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U.S. Department of Health and Human Services

Class 2 Device Recall Contour VL Ureteral Stent Set

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  Class 2 Device Recall Contour VL Ureteral Stent Set see related information
Date Initiated by Firm November 16, 2020
Create Date December 30, 2020
Recall Status1 Open3, Classified
Recall Number Z-0758-2021
Recall Event ID 86880
510(K)Number K974541  
Product Classification Stent, ureteral - Product Code FAD
Product Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
Code Information GTIN 08714729423768: Lots 25928323, 25928324.   GTIN 08714729423829: Lots  25928325, 25928326, 25933063, 25933064, 25933065.   GTIN 08714729772743: Lot 25965814.   GTIN 08714729765837: Lot 25966020.
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
300 Boston Scientific Way
Marlborough MA 01752-1291
For Additional Information Contact Nicole Pshon
763-494-1133
Manufacturer Reason
for Recall		 Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.
FDA Determined
Cause 2		 Process design
Action On November 16, 2020, the firm distributed Urgent Medical Device Removal letters to affected customers. Customers were informed of the product issue and asked to take the following actions: - Verify whether you have any product from the affected lots/batches within your inventory - Immediately cease use or distribution of any remaining unused product from the affected lots/batches - Segregate affected material and return it to BSC in accordance with removal instructions included in the letter. - Distributors should forward the notification to their customers Your local Sales Representative can answer any questions that you may have regarding this notification.
Quantity in Commerce 458 units
Distribution Distribution US nationwide and Japan.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FAD and Original Applicant = BOSTON SCIENTIFIC CORP.
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