BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24601476 · Received March 14, 2026

    Report

    Report Number
    1220648-2026-05276
    Event Type
    Injury
    Date Received
    March 14, 2026
    Date of Event
    December 13, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HEMOLYSIS/MECHANICAL INTERACTION WITH BLOOD: NO LOGS WERE RETURNED. THE CAUSE OF THE HEMOLYSIS WAS MOST LIKELY USE RELATED TO IMPROPER POSITIONING PER CLINICAL DETAILS THAT REPOSITIONING THE PUMP RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    D1 BRAND NAME WAS REVISED. D4 SERIAL AND PRIMARY UDI NUMBER WERE REVISED.

    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.

    Description of Event or Problem · 0

    A 35-YEAR-OLD MALE WITH CARDIOMYOPATHY AND A PRE SUPPORT CLINICAL STATE CONSISTENT WITH SCAI SHOCK STAGE E UNDERWENT PLACEMENT OF TWO IMPELLA CP PUMPS FOR HEMODYNAMIC SUPPORT. PUMP 1 (S/N: (B)(6); (B)(4) WAS IMPLANTED ON (B)(6) 2025 AT 09:00 AND EXPLANTED THE SAME DAY AT 12:30 DUE TO FAILURE TO ADVANCE. PUMP 2 (S/N: (B)(6); (B)(4); GU CASE (B)(4) WAS IMPLANTED ON (B)(6) 2025 AT 12:30. DURING SUPPORT WITH PUMP 2, THE PATIENT EXPERIENCED POSSIBLE POSITION RELATED HEMOLYSIS AFTER AN INITIALLY UNEVENTFUL 24 HOURS. THERE WERE NO INDICATIONS THAT THE PUMP HAD SHIFTED; HOWEVER, REPOSITIONING OF THE DEVICE WAS PERFORMED, AFTER WHICH THE HEMOLYSIS RESOLVED. BASED ON AVAILABLE INFORMATION, THE PATIENT EXPERIENCED HEMOLYSIS THAT WAS LIKELY ASSOCIATED WITH PUMP POSITIONING, AND THE ISSUE RESOLVED FOLLOWING DEVICE REPOSITIONING. THE DEVICE PERFORMED AS EXPECTED AFTER ADJUSTMENT, AND THE PATIENT ULTIMATELY STABILIZED AND WAS SUCCESSFULLY WEANED FROM SUPPORT. NO ADDITIONAL ADVERSE PATIENT OUTCOMES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92549 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026732038 813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1