BEUDAMED
    FDA Enforcement Class II Terminated

    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

    Recall: Z-0494-2021 · Reported December 2, 2020

    Enforcement

    Recall Number
    Z-0494-2021
    Event ID
    86666
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MEDTRONIC ATS MEDICAL, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 2, 2020
    Initiation Date
    October 12, 2020
    Classification Date
    November 25, 2020
    Termination Date
    August 16, 2024
    Address
    3800 Annapolis Ln N, N/A, Plymouth, MN, 55447-5439, United States

    Description

    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

    Reason

    There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

    Code Info

    Model Number 60SF3, GTIN 00763000114626 Serial Numbers: 17420000, 17420001, 17420002, 17420003, 17420004, 17420005, 17420006, 17420007, 17420008, 17420009, 17420010, 17420013, 17420014, 17420015, 17420016, 17420017, 17420018, 17420019, 17420020, 17420022, 17420023, 17420024, 17420025, 17420026, 17420027, 17420028, 17420029, 18420000, 18420001, 18420002, 18420003, 18420004, 18420015, 18420016, 18420021, 18420022, 18420023, 18420024, 18420025, 18420026, 18420027, 19820016, 19820017, 19820018, 19820019, 19820020, 19820021, 19820022, 19820023, 19820024, 21020005, 22320038, 22320040, 22320041, 22320042, 22320043, 22320044

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.

    Quantity

    57 units