Short Percutaneous Antenna with Thermosphere" Technology Standard… — Class II medical device recall Z-1187-2016
Terminated recall by Covidien Medical Products (Shanghai) Manufacturing L.L.C., reported 2016-03-23, distributed nationwide. Medtronic is voluntarily recalling specific item codes and production lots of Covidien Emprint" Percutaneous A
| Recall number | Z-1187-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien Medical Products (Shanghai) Manufacturing L.L.C., Shanghaishi, China |
| Recall initiated | 2016-02-23 |
| Classified | 2016-03-17 |
| Reported by FDA | 2016-03-23 |
| Terminated | 2017-06-21 |
| Distributed | Nationwide (US) |
| Quantity | 4,920 units |
| Model numbers | CA15L1, CA20L1, CA30L1 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1187-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.