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U.S. Department of Health and Human Services

Class 1 Device Recall XCelerator Hydrophilic Exchange Guidewire

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  Class 1 Device Recall XCelerator Hydrophilic Exchange Guidewire see related information
Date Initiated by Firm October 05, 2016
Date Posted November 09, 2016
Recall Status1 Terminated 3 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.
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Recalling Firm/
Micro Therapeutics Inc, Dba Ev3 Neurovascular
9775 Toledo Way
Irvine CA 92618-1811
For Additional Information Contact
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 2
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.