BEUDAMED
    FDA Recall Terminated

    Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. 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 MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart. Including the left side of the heart through the interatrial septum.

    Recall: Z-0132-2013 · Initiated September 24, 2012

    Recall

    Recall Number
    Z-0132-2013
    Event Number
    63316
    Firm
    Greatbatch Medical
    FEI Number
    2183787
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 24, 2012
    Posted
    October 24, 2012
    Terminated
    May 15, 2014
    Address
    2300 Berkshire Ln N, Minneapolis, MN, 55441-4575

    Description

    Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. 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 MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart. Including the left side of the heart through the interatrial septum.

    Reason

    We are notifying you of a potential interaction between therapeutic catheters and MobiCath Bi-Directional Guiding Sheaths. We became aware of these interactions while investigating recent complaints regarding catheters "self-advancing" while being used in conjunction with the MobiCath Sheaths.

    Action

    The firm, Greatbatch, Ltd., sent an "URGENT CUSTOMER NOTIFICATION Medical Device - Voluntary Field Safety Notice" dated Monday, September 24, 2012 to its customer. The letter described the product, problem and actions to be taken. The customer was instructed to read the "Description of the Problem" and "Recommendations for Clinical Use" sections carefully; complete and return the attached Field Action Acknowledgement Form via mail to: Biosense Webster, Incl, 15715 Arrow Highway, Irwindale, CA 91706; Attn: Recall Coordinator, or Fax to: (909) 839-8514; pass on this notice to anyone in your facility that needs to be informed; maintain awareness of this communication until information has been incorporated into the device labeling, and to avoid the catheter inside the MobiCath Bi-Directional Guiding Sheath from "self-advancing", physicians should reposition the catheter handle when manipulating the catheter in and out of the sheath. Greatbatch, Ltd. is updating the MobiCath Bi-Directional Guiding Sheath Instructions For Use (IFU) accordingly. Supplemental information will be provided with future shipments of these devices, until the revised IFU is available. For questions related to the issue please contact your Biosense Webster representative or call (800) 729-9010, Monday through Friday from 9:00 AM to 6:00 PM EST. For questions related to the Acknowledgment Form and its return, please contact Field Action Coordinator at (909) 839-8468.

    Distribution

    Nationwide distribution: CA only.

    Quantity

    9040