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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 Scientificsee related information
Date Initiated by FirmJuly 22, 2005
Date PostedSeptember 02, 2005
Recall Status1 Terminated 3 on June 20, 2007
Recall NumberZ-1474-05
Recall Event ID 32694
510(K)NumberK030083 
Product Classification Catheter, Suprapubic (And Accessories) - Product Code KOB
ProductVaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Mini/T/PU/8/1.6/2.6/63 Catalog Number : 45-220
Code Information Lot Numbers: 919480 924195 924850 929107  932116 936291 938095 940273 943742 945847 946253 958508  958814 959674 968282 969954 971538 973971 977485 979329  985139 986238 1001735 1001736 1001737 1003619 1004053 1007397 959674D 969954D  
FEI Number 3001451463
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Boston Scientific Pl
Natick MA 01760-1536
For Additional Information ContactCindy 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
ActionBoston 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.
DistributionNationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KOB
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