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U.S. Department of Health and Human Services

Class 2 Device Recall FLEXIMA Biliary Stent System

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 Class 2 Device Recall FLEXIMA Biliary Stent Systemsee related information
Date Initiated by FirmApril 27, 2010
Date PostedAugust 25, 2010
Recall Status1 Terminated 3 on March 23, 2011
Recall NumberZ-1993-2010
Recall Event ID 55855
510(K)NumberK965147 
Product Classification Catheter, biliary, diagnostic - Product Code FGE
ProductFLEXIMA Biliary Stent System, 11.5Fr-12cm, M00539380, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
Code Information 13284754
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
500 Commander Shea Blvd
Quincy MA 02171-1518
For Additional Information Contact
617-689-6000
Manufacturer Reason
for Recall		Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile.
FDA Determined
Cause 2		Packaging
ActionBoston Scientific sent an "Urgent Medical Device Recall - Immediate Action Required" letter date April 27, 2010 to all consignees. The letter included instructions to immediately discontinue use and segregate the affected product for return, and complete and return by fax a Reply Verification Tracking Form. Customers with affected product were instructed to contact customer service at 866-868-4004 to obtain a Return Authorization (RGA) number, and package and ship the product to Boston Scientific.
Quantity in Commerce0
DistributionWorldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FGE
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