Boston Scientific brand Synchro.14" Guide Wire, 200 cm length, 35 cm tip; Boston Scientific Corporation: Made in 2405 We

FDA device recall Z-0880-2011 · posted 2011-01-07 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

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.

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.

Root cause

Other

Status

Terminated

Product code

DQX

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

Date initiated

2010-06-07

Date posted

2011-01-07

Date terminated

2011-01-10

Location

Fremont, CA

Related 510(k) clearances