Class 2 Device Recall Boston Scientific Synchro 14 Guidewire

• Date Initiated by Firm: June 07, 2010
• Date Posted: January 07, 2011
• Recall Status: Terminated on January 10, 2011
• Recall Number: Z-0879-2011
• Recall Event ID: 56388
• 510(K)Number: K050964
• Product Classification: Wire, guide, catheter - Product Code DQX
• Product: Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 45 cm tip;; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119; Product is distributed by Boston Scientific Corporation, ; Fremont, CA ; The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures.
• Code Information: Material # M00313320: lot/use by dates: B17854 9/30/2011 B19301 3/31/2012
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 47900 Bayside Pkwy; Fremont CA 94538-6515
• For Additional Information Contact: Deborah Springer; 800-845-4598
• Manufacturer Reason for Recall: The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system.
• FDA Determined Cause: Other
• Action: Boston Scientific Corporation sent an Urgent Medical Device Recall letter dated June 7, 2010, by Federal Express to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use of and segregate the affected product. Complete and return the Reply Verification Tracking Form even if they did not have any affected product. Contact the Customer Service Call Center to obtain a Returned Goods Authorization (RGA) Number at (800) 811-3211, Option #1. E-mail or Fax the completed and signed Reply Verification Tracking Form to email Bob.Ware@bsci.com or the Field Action Fax (510) 624-2475. PackageShip and return the affected product along with the original Reply Verification Tracking Form by Federal Express to: Boston Scientific Corporation US Distribution Center Boston Scientific Marina Bay Customer Fulfillment Center 500 Commander Shea Blvd. Quincy, Massachusetts 02171 RGA: ____________ For questions regarding this recall call (510) 624-2563.
• Quantity in Commerce: 36,049 total units, all sizes
• Distribution: Worldwide Distribution - USA including CA, CO, IN, MD, MI, OR, TX, and VA and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Great Britian, Greece, Honduras, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Korea, Sweden, Switzerland, Thailand, Tunisia, Turkey, and Ukraine.
• 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 = DQX and Original Applicant = BOSTON SCIENTIFIC - PRECISION VASCULAR