Boston Scientific brand Synchro.14" Guide Wire, 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.
- Company
- Boston Scientific Corporation
- Recall Initiated
- June 7, 2010
- Posted
- January 7, 2011
- Terminated
- January 10, 2011
- Recall Number
- Z-0876-2011
- Quantity
- 36, 039 total units - all sizes
- Firm Location
- Fremont, CA
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.
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.
Lot / Code Info
Material # M00313010: lot/use by dates: B18331 11/30/2011 B18332 11/30/2011 B18333 11/30/2011 B18334 11/30/2011 B18335 11/30/2011 B18383 11/30/2011 B18384 11/30/2011 B18385 11/30/2011 B18386 11/30/2011 B18387 11/30/2011 B18388 11/30/2011 B18389 11/30/2011 B18544 12/31/2011 B18545 12/31/2011 B18546 12/31/2011 B18547 12/31/2011 B18548 12/31/2011 B18549 12/31/2011 B18650 12/31/2011 B18651 12/31/2011 B18652 12/31/2011 B18653 12/31/2011 B18654 12/31/2011 B18655 12/31/2011 B18656 12/31/2011 B18657 12/31/2011 B18843 1/31/2012 B18844 1/31/2012 B18845 1/31/2012 B18887 1/31/2012 B18888 1/31/2012 B18889 1/31/2012 B18890 1/31/2012 B18891 1/31/2012 B18897 1/31/2012 B18898 1/31/2012 B18899 1/31/2012 B18900 1/31/2012 B18901 1/31/2012 B18902 1/31/2012 B19094 2/29/2012 B19095 2/29/2012 B19106 2/29/2012 B19107 2/29/2012 B19108 2/29/2012 B19233 3/31/2012 B19235 3/31/2012 B19240 3/31/2012 B19298 3/31/2012 B19299 3/31/2012 B19389 3/31/2012 B19390 4/30/2012 B19454 4/30/2012 B19466 4/30/2012 .
Root Cause
Other
Action Taken
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.