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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Clipping Device, Resolution Clip

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  Class 2 Device Recall Boston Scientific Clipping Device, Resolution Clip see related information
Date Initiated by Firm June 17, 2009
Date Posted September 02, 2009
Recall Status1 Terminated 3 on October 08, 2010
Recall Number Z-1896-2009
Recall Event ID 52565
510(K)Number K040148  
Product Classification Endoscopic Clipping Device - Product Code FHN
Product Boston Scientific Clipping Device, Resolution Clip, working length 235 cm, working channel 2.8 mm, Manufactured for Boston Scientific Corporation, Natick, MA; Product codes M00522610 (1 clip) and M00522612 (20 clips).

The Resolution Clip Device is a pre-loaded single-use clip on a flexible delivery system. It is placed into the gastrointestinal tract for the purpose of endoscopic marking, hemostasis, anchoring jejunal tubes and closure of lumenal perforations.
Code Information Product code M00522610, lots 0ML9042004, 0ML9042101, 0ML9042102, 0ML9042702, 0ML9050401 and 0ML9051201. Product code M00522612, lots 0ML9042005, 0ML9042006, 0ML9042204, 0ML9042705, 0ML9042706, 0ML9050402, 0ML9050403, 0ML9051205 and 0ML9051206.
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
500 Commander Shea Blvd
Quincy MA 02171-1518
For Additional Information Contact
800-272-3737
Manufacturer Reason
for Recall		 The clip may not deploy or, if deployed, the clip may not release from the tissue.
FDA Determined
Cause 2		 Process control
Action Consignees were notified by an "Urgent Recall Letter " dated June 17, 2009 and instructed to cease using the product because the calibration of equipment used to manufacture these products was not in control. This may potentially result in an inability to deploy or release the clip from the catheter. Consignees were instructed to return a business reply form for return authorization. Please contact Cindy Finney, Field Action Team Lead at 1-508-683-4678 for assistance.
Quantity in Commerce 4269
Distribution Nationwide, France, Germany, Great Britain, Italy, Netherlands, Spain and Sweden.
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 CORP.
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