—#96165

Product

Boston Scientific brand Synchro.14" Guide Wire, 200 cm length, 35 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.

FDA product code: DQX — Wire, Guide, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K050964
Affected lot / code info: Material # M00313410: lot/use by dates: B17209 7/31/2011 B19510 4/30/2012

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 47900 Bayside Pkwy, Fremont, California 94538-6515

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-06-07
Posted by FDA: 2011-01-07
Terminated: 2011-01-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96165. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.