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U.S. Department of Health and Human Services

Class 1 Device Recall Cougar Nitinol Workhorse Guidewire

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  Class 1 Device Recall Cougar Nitinol Workhorse Guidewire see related information
Date Initiated by Firm October 21, 2013
Date Posted November 15, 2013
Recall Status1 Terminated 3 on December 15, 2014
Recall Number Z-0261-2014
Recall Event ID 66567
510(K)Number K032899  
Product Classification Wire, guide, catheter - Product Code DQX
Product Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S. CGRXT190HJ, CGRXT190HS, CGRXT190J, CGRXT190S, CGRXT300HJ, CGRXT300HS, CGRXT300J, CGRXT300S

Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
Code Information G13A00104 G13A00105 G13A00106 G13A00107 G13A00108 G13A00109 G13A00110 G13A00112 G13A00113 G13A00114 G13A00692 G13A00713 G13A00734 G13A00788 G13A00803 G13A00804 G13A00809 G13A00810 G13A00811 G13A00874 G13A00971 G13A00972 G13A00973 G13A00974 G13A00975 G13A00976 G13A00977 G13A00978 G13A00979 G13A00980 G13A00981 G13A00982 G13A01016 G13A01017 G13A01330 G13A01400 G13A01401 G13A01409 G13A01410 G13A01411 G13A01446 G13A01449 G13A01452 G13A01569 G13A01584 G13A01600 G13A01604 G13A01605 G13A01606 G13A01607 G13A01608 G13A01609 GV827 GV829 GV830 GV831 GV832 GV835 GV836 GV837 GV838 GV839 GV840 GV844 GV845 GW405 GW406 GW407 GW508 GW509 GW510 GW675 GW687 GW688 GW706 GW710 GW745 GW746 GV824 
Recalling Firm/
Manufacturer		 Medtronic Vascular
35-37A Cherry Hill Drive
Danvers MA 01923-2565
For Additional Information Contact
978-777-0042
Manufacturer Reason
for Recall		 Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, Medtronic, sent a "URGENT MEDICAL DEVICE RECALL" letter dated October 21, 2013 (in the US via UPS overnight service, 1-day delivery) to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately remove and quarantine all potentially affected guidewires that remain in inventory; return the affected product to Medtronic; if replacement product is needed, your Medtronic representative can assist you with identifying suitable replacement product, and to complete and return the Customer Confirmation Certificate confirming receipt of the notification via fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality (100% customer confirmations will be required). Should have any questions, please contact your Medtronic Representative or call 763-526-2513. Notifications to customers concerning the additional affected product began December 19, 2013 (in the US via UPS overnight service, 1-day delivery). Customers are requested to return a Confirmation Certificate confirming their receipt of the notification. 100% customer confirmations will be required from the additional consignees.
Quantity in Commerce 10,230
Distribution Worldwide distribution: US (Nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV; and countries of: Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guyana, Honduras, Hong Kong,Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mexico, Montenegro, Nepal, Netherlands, New Zealand, Nepal, Nicaragua, Norway, Oman, Poland, Portugal Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Uruguay, and Yemen.
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.
510(K) Database 510(K)s with Product Code = DQX and Original Applicant = RADIUS MEDICAL TECHNOLOGIES, INC.
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