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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 March 17, 2003
Date Posted April 17, 2003
Recall Status1 Terminated 3 on March 07, 2016
Recall Number Z-0737-03
Recall Event ID 25812
510(K)Number K870694  
Product Classification Catheter, Urethral - Product Code GBM
Product Boston Scientific/Microvasive Cone Tip Ureteral Catheter (5 Fr x 70 cm)
Product Number: 400-211
Code Information Lot Numbers: 5178119 5188905 5192526 5192527 5194308 5198455 5202075 5205549 5208875 5208878 5225910 5226327 5229088 5235251 5235252 5235253 5258360 5258361 5269990 5270281 5270281 5286299 5288682 5291571 5291572 5315936 5327922 5331374 5334829 5334830 5337023 5344015 5363071 5366442 5366443 5375808 5381688 
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Boston Scientific Place
Natick MA 01760
For Additional Information Contact Robert T. Miragliulo
508-652-5186
Manufacturer Reason
for Recall		 Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use
FDA Determined
Cause 2		 Other
Action Boston Scientific/Microvasive, Natick, MA notified domestic accounts by letter on 3/17/03. Users are requesed to check inventory and return product to Boston Scientific. A responsed form was requested to be completed. and returned by facsmile.
Quantity in Commerce 267 boxes (20 units/box)
Distribution Nationwide Foreign:Singapore, Japan, Korea, Canada, Africa
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 = GBM and Original Applicant = VAN-TEC, INC.
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