BEUDAMED
    FDA Enforcement Class II Ongoing

    EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01

    Recall: Z-2320-2026 · Reported June 17, 2026

    Enforcement

    Recall Number
    Z-2320-2026
    Event ID
    98797
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    BERLIN HEART GMBH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2026
    Initiation Date
    April 24, 2026
    Classification Date
    June 5, 2026
    Address
    Wiesenweg 10, N/A, Berlin, N/A, N/A, Germany

    Description

    EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01

    Reason

    Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.

    Code Info

    REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254

    Distribution

    US Nationwide distribution in the states of MA, SC.

    Quantity

    3