Recall Z-1187-2016 ยท NEY System, Ablation, Microwave And Accessories
Covidien Medical Products (Shanghai) Manufacturing L.L.C.
Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Thermosphere" Technology; The product is packaged in a blister with a tyvek lid, contained in a display box. The numbers of units per carton is 1. Long Percutaneous Antenna with Thermosphere" Technology Product Usage: The Covidien Emprint Ablation System is intended for use in percutaneous,laparoscopic, an
| Date | Mar 17, 2016 (initiated Feb 23, 2016) |
| Status | Terminated |
| Reason | Medtronic is voluntarily recalling specific item codes and production lots of Covidien Emprint" Percutaneous Antenna with Thermosphere" Technology due to the potential for the generator to shut down in the precence of high temperature measurements in the Emprint" Percutaneous Antenna. |
| Root cause | Nonconforming Material/Component |
| Action | Medtronic sent an Urgent Medical Device Recall letter dated February 23, 2016 to all affected customers via Federal Express or Certified Mail. The letter identified the affected product, problem and actions. Customers were advised to quarantine and discontinue use of the affected product and to Return product. For questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878. |
| Quantity | 4,920 units |
| Distribution | Worldwide Distribution - US Nationwide, VA/govt/military consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133821 | EMPRINT ABLATION SYSTEM Covidien, LLC, Apr 28, 2014 |