BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAP FEMORAL VENOUS CANNULA

    MDR report key: 24991489 · Received April 25, 2026

    Report

    Report Number
    1718850-2026-90004
    Event Type
    Malfunction
    Date Received
    April 25, 2026
    Date of Event
    December 1, 2025
    Report Date
    April 30, 2026
    Manufacturer
    LIVANOVA USA INC.
    Product Code
    DWF
    UDI-DI
    00803622125805
    PMA / PMN Number
    K052081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11 CORRECTED SECTION G6 TYPE OF REPORT FROM 5 DAY MDR TO 30 DAY MDR.

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. H11: THIS REPORT IS LINKED TO MW 9680841-2026-900015. UPDATED D3 MANUFACTURER NAME, CITY AND STATE TO LIVANOVA USA INC [(B)(6)] AND G1 CONTACT OFFICE - MANUFACTURING SITE TO LIVANOVA USA INC [(B)(6)]. THROUGH FOLLOW-UP COMMUNICATIONS, LIVANOVA LEARNED ABOUT A SIMILAR EVENT INVOLVING SAME CANNULA BATCH LOT. REPORTEDLY, THE EVENT OCCURRED SHORTLY AFTER CANNULA INSERTION, AND IT WAS SOLVED BY REPLACING THE CANNULA CONNECTOR WITH A 3/8" 3/8" STRAIGHT CONNECTOR. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    LIVANOVA USA RECEIVED A REPORT OF AIR INTAKE IN THE VENOUS LINE DURING READJUSTMENT OF A RAP FEMORAL VENOUS CANNULA. CANNULA WAS CLAMPED TO AVOID FURTHER AIR INGRESS, RESULTING IN LINE DAMAGE. THE EVENT OCCURRED DURING AN ECMO PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY. REPORTEDLY, IT IS UNDETERMINED IF THIS IS AN ACTUAL PRODUCT PROBLEM OR USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052181 RAP FEMORAL VENOUS CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF LIVANOVA USA INC. 23/25 2510400157 00803622125805

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown