Recall Z-3056-2011 ยท FHN Ligator, Hemorrhoidal
Boston Scientific Corporation
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 feed
| Date | Aug 22, 2011 (initiated Jul 19, 2011) |
| Status | Terminated |
| 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the clip, resulting in tissue trauma, increased bleeding and the clip being pulled off tissue as the delivery system is withdrawn. |
| Root cause | Other |
| 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, M |
| Quantity | 14, 093 boxes of both 155 cm and 235 cm size clips |
| Distribution | Worldwide Distribution - including USA (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102764 | RESOLUTION II CLIP Boston Scientific Corporation, Dec 22, 2010 |