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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific /Microvasive

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  Class 2 Device Recall Boston Scientific /Microvasive see related information
Date Initiated by Firm April 16, 2003
Date Posted May 14, 2003
Recall Status1 Terminated 3 on July 20, 2004
Recall Number Z-0821-03
Recall Event ID 26136
510(K)Number K010068  
Product Classification Prosthesis, Esophageal - Product Code ESW
Product Polyflex Esophageal Stent 23/18mm x 90mm
Code Information Reorder Number: M00514300 Lot Numbers: 03101, 03071
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Boston Scientific Place
Natick MA 01760
For Additional Information Contact Robert T. Miragliulo
508-652-35186
Manufacturer Reason
for Recall		 Radiopaque marker bands may not be visible under fluoroscopy
FDA Determined
Cause 2		 Other
Action Boston Scientific notified domestic accounts by letter on April 16, 2003. The account wasinstructed to check inventory and return product. A Reply Verification form was provided to document amount of product in inventory.
Quantity in Commerce 11
Distribution 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 = ESW and Original Applicant = RUSCH INTL.
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