BEUDAMED
    FDA Recall Open, Classified

    Cardioblate CryoFlex Surgical Ablation Console

    Recall: Z-0273-2022 · Initiated September 27, 2021

    Recall

    Recall Number
    Z-0273-2022
    Event Number
    88845
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    OCL
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    September 27, 2021
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    Cardioblate CryoFlex Surgical Ablation Console

    Reason

    There is potential for intermittent electrical connectivity between the console and probe.

    Action

    In the United States (US), beginning 27-SEP-2021 Medtronic initiated communications of an Urgent Medical Device Correction letter via 2-day UPS delivery to consignees who have received affected product according to Medtronic records. Outside of the United States (OUS), beginning 27-SEP-2021, a written Urgent Medical Device Correction letter is being delivered via regionally approved methods to consignees who have received affected product according to Medtronic records. Consignees are asked to review the Medtronic Urgent Medical Device Correction notification and follow the Recommended Actions, including quarantining affected Cardioblate CryoFlex Surgical Ablation Consoles in their inventory for servicing.

    Distribution

    Distribution in US - IL, KS, and UT Distribution outside of US to Australia and South Korea

    Quantity

    7 devices