Z-1187-2016 Class II Terminated
FDA device recall Z-1187-2016 was initiated by Covidien Medical Products (Shanghai) Manufacturing L.L.C. on February 23, 2016 and is designated Class II. 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 i… The recall status is terminated (terminated June 21, 2017). Affected quantity: 4,920 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 23, 2016
- Initiation Date
- February 23, 2016
- Termination Date
- June 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,920 units
Product Description
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, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors. The CovidienEmprint Ablation System is not intended for use in cardiac procedures
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.
Distribution Pattern
Worldwide Distribution - US Nationwide, VA/govt/military consignees.
Code Information
Model Numbers: CA15L1, CA20L1 and CA30L1