Recall Z-1017-2013 ยท DQX Wire, Guide, Catheter
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta.
| Date | Mar 28, 2013 (initiated Mar 13, 2013) |
| Status | Terminated |
| Reason | Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Stiff Guidewire, model ARCSJ200W, where the PTFE (Teflon) coating has the potential to separate from the wire during in-vivo use. |
| Root cause | Mixed-up of materials/components |
| Action | Medtronic sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Medtronic requested any unused guidewires from the lot number to be quarantined, and returned by contacting the customer service phone number at 1-888-283-7868. A Customer Confirmation Certificate was requested to be faxed back to Medtronic at 651-367-0612. |
| Quantity | 225 units |
| Distribution | Worldwide Distribution-USA including the states of FL, OH, and MN and the countries of Belgium, France Germany, Netherlands, Turkey, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101339 | ARCHER SUPER STIFF GUIDEWIRES Medtronic, Inc., Aug 31, 2010 |