Class 2 Device Recall Boston Scientific

• Date Initiated by Firm: December 20, 2006
• Date Posted: March 13, 2007
• Recall Status: Terminated on December 12, 2007
• Recall Number: Z-0609-2007
• Recall Event ID: 37068
• 510(K)Number: K964119
• Product Classification: Wallstent Endoscopic Biliary Endoprosthesis- - Product Code FGE
• Product: Wallstent Endoscopic Biliary Endoprosthesis 10mm x 80mm, UPN H965430600
• Code Information: Lot Numbers: 7889257, 7892749, 7924670, 7924672, 7944542, 7948443, 7948444, 7959299, 7959300, 7975078, 7975079, 7979468, 7979469, 7991051, 7991054, 7998758, 7998759, 7998760, 8002684, 8002685, 8014025, 8041040, 8041041, 8041222, 8052772, 8052774, 8060259, 8071855, 8071856, 8075138, 8080170, 8093632, 8109650, 8109651, 8114689, 8117678, 8131078, 8151476, 8155398, 8166781, 8170747, 8174687, 8174689, 8187008, 8191493, 8206779, 8206780, 8211778, 8211779, 8214766, 8226828, 8230827, 8230830, 8231159, 8268293, 8272150, 8272151, 8284684, 8284685, 8290955, 8306944, 8319230, 8319231, 8339003, 8339005, 8343275, 8343279, 8347008, 8367859, 8367860, 8367861, 8385775, 8385776, 8385777, 8389894, 8389895, 8401051, 8406650, 8406651, 8406652, 8427648, 8427649, 8431394, 8449739, 84623248, 8466568, 8466569, 8466570, 8474529, 8474530, 8474531, 8482833, 8486629, 8486630, 8486631, 8503298, 8503299, 8503300, 8505352, 8505353, 8505354, 8505355, 8505356, 8505357, 8505358, 8505359, 8505360, 8505361, 8505362, 8505363, 8505364, 8507020, 8511088, 8526132, 8526135, 8547345, 8547346, 8551223, 8551224, 8567704, 8571917, 8571918, 8571919, 8583897, 8583898, 8583899, 8591867, 8611580, 8611581, 8614222, 8648847, 8648849, 8648850, 8655868, 8655869, 8683744, 8688103, 8692109, 8706158, 8709576, 8709923, 8709975, 8724559, 8724560, 8727932, 8727933, 8752575, 8766341, 8766342, 8775286, 8775287, 8810553, 8810554, 8810570, 8814730, 8815105, 8844670, 8844671, 8844872, 8849235, 8849236, 8849237, 8853318, 8853319, 8867181, 8893397, 8898058, 8902082, 8902083, 8913833, 8935976, 8935977, 8935978, 8948215, 8976949, 9132297, 9132373, 9132374, 9132375, 9132376, 9132377, 9132378, 9132379, 9132380, 9132381, 9132382, 9132383, 9132384, 9132385, 9132386, 9132387, 9132388, 9132389
• 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: Other
• Action: On 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 Commerce: 8,511 for Recalls Z-0604-0609-2007
• Distribution: Worldwide 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 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 = FGE and Original Applicant = BOSTON SCIENTIFIC SCIMED, INC.