Class 1 Device Recall XCelerator Hydrophilic Exchange Guidewire

• Date Initiated by Firm: October 05, 2016
• Date Posted: November 09, 2016
• Recall Status: Terminated on October 11, 2017
• Recall Number: Z-0310-2017
• Recall Event ID: 75358
• PMA Number: P100018
• Product Classification: Wire, guide, catheter - Product Code DQX
• Product: X-Celerator Hydrophilic Exchange Guidewire; ; Catalog No.; 103-0601-300; 103-0601-350V10; 103-0602-350V06; 103-0601-300V01; 103-0602-300; 103-0602-350V09; 103-0601-300V02; 103-0602-300V01; 103-0602-350V10; 103-0601-300V03; 103-0602-300V02; 103-0601-300V06; 103-0602-300v06; 103-0601-300V10; 103-0602-300V09; 103-0601-300V11; 103-0602-300V10; 103-0601-350; 103-0602-350; 103-0601-350V01; 103-0602-350V01; 103-0601-350V06; 103-0602-350V02
• Code Information: 9530849 9709603 9797735 A002136 A043280 A123449 A183571 9530851 9743324 9802698 A002460 A043281 A123450 A185838 9531882 9743328 9802700 A002610 A043969 A123452 A185841 9567732 9746399 9848318 A004560 A044251 A134837 A194324 9585211 9746403 9882269 A004561 A044252 A136164 A194327 9585247 9750614 9931088 A005008 A097470 A136165 A195347 9585249 9750615 9931089 A005011 A097472 A142394 A200386 9585282 9750618 9931093 A005477 A097473 A142395 A200387 9585283 9750619 9979485 A005478 A097474 A145004 A202560 9594629 9750621 9979495 A006080 A097475 A136161 A202563 9601922 9750624 9979497 A006171 A097476 A145006 A211246 9601924 9751548 9979498 A006176 A097477 A145149 A211248 9612762 9767048 9979500 A006182 A114384 A145150 A217138 9612763 9794407 201401398X A006887 A114385 A145152 A217141 9628372 9794409 201601079E A008199 A114389 A145153 A217142 9641711 9794795 201602502E A008201 A114391 A150759 A221040 9643550 9794924 201603429E A014137 A114393 A150762 A221041 9660868 9794925 201603430E A014297 A114543 A150764 A221042 9666144 9795119 201605381E A014819 A114545 A151577 A221043 9666146 9795120 201605382E A014821 A114546 A152854 A237364 9666148 9795516 201605383E A014825 A115726 A152856 A237366 9666835 9795517 201605384E A019031 A116267 A159822 A237368 9667132 9796816 201606174E A019337 A116270 A159826 A243986 9690683 9796817 201606178E A035856 A116271 A165319 A243987 9690686 9796817 201606179E A035858 A116272 A165320 A243988 9690687 9796818 201606180E A037439 A116274 A165321 A247255 9701004 9797467 201606297E A040174 A123439 A183549 A247256 9702147 9797469 201606298E A040176 A123440 A183550 A247259 9706211 9797470 A002129 A040177 A123442 A183561 A247270 9709599 9797734 A002131 A040222 A123445 A183563 A258089
• Recalling Firm/ Manufacturer: Micro Therapeutics Inc, Dba Ev3 Neurovascular; 9775 Toledo Way; Irvine CA 92618-1811
• For Additional Information Contact: 949-837-3700
• Manufacturer Reason for Recall: Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
• FDA Determined Cause: Device Design
• Action: Medtronic sent an Urgent Medical Device Recall letter dated October 5, 2016, to all affected customers to inform them that Medtronic has identified the potential for an issue with a specific set of lot numbers of Medtronic Neurovascular products as noted where the PTFE (polytetrafluoroethylene) coating could delaminate and separate from the delivery wire. Customers are instructed to complete the attached customer confirmation certificate and fax it to Medtronic at (949) 434-5020 to the attention of Neurovascular Quality. On October 14, 2016, Medtronic announced that it has notified customers of a voluntary recall of certain lots of its Pipeline embolization device, Alligator retrieval device and X-Celerator hydrophilic guidewire. The recall also includes the stylet containing UltraFlow flow directed micro catheters and Marathon flow directed micro catheters. This voluntary recall is being conducted due to the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of these devices. Should the PTFE separate from the delivery wire or stylets, PTFE particulate could enter the blood stream of the patient. PTFE in the blood stream, based on the size and quantity, could lead to a thromboembolic event. Customers were asked to complete the attached Customer Confirmation Certificate and fax it to Medtronic at 1-949-434-5020 to the attention of Neurovascular Quality. Customers with questions were instructed to contact their Medtronic representative. On 1/12/17, an Urgent Medical Device Recall letter was sent to expand the recall to include additional lots.
• Quantity in Commerce: 10,516 units
• Distribution: Worldwide Distribution - US (nationwide) and Internationally to Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Nepal, Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Russian Federation, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
• Total Product Life Cycle: TPLC 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.