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U.S. Department of Health and Human Services

Class 3 Device Recall Boston Scientific Flexima Biliary Stent System

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  Class 3 Device Recall Boston Scientific Flexima Biliary Stent System see related information
Date Initiated by Firm April 02, 2008
Date Posted September 11, 2008
Recall Status1 Terminated 3 on September 11, 2008
Recall Number Z-2105-2008
Recall Event ID 48440
510(K)Number K965147  
Product Classification Catheter, biliary, diagnostic - Product Code FGE
Product Boston Scientific Flexima Biliary Stent System, 200 cm long, .035" (0.89 mm), sterile, Boston Scientific, Spencer, IN; REF 3921, UPN M00539210.

System is used 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 Lot 11374425.
Recalling Firm/
Manufacturer		 Boston Scientific Corp
780 Brookside Dr
Spencer IN 47460-1080
For Additional Information Contact
866-868-4004
Manufacturer Reason
for Recall		 Rapid Exchange Biliary Stent may be mislabeled as Flexima biliary Stent, which has a different delivery system included in the package.
FDA Determined
Cause 2		 Packaging process control
Action An Urgent Medical Device Recall-Immediate Action Required letter was sent to consignees on 4/2/08 directing them to immediately discontinue use of and segregate the identified products for return to the firm and complete the verification tracking form.
Quantity in Commerce 80
Distribution Class III Recall - Worldwide Distribution --- including USA and countries of Finland, France, Germany and Great Britain.
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 = FGE and Original Applicant = BOSTON SCIENTIFIC CORP.
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