Recall Z-1019-2013 ยท DQX Wire, Guide, Catheter
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide. Product Usage: The Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta, where increased support, distal flexibility, and low surface f
| Date | Mar 28, 2013 (initiated Mar 13, 2013) |
| Status | Terminated |
| Reason | Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W, where a change in the manufacturing process has been identified as the cause for potential kinking and breaking at the proximal weld end of the outer spring coil during in-vivo use. |
| Root cause | Component change control |
| Action | Medtronic sent an Urgent Medical Device Recall letter dated March 2013 to all affected customers. The letter identifies the affected product, problem and actions to be taken. Customers were instructed to immediately quarantine all affected products and returned to Medtronic. Customers were requested to complete the attached Customer Confirmation Certificate and fax it to Medtronic to the attention of Customer Focused Quality. For question contact your local Medtronic representative or Medtronic Customer Service at 1-888-283-7868. |
| Quantity | 27,682 devices |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Canada, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, El Salvador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Indi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101339 | ARCHER SUPER STIFF GUIDEWIRES Medtronic, Inc., Aug 31, 2010 |