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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-0735-03
Recall Event ID 25812
510(K)Number K830840  
Product Classification Catheter, Urethral - Product Code GBM
Product Boston Scientific/Microvasive Open End Ureteral Catheter (5 Fr x 70 cm)
Product Number: 400-201
Code Information Lot Numbers: 5178078 5180218 5195624 5198454 5202074 5205547 5208877 5215596 5218848 5225787 5228124 5229087 5230642 5238639 5241768 5243189 5243189 5243190 5246163 5252047 5252048 5252049 5253538 5256810 5259786 5269989 5291570 5303658 5315933 5315934 5326181 5326182 5327127 5331373 5334828 5337025 5337026 5337026 5344010 5345288 5355951 5358877 
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 293 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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