• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Resolution II Clip

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall Resolution II Clip see related information
Date Initiated by Firm July 19, 2011
Date Posted August 22, 2011
Recall Status1 Terminated 3 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/
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact Cindy Finney
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 2
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