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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 FirmDecember 20, 2006
Date PostedMarch 13, 2007
Recall Status1 Terminated 3 on December 12, 2007
Recall NumberZ-0607-2007
Recall Event ID 37068
510(K)NumberK964119 
Product Classification Wallstent Endoscopic Biliary Endoprosthesis - Product Code FGE
ProductWallstent Endoscopic Biliary Endoprosthesis 10mm x 40mm, UPN H965430400
Code Information Lot Numbers: 7928218, 7940824, 7959297, 7979465, 8016999, 8017000, 8041037, 8052775, 8093630, 8113554, 8113555, 8155386, 8155387, 8222854, 8247383, 8247384, 8247385, 8251326, 8251327, 8263403, 8263404, 8268291, 8364159, 8389892, 8423296, 8431392, 8442255, 8449736, 8490449, 8490450, 8502340, 8502341, 8502343, 8502344, 8502345, 8502346, 8503289, 8530084, 8530085, 8547344, 8603144, 8620590, 8624525, 8688101, 8688102, 8724565, 8727811, 8736211, 8797653, 8797654, 8829556, 8829557, 8831248, 8871693, 8871694, 8876235, 8876236, 8909940, 8909941, 8948216, 8948216, 8952271, 8952271, 8952432, 9131974, 9131975, 9131976, 9131977, 9131978, 9131979, 9131980
FEI Number 3001451463
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
One Boston Scientific Place
Natick MA 01760
Manufacturer Reason
for Recall		Guidewire restriction during use (excessive adhesive in the guidewire lumen)
FDA Determined
Cause 2		Other
ActionOn December 20, 2006, Boston Scientific notified all US consignees by letter sent via Fed Ex Priority mail. Customers are instructed to remove affected product from inventory and return it to Boston Scientific. The notification also requested the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product in inventory. Boston Scientific International Regulatory Affairs was notified and is responsible the monitoring foreign recall.
Quantity in Commerce8,511 for Recalls Z-0604-0609-2007
DistributionWorldwide distribution --- USA and countries of Austria, Belgium, France, Czech Republic, Germany, great Britain, Greece,Ireland, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Spain, Switzerland, and Sweden.
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 = FGE
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