Recall Z-0265-2014 ยท DQX Wire, Guide, Catheter
Medtronic Vascular
ATTAIN HYBRID Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.
| 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 | 1674 |
| 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
| K063210 | ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488 Medtronic Inc. Cardiac Rhythm Management, Mar 15, 2007 |