BEUDAMED
    FDA Recall Terminated

    The Resolution II Clip, 155 cm size and 235 cm size, Boxes of 1, 10, and 20 clips consists of a pre-loaded, radiopaque single use clip on a flexible delivery system. Endoscopic Clipping Device, Hemorrhoidal Ligator. The device is used for clip placement within the GI tract for hemostatis ( mucosal defects, bleeding ulcer, arteries, polyps); endoscopic marking; and anchoring to affix jejunal feeding tubes to the wall of the small bowel, as a supplementary method for closure of GI tract luminal perforation <20 mm that can be treated conservatively.

    Recall: Z-3056-2011 · Initiated July 19, 2011

    Recall

    Recall Number
    Z-3056-2011
    Event Number
    59476
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    FHN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 19, 2011
    Posted
    August 22, 2011
    Terminated
    June 22, 2012
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    Description

    The Resolution II Clip, 155 cm size and 235 cm size, Boxes of 1, 10, and 20 clips consists of a pre-loaded, radiopaque single use clip on a flexible delivery system. Endoscopic Clipping Device, Hemorrhoidal Ligator. The device is used for clip placement within the GI tract for hemostatis ( mucosal defects, bleeding ulcer, arteries, polyps); endoscopic marking; and anchoring to affix jejunal feeding tubes to the wall of the small bowel, as a supplementary method for closure of GI tract luminal perforation <20 mm that can be treated conservatively.

    Reason

    Boston Scientific has received reports where, following clip deployment, the alignment of the clip and delivery system does not allow for the withdrawal of the delivery system away from the clip, resulting in tissue trauma, increased bleeding and the clip being pulled off tissue as the delivery system is withdrawn.

    Action

    Boston Scientific sent an URGENT MEDICAL DEVICE RECALL letter dated August 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to forward the Medical Device Recall to their customers. Customers were instructed to: Immediately discontinue use of any affected product. Complete and return the Reply Verification Tracking Form by fax to 508-683-5578. Package and return any affected product to: Boston Scientific Corporation Distribution Center Attn: QA Returns 500 Commander Shea Blvd Quincy, MA 02171 For questions regarding this recall call 508-683-5578.

    Distribution

    Worldwide Distribution - including USA (nationwide)

    Quantity

    14, 093 boxes of both 155 cm and 235 cm size clips