BEUDAMED
    FDA Recall Terminated

    Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The kit includes a flexible catheter dilator to facilitate bi-directional guiding sheath passage.

    Recall: Z-2782-2017 · Initiated February 15, 2017

    Recall

    Recall Number
    Z-2782-2017
    Event Number
    76514
    Firm
    Greatbatch Medical
    FEI Number
    2183787
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 15, 2017
    Terminated
    May 9, 2019
    Address
    2300 Berkshire Ln N, Plymouth, MN, 55441-4575

    Description

    Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The kit includes a flexible catheter dilator to facilitate bi-directional guiding sheath passage.

    Reason

    One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed.

    Action

    Consignee was sent a Greatbatch "Urgent Medical Device Recall" letter dated February 15, 2017 via UPS and email . The letter was addressed to Biosense Webster, Inc. The letter described the product involved in the recall, Reason for Recall, Risk to Health,& Instructions to Biosense Webster. Advised consignee to quarantine and return the devices, complete and return the field Recall Response Form to Stericycle, and to communicate the recall to their customers and end users. For questions contact your local Greatbatch Medical representative, Monday through Friday via telephone at 1-763-951-8184 from 8:00 AM (CST) to 5:00 PM (CST), or e-mail us at [email protected]

    Distribution

    CA

    Quantity

    11,360