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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Synchro 2 Guidewire

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 Class 2 Device Recall Boston Scientific Synchro 2 Guidewiresee related information
Date Initiated by FirmJune 07, 2010
Date PostedJanuary 07, 2011
Recall Status1 Terminated 3 on January 10, 2011
Recall NumberZ-0874-2011
Recall Event ID 56388
510(K)NumberK053268 
Product Classification Wire, guide, catheter - Product Code DQX
ProductBoston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Standard; 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.
Code Information Material # M00326510: lot/use by dates: B17289 7/31/2011  B17666 9/30/2011  B17720 9/30/2011  B17936 10/31/2011  B17990 10/31/2011  B18196 11/30/2011  B18197 11/30/2011  B18254 11/30/2011  B18442 12/31/2011  B18745 1/31/2012  B18811 1/31/2012  B18836 1/31/2012  B18946 2/29/2012  B19183 2/29/2012  B19307 3/31/2012      
Recalling Firm/
Manufacturer
Boston Scientific Corporation
47900 Bayside Pkwy
Fremont CA 94538-6515
For Additional Information ContactDeborah Springer
800-845-4598
Manufacturer 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 Determined
Cause 2
Other
ActionBoston 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.
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DQX
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