Z-0881-2011

Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 35 cm tip; Boston Scientific Corporation: Made...

Name: Z-0881-2011 Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 35 cm tip; Boston Scientific Corporation: Made...
Creator: Boston Scientific Corporation
Published: 2010-06-07
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2010-06-07 / Terminated

FDA source

Boston Scientific Corporation began a recall of Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 35 cm tip; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT... on 2010-06-07. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0881-2011
Status: Terminated
Initiated: 2010-06-07
Posted: 2011-01-07
Terminated: 2011-01-10
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific brand Synchro.14" Guide Wire, 300 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.
Product code: DQX Wire, Guide, Catheter
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 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 Reply Verification Tracking Form to email [email protected] 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.
Product codes and lots: Material # M00313510: lot/use by dates: B17282 7/31/2011

Product code DQX

K050964Class IIPv 1900 Synchro 0.016 GuidewireBoston Scientific - Precision Vascular / cleared 2005-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)