BEUDAMED
    FDA Recall Open, Classified

    Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 device per carton, 1 carton per box.

    Recall: Z-1131-2022 · Initiated April 20, 2022

    Recall

    Recall Number
    Z-1131-2022
    Event Number
    90089
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    OCL
    Status
    Open, Classified
    Root Cause
    Labeling design
    Initiated
    April 20, 2022
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 device per carton, 1 carton per box.

    Reason

    Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.

    Action

    A recall notification was sent to consignees on 04/20/2022 via the United Parcel Service. The letter instructs the consignees to review the updated guidance on device usage contained in the letter, share the notice to those that need to be aware, and complete the enclosed Customer Confirmation Form and email to [email protected].

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of CA, ND, MA, ID, WI, KS, UT, MN, NY, NJ, GA, MO and the countries of Australia, Belgium, China, Czech Republic, France, Germany, Greece, Israel, Italy, Kazakhstan, Latvia, Netherlands, Poland, Russian Federation, Singapore, Switzerland.

    Quantity

    1236 units