BEUDAMED
    FDA Recall Terminated

    Enpath Steerable Sheath, model 10775-003, Sterile EO. Single Use Only. Enpath Medical, Inc., 15301 Highway 55 West, Minneapolis, MN 55447, USA. The Enpath Deflectable Catheter is a felexible tipped percutaneous catheter designed for gaining access to the peripheral and coronary systems. The device features adjustable tip geometry through use of a sliding mechanism with locking feature to deflect the catheter. There are two versions of the tool: one with a luer fitting for Tuohy-Borst valve connection, the other with a hemostasis valve and a sideport infusion line. The kit includes a flexible catheter dilator to facilitate deflectable catheter passage.

    Recall: Z-1573-05 · Initiated August 31, 2005

    Recall

    Recall Number
    Z-1573-05
    Event Number
    33338
    Firm
    Enpath Medical, Inc.
    FEI Number
    2183787
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 31, 2005
    Posted
    September 21, 2005
    Terminated
    July 22, 2006
    Address
    15301 Highway 55, Plymouth, MN, 55447-1418

    Description

    Enpath Steerable Sheath, model 10775-003, Sterile EO. Single Use Only. Enpath Medical, Inc., 15301 Highway 55 West, Minneapolis, MN 55447, USA. The Enpath Deflectable Catheter is a felexible tipped percutaneous catheter designed for gaining access to the peripheral and coronary systems. The device features adjustable tip geometry through use of a sliding mechanism with locking feature to deflect the catheter. There are two versions of the tool: one with a luer fitting for Tuohy-Borst valve connection, the other with a hemostasis valve and a sideport infusion line. The kit includes a flexible catheter dilator to facilitate deflectable catheter passage.

    Reason

    Enpath has become aware that some of the Enpath Medical 8 Fr Steerable sheath devices may have non-conforming hemostasis valves in that the valve can leak or the valve was observed to have a small hole.

    Action

    Clinical locations were sent an Urgent Medical Device Recall letter dated 09/02/05 from Enpath Medical, Inc. The letter states the issue, affected lots to be segregated and to discontinue use of. A Bard Electrophysiology Territory Manager will retrieve affected product.

    Distribution

    MA

    Quantity

    140