Recall Z-0263-2014 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Medtronic Vascular
THUNDER Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, THNDR300S 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 steer
| Date | Nov 15, 2013 (initiated Oct 21, 2013) |
| Status | Terminated |
| Reason | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. |
| Root cause | 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 confirmin |
| Quantity | 58 |
| 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, Australi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970466 | RADIUS PTCA GUIDEWIRE Radius Medical Technologies, Inc., May 20, 1997 |