{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "93381", "product_res_number": "Z-0868-2011", "event_date_initiated": "2010-06-07", "event_date_posted": "2011-01-07", "recall_status": "Terminated", "event_date_terminated": "2011-01-10", "res_event_number": "56388", "product_code": "DQX", "k_numbers": [ "K053268" ], "product_description": "Boston Scientific brand Synchro 2 Guidewire, 0.14\" 200 cm Soft. \nBoston Scientific; Made in: 2405 West Orton Circle, West Valley City, UT 84119 \nThe 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. \n\n\nProduct is distributed by Boston Scientific Corporation, \nFremont, CA", "code_info": "Material Number M00326010 Lot/Best By date: B18002 10/31/2011 B18810 1/31/2012 B18112 \t10/31/2011  B18113 \t10/31/2011  B18114 \t10/31/2011  B18192 \t11/30/2011  B18193 \t11/30/2011  B18194 \t11/30/2011  B18195 \t11/30/2011  B18255 \t11/30/2011  B18256 \t11/30/2011  B18257 \t11/30/2011  B18258 \t11/30/2011  B18262 \t11/30/2011  B18263 \t11/30/2011  B18264 \t11/30/2011  B18265 \t11/30/2011  B18314 \t11/30/2011  B18434 \t12/31/2011  B18435 \t12/31/2011  B18436 \t12/31/2011  B18437 \t12/31/2011  B18438 \t12/31/2011  B18439 \t12/31/2011  B18471 \t12/31/2011  B18472 \t12/31/2011  B18473 \t12/31/2011  B18474 \t12/31/2011  B18475 \t12/31/2011  B18476 \t12/31/2011  B18477 \t12/31/2011  B18531 \t12/31/2011  B18532 \t12/31/2011  B18533 \t12/31/2011  B18700 \t12/31/2011  B18737 \t1/31/2012  B18738 \t1/31/2012  B18739 \t1/31/2012  B18775 \t1/31/2012  B18776 \t1/31/2012  B18806 \t1/31/2012  B18807 \t1/31/2012  B18808 \t1/31/2012  B18809 \t1/31/2012  B18810 1/31/2012 B18837 \t1/31/2012  B18838 \t1/31/2012  B18839 \t1/31/2012  B18840 \t1/31/2012  B18933 \t1/31/2012  B18985 \t3/31/2012  B18986 \t2/29/2012  B19052 \t2/29/2012  B19053 \t2/29/2012  B19119 \t2/29/2012  B19181 \t3/31/2012  B19186 \t3/31/2012  B19343 \t3/31/2012  B19344 \t3/31/2012  B17178 \t7/31/2011  B17179 \t7/31/2011  B17180 \t7/31/2011  B17181 \t7/31/2011  B17182 \t7/31/2011  B17183 \t7/31/2011  B17321 \t8/31/2011  B17322 \t8/31/2011  B17323 \t8/31/2011  B17324 \t8/31/2011  B17325 \t8/31/2011  B17326 8/31/2011 B17386 8/31/2011 B17387 8/31/2011 B17388 8/31 2011 B17389 \t8/31/2011  B17438 \t8/31/2011  B17439 \t8/31/2011  B17466 \t8/31/2011  B17467 \t8/31/2011  B17468 \t8/31/2011  B17505 \t8/31/2011  B17506 \t8/31/2011  B17599 \t9/30/2011  B17600 \t9/30/2011  B17601 \t9/30/2011  B17657 \t9/30/2011  B17658 \t9/30/2011  B17659 \t9/30/2011  B17660 \t9/30/2011  B17661 \t9/30/2011  B17662 \t9/30/2011  B`7663 \t9/30/2011  B17707 \t9/30/2011  B17708 \t9/30/2011  B17709 \t9/30/2011  B17710 \t9/30/2011  B17711 \t9/30/2011  B17712 \t9/30/2011  B17713 \t9/30/2011  B17820 \t10/31/2011  B17821 \t10/31/2011  B17822 \t10/31/2011  B17823 \t10/31/2011  B17824 \t10/31/2011  B17912 \t9/30/2011  B17923 \t10/31/2011  B17924 \t10/31/2011  B17925 \t10/31/2011  B17926 \t10/31/2011  B17927 \t10/31/2011  B17928 \t10/31/2011  B17929 \t10/31/2011  B17978 \t10/31/2011  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 \t7/31/2011  B17204 \t7/31/2011  B17205 \t7/31/2011  B17206 \t7/31/2011  B17207 \t7/31/2011  B17276 \t7/31/2011  B17277 \t7/31/2011  B17278 \t7/31/2011  B17279 \t7/31/2011  B17280 \t7/31/2011  B17516 \t8/31/2011  B17517 \t8/31/2011  B17518 \t8/31/2011  B17519 \t8/31/2011  B17520 \t8/31/2011  B17588 \t8/31/2011  B17589 \t8/31/2011  B17590 \t8/31/2011  B17591 \t8/31/2011  B17592 \t9/30/2011  B17593 \t9/30/2011  B17812 \t9/30/2011  B17813 \t9/30/2011  B17814 \t9/30/2011  B17815 \t9/30/2011  B17816 \t9/30/2011  B17862 \t9/30/2011  B17863 \t9/30/2011  B17864 \t9/30/2011  B17865 \t9/30/2011  B17866 \t9/30/2011  B17867 \t9/30/2011  B18011 \t10/31/2011  B18012 \t10/31/2011  B18013 \t10/31/2011  B18014 \t10/31/2011  B18015 \t10/31/2011  B18016 \t10/31/2011  B18101 \t10/31/2011  B18102 \t10/31/2011  B18103 \t10/31/2011  B18104 \t10/31/2011  B18105 \t10/31/2011  B18330 \t11/30/2011", "firm_fei_number": "2939204", "recalling_firm": "Boston Scientific Corporation", "address_1": "47900 Bayside Pkwy", "city": "Fremont", "state": "CA", "postal_code": "94538-6515", "additional_info_contact": "Deborah Springer\n800-845-4598", "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.", "root_cause_description": "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. \nCustomers were instructed to immediately discontinue use of and segregate the affected product. \nComplete and return the Reply Verification Tracking Form even if they did not have any affected product. \nContact the Customer Service Call Center to obtain a Returned Goods Authorization (RGA) Number at (800) 811-3211, Option #1. \nE-mail or Fax the completed and signed Reply Verification Tracking Form to \nemail Bob.Ware@bsci.com or the Field Action Fax (510) 624-2475.\nPackageShip and return the affected product along with the original Reply Verification Tracking Form by Federal Express to:\nBoston Scientific Corporation\nUS Distribution Center\nBoston Scientific Marina Bay\nCustomer Fulfillment Center\n500 Commander Shea Blvd.\nQuincy, Massachusetts 02171\nRGA: ____________\nFor questions regarding this recall call (510) 624-2563.", "product_quantity": "36,049 units total - all sizes", "distribution_pattern": "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.", "openfda": { "k_number": [ "K161887", "K955551", "K170700", "K240818", "K861115", "K063372", "K171897", "K001454", "K914194", "K863178", "K950266", "K934339", "K011905", "K141054", "K950352", "K173277", "K102211", "K112957", "K080563", "K072552", "K133230", "K160018", "K153106", "K971086", "K863138", "K011906", "K152497", "K181353", "K884198", "K030617", "K922302", "K201595", "K961015", "K083713", "K941895", 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