BEUDAMED
    FDA Recall Terminated

    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 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-0496-2021 · Initiated October 12, 2020

    Recall

    Recall Number
    Z-0496-2021
    Event Number
    86666
    Firm
    MEDTRONIC ATS MEDICAL, INC.
    FEI Number
    3008592544
    Product Code
    OCL
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 12, 2020
    Terminated
    August 16, 2024
    Address
    3800 Annapolis Ln N, Plymouth, MN, 55447-5439

    Description

    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 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

    Action

    In the United States (US), beginning 29-Oct-2020, a written Medical Device Correction letter will be mailed via UPS 2-day delivery to consignees who have received affected product according to Medtronic records. Consignees will be asked to complete and return a confirmation certificate, confirming they have received the notification. The letter requests the following actions: - Identify and quarantine all unused CryoFlex Surgical Ablation devices as listed in the table below. - Return all unused affected product in your inventory to Medtronic. Contact Medtronic Customer Service at 1-800-854-3570 to initiate a product return. Your local Medtronic Representative can assist you in the return of this product. - < Please complete the enclosed Customer Confirmation Form and email to [email protected]. > - Please forward this notice to all those who need to be aware within your organization.

    Distribution

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

    Quantity

    3 units