CONCLUSIONS).

    Additional Manufacturer Narrative · 0

    A MEDSUN MANDATORY AND VOLUNTARY REPORT FORM 3500A WAS RECEIVED, AND ADDITIONAL INFORMATION FROM THE REPORT INDICATED THAT THE ¿CONTROLLER FAILURE. REPLACE CONTROLLER¿ MESSAGE OCCURRED BUT EVENTUALLY CLEARED. SECTION E4 (REPORTER ALSO SENT REPORT TO THE FDA) WAS UPDATED TO CONFIRM RECEIPT OF THE MEDSUN REPORT. CORRECTION: E1 INITIAL REPORTER'S TITLE AND OCCUPATION WERE UPDATED, AND D1 BRAND NAME WAS CORRECTED ACCORDINGLY.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THE CONTROLLER STOPPED WORKING AND A CONTROLLER FAILURE (RED ALARM) OCCURRED. THE CONTROLLER WAS EXCHANGED FOR ANOTHER CONTROLLER, WHICH IS FUNCTIONING PROPERLY.

    Description of Event or Problem · 0

    CLINICAL RATIONALE: AN IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 57-YEAR-OLD MALE PATIENT WITH CARDIOMYOPATHY, PRESENTING IN SCAI STAGE D SHOCK. DURING SUPPORT, THE CLINICAL TEAM DOCUMENTED A CONTROLLER FAILURE INVOLVING THE AIC CHARACTERIZED BY A RED ALARM AND CESSATION OF CONTROLLER FUNCTION. NO PATIENT COMPROMISE WAS REPORTED. THE RN SWAPPED THE NON FUNCTIONAL CONTROLLER FOR ANOTHER AIC, AFTER WHICH SUPPORT CONTINUED NORMALLY. THERE WERE NO ALLEGATIONS OF DEVICE MALFUNCTION IMPACTING HEMODYNAMICS, AND THE PUMP ITSELF REMAINED IN PLACE. NO DATA DOWNLOAD WAS REQUIRED, NO REPLACEMENT WAS REQUESTED, AND NO CONTRIBUTING FACTORS WERE IDENTIFIED. PRODUCT RETURN REMAINS GFE PENDING. BASED ON THE AVAILABLE INFORMATION, THE EVENT REPRESENTS AN AIC CLINICAL USE ISSUE, SPECIFICALLY A CONTROLLER FAILURE RESOLVED THROUGH ROUTINE CONSOLE EXCHANGE, WITH NO EVIDENCE OF IMPELLA PUMP MALFUNCTION AND NO PATIENT HARM. THE DEVICE CONTINUED FUNCTIONING APPROPRIATELY ONCE CONNECTED TO THE REPLACEMENT CONTROLLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615757 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 1431282

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention