Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Thermosphere" Technology; Th
FDA device recall Z-1187-2016 · posted 2016-03-17 · Terminated
Recall details
- Recalling firm
- Covidien Medical Products (Shanghai) Manufacturing L.L.C.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NEY
- Quantity affected
- 4,920 units
- Distribution
- Worldwide Distribution - US Nationwide, VA/govt/military consignees.
- Date initiated
- 2016-02-23
- Date posted
- 2016-03-17
- Date terminated
- 2017-06-21
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EMPRINT ABLATION SYSTEM (K133821) | Covidien, LLC | 2014-04-28 |