Class 2 Device Recall Resolution II Clip

• Date Initiated by Firm: July 19, 2011
• Date Posted: August 22, 2011
• Recall Status: Terminated on June 22, 2012
• Recall Number: Z-3056-2011
• Recall Event ID: 59476
• 510(K)Number: K102764
• Product Classification: Ligator, hemorrhoidal - Product Code FHN
• Product: 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.
• Code Information: Catalog M00522500: Lot 1ML1013103, ML00000004, ML00000129, Catalog M00522501: Lot 1ML1013104, ML00000071, ML00000148, Catalog M00522502: Lot 1ML1013102, ML00000042, ML00000131, Catalog No. M00522501: Lot 1ML1011201, 1ML1013101, 1ML1020202, 1ML1021402, 1ML1022202, ML1022213,ML00000013, ML00000019, L00000058,ML00000073, ML00000098, ML00000120, Catalog No. M00522511: Lot 1ML1010605, 1ML1012602, 1ML1013105, 1ML1020203, 1ML1021403, 1ML1022203,1ML1022214, ML00000014, ML00000020,ML00000043, ML00000059, ML00000074,ML00000099, ML00000119, Catalog No. M00522512: Lot 1ML1011905, 1ML1020201, 1ML1021401, 1ML1022201, 1ML1022215, ML00000018,ML00000032, ML00000040, ML00000072,ML00000097, ML00000135, and ML00000137
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 100 Boston Scientific Way; Marlborough MA 01752-1234
• For Additional Information Contact: Cindy Finney; 508-683-8000
• Manufacturer Reason for Recall: 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the clip, resulting in tissue trauma, increased bleeding and the clip being pulled off tissue as the delivery system is withdrawn.
• FDA Determined 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, MA 02171 For questions regarding this recall call 508-683-5578.
• Quantity in Commerce: 14, 093 boxes of both 155 cm and 235 cm size clips
• Distribution: Worldwide Distribution - including USA (nationwide)
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FHN and Original Applicant = Boston Scientific Corporation