BEUDAMED
    FDA Enforcement Class II Ongoing

    Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    Recall: Z-2199-2026 · Reported May 20, 2026

    Enforcement

    Recall Number
    Z-2199-2026
    Event ID
    98708
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Sustainability Solutions
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    May 20, 2026
    Initiation Date
    April 10, 2026
    Classification Date
    May 13, 2026
    Address
    1810 W Drake Dr, Tempe, AZ, 85283-4327, United States

    Description

    Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    Reason

    Incomplete seals on sterile product

    Code Info

    UDI00885825011260, Lot Numbers: 4147881, 4760091, 4848398, 4966192, 4995002, 5022496, 5053580, 4470118, 4778468, 4848976, 4966193, 4999115, 5029362, 5063586, 4490754, 4796800, 4855294, 4966194, 5002565, 5029363, 5068369, 4509009, 4815121, 4866012, 4966195, 5002566, 5029364, 5076464, 4527883, 4815122, 4874149, 4969132, 5002873, 5029535, 5085337, 4655115, 4820151, 4883354, 4973129, 5009392, 5029698, 5085818, 4720484, 4826777, 4890964, 4981099, 5014818, 5032181, 4730762, 4845060, 4940777, 4982418, 5017600, 5032182, 4754876, 4846853, 4941142, 4987516, 5018180, 5039989, 4758759, 4847494, 4948941, 4989050, 5018181, 5044865.

    Distribution

    US Nationwide and the countries of Israel and Canada.

    Quantity

    87 units