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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific

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  Class 2 Device Recall Boston Scientific see related information
Date Initiated by Firm July 22, 2005
Date Posted September 02, 2005
Recall Status1 Terminated 3 on June 20, 2007
Recall Number Z-1473-05
Recall Event ID 32694
510(K)Number K030083  
Product Classification Catheter, Suprapubic (And Accessories) - Product Code KOB
Product Vaxcel¿ Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Mini/T/PU/8/1.6/2.6/63
Catalog Number : 45-215
Code Information Lot Numbers:  904298 907475 916189 916193 916670 916671 917024 919478 919479 919973 920314 920761  922593 922982 924194 924849 926889 927902 927903 928721 931395 932992 933282 933688 937477 939043 939459 939785  940272 940576 943741 944476 944968 958507 968281 968733  969953 970275 973166 973517 974967 979015 979016 979610  985138 986235 986236 986237 1001730 1001731 1001732 1001733 1001734 1002346 1002347 1002348 1002349 1002766 1004052 958507D 968281D 968733D  
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Boston Scientific Pl
Natick MA 01760-1536
For Additional Information Contact Cindy Finney
508-683-4678
Manufacturer Reason
for Recall		 The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
FDA Determined
Cause 2		 Other
Action Boston Scientific intiated the recall on 7/22/05 to direct accounts and to distributors on 7/ 27 /05. Distributors are requested to conduct sub recalls to the medical facility level. A revised letter dated 8/2/05 was sent to 18 US accounts for one lot (#1020895) omitted in the letter of 7/22/05.
Distribution Nationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula
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 = KOB and Original Applicant = BOSTON SCIENTIFIC CORP.
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