Recall Z-0868-2011 ยท DQX Wire, Guide, Catheter
Boston Scientific Corporation
Boston Scientific brand Synchro 2 Guidewire, 0.14" 200 cm Soft. Boston Scientific; Made in: 2405 West Orton Circle, West Valley City, UT 84119 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 neurovas
| Date | Jan 7, 2011 (initiated Jun 7, 2010) |
| Status | Terminated |
| Reason | 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 | 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 Re |
| Quantity | 36,049 units total - 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, Isr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053268 | PVS 2000 SYNCHRO2 GUIDEWIRE Boston Scientific - Precision Vascular, Mar 13, 2006 |