{ "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": "96155", "product_res_number": "Z-0872-2011", "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 Synchro2 0.14\" Guide Wire, 200 cm, Standard;\nBoston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119\nProduct is distributed by Boston Scientific Corporation, \nFremont, CA \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.", "code_info": "Material # M00326410: lot/use by dates: B17096 \t7/31/2011  B17097 \t7/31/2011  B17098 \t7/31/2011  B17099 \t7/31/2011  B17185 \t7/31/2011  B17186 \t7/31/2011  B17187 \t7/31/2011  B17188 \t7/31/2011  B17198 \t7/31/2011  B17199 \t7/31/2011  B17287 \t7/31/2011  B17288 \t7/31/2011  B17327 \t8/31/2011  B17328 \t8/31/2011  B17329 \t8/31/2011  B17330 \t8/31/2011  B17331 \t8/31/2011  B17390 \t8/31/2011  B17391 \t8/31/2011  B17392 \t8/31/2011  B17393 \t8/31/2011  B17394 \t8/31/2011  B17469 \t8/31/2011  B17470 \t8/31/2011  B17472 \t8/31/2011  B17473 \t8/31/2011  B17474 \t8/31/2011  B17504 \t8/31/2011  B17507 \t8/31/2011  B17508 \t8/31/2011  B17509 \t8/31/2011  B17510 \t8/31/2011  B17602 \t9/30/2011  B17664 \t9/30/2011  B17665 \t9/30/2011  B17714 \t9/30/2011  B17715 \t9/30/2011  B17716 \t9/30/2011  B17717 \t9/30/2011  B17718 \t9/30/2011  B17719 \t9/30/2011  B17825 \t10/31/2011  B17826 \t10/31/2011  B817851 \t9/30/2011  B17931 \t10/31/2011  B17932 \t10/31/2011  B17933 \t10/31/2011  B17934 \t10/31/2011  B17984 \t10/31/2011  B17985 \t10/31/2011  B17986 \t10/31/2011  B17987 \t10/31/2011  B18003 \t10/31/2011  B18004 \t10/31/2011  B18082 \t10/31/2011  B18198 \t11/30/2011  B18200 \t11/30/2011  B18201 \t11/30/2011  B18202 \t11/30/2011  B18259 11/30/2011 B18260 \t11/30/2011  B18261 \t11/30/2011  B18266 \t11/30/2011  B18267 \t11/30/2011  B18268 \t11/30/2011  B18315 \t11/30/2011  B18316 \t11/30/2011  B18317 \t11/30/2011  B18318 \t11/30/2011  B18319 \t11/30/2011  B18394 \t12/31/2011  B18444 \t12/31/2011  B18445 \t12/31/2011  B18446 \t12/31/2011  B18447 \t12/31/2011  B18448 \t12/31/2011  B18449 \t12/31/2011  B18479 \t12/31/2011  B18480 \t12/31/2011  B18481 \t12/31/2011  B18484 \t12/31/2011  B18535 \t12/31/2011  B18536 \t12/31/2011  B18537 \t12/31/2011  B18538 \t12/31/2011  B18701 \t12/31/2011  B18742 \t1/31/2012  B18743 \t1/31/2012  B18812 \t1/31/2012  B18813 \t1/31/2012  B18814 \t1/31/2012  B18815 \t1/31/2012  B18816 \t1/31/2012  B18841 \t1/31/2012  B18842 \t1/31/2012  B18934 \t1/31/2012  B18987 \t2/29/2012  B18988 \t2/29/2012  B19023 \t2/29/2012  B19024 \t2/29/2012  B19110 \t2/29/2012  B19120 \t2/29/2012  B19187 \t3/31/2012  B19346 \t3/31/2012  B19379 \t3/31/2012  819384 \t3/31/2012", "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 total units, 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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