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U.S. Department of Health and Human Services

Class 2 Device Recall Synchro 2 Guidewire

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 Class 2 Device Recall 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-0868-2011
Recall Event ID 56388
510(K)NumberK053268 
Product Classification Wire, guide, catheter - Product Code DQX
ProductBoston 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 neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures. Product is distributed by Boston Scientific Corporation, Fremont, CA
Code Information Material Number M00326010 Lot/Best By date: B18002 10/31/2011 B18810 1/31/2012 B18112 10/31/2011  B18113 10/31/2011  B18114 10/31/2011  B18192 11/30/2011  B18193 11/30/2011  B18194 11/30/2011  B18195 11/30/2011  B18255 11/30/2011  B18256 11/30/2011  B18257 11/30/2011  B18258 11/30/2011  B18262 11/30/2011  B18263 11/30/2011  B18264 11/30/2011  B18265 11/30/2011  B18314 11/30/2011  B18434 12/31/2011  B18435 12/31/2011  B18436 12/31/2011  B18437 12/31/2011  B18438 12/31/2011  B18439 12/31/2011  B18471 12/31/2011  B18472 12/31/2011  B18473 12/31/2011  B18474 12/31/2011  B18475 12/31/2011  B18476 12/31/2011  B18477 12/31/2011  B18531 12/31/2011  B18532 12/31/2011  B18533 12/31/2011  B18700 12/31/2011  B18737 1/31/2012  B18738 1/31/2012  B18739 1/31/2012  B18775 1/31/2012  B18776 1/31/2012  B18806 1/31/2012  B18807 1/31/2012  B18808 1/31/2012  B18809 1/31/2012  B18810 1/31/2012 B18837 1/31/2012  B18838 1/31/2012  B18839 1/31/2012  B18840 1/31/2012  B18933 1/31/2012  B18985 3/31/2012  B18986 2/29/2012  B19052 2/29/2012  B19053 2/29/2012  B19119 2/29/2012  B19181 3/31/2012  B19186 3/31/2012  B19343 3/31/2012  B19344 3/31/2012  B17178 7/31/2011  B17179 7/31/2011  B17180 7/31/2011  B17181 7/31/2011  B17182 7/31/2011  B17183 7/31/2011  B17321 8/31/2011  B17322 8/31/2011  B17323 8/31/2011  B17324 8/31/2011  B17325 8/31/2011  B17326 8/31/2011 B17386 8/31/2011 B17387 8/31/2011 B17388 8/31 2011 B17389 8/31/2011  B17438 8/31/2011  B17439 8/31/2011  B17466 8/31/2011  B17467 8/31/2011  B17468 8/31/2011  B17505 8/31/2011  B17506 8/31/2011  B17599 9/30/2011  B17600 9/30/2011  B17601 9/30/2011  B17657 9/30/2011  B17658 9/30/2011  B17659 9/30/2011  B17660 9/30/2011  B17661 9/30/2011  B17662 9/30/2011  B`7663 9/30/2011  B17707 9/30/2011  B17708 9/30/2011  B17709 9/30/2011  B17710 9/30/2011  B17711 9/30/2011  B17712 9/30/2011  B17713 9/30/2011  B17820 10/31/2011  B17821 10/31/2011  B17822 10/31/2011  B17823 10/31/2011  B17824 10/31/2011  B17912 9/30/2011  B17923 10/31/2011  B17924 10/31/2011  B17925 10/31/2011  B17926 10/31/2011  B17927 10/31/2011  B17928 10/31/2011  B17929 10/31/2011  B17978 10/31/2011  B17979 10/31/2011  B17980 10/31/2011  B17981 10/31/2011  B17982 10/31/2011  B17983 10/31/2011  B18000 10/31/2011  B18001 10/31/2011  B17203 7/31/2011  B17204 7/31/2011  B17205 7/31/2011  B17206 7/31/2011  B17207 7/31/2011  B17276 7/31/2011  B17277 7/31/2011  B17278 7/31/2011  B17279 7/31/2011  B17280 7/31/2011  B17516 8/31/2011  B17517 8/31/2011  B17518 8/31/2011  B17519 8/31/2011  B17520 8/31/2011  B17588 8/31/2011  B17589 8/31/2011  B17590 8/31/2011  B17591 8/31/2011  B17592 9/30/2011  B17593 9/30/2011  B17812 9/30/2011  B17813 9/30/2011  B17814 9/30/2011  B17815 9/30/2011  B17816 9/30/2011  B17862 9/30/2011  B17863 9/30/2011  B17864 9/30/2011  B17865 9/30/2011  B17866 9/30/2011  B17867 9/30/2011  B18011 10/31/2011  B18012 10/31/2011  B18013 10/31/2011  B18014 10/31/2011  B18015 10/31/2011  B18016 10/31/2011  B18101 10/31/2011  B18102 10/31/2011  B18103 10/31/2011  B18104 10/31/2011  B18105 10/31/2011  B18330 11/30/2011    
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.
Quantity in Commerce36,049 units total - all sizes
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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