Covidien Emprint Ablation Catheter with Thermosphere Technology… — Class II medical device recall Z-0210-2022
Terminated recall by Covidien Llc, reported 2021-11-17. The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt ene
| Recall number | Z-0210-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien Llc, Mansfield, MA, United States |
| Recall initiated | 2021-09-29 |
| Classified | 2021-11-05 |
| Reported by FDA | 2021-11-17 |
| Terminated | 2025-02-13 |
| Countries outside the US | GB, HK |
| Quantity | 14 units |
| Reason classes | device malfunction |
| Lot numbers | 516840 |
Product
Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Reason for recall
The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling system failure. Use of an affected device in conjunction with a primary cooling system failure could lead to the applicator tip overheating and associated heat damage which could result in an allergic/toxic reaction, unintended tissue ablation, tissue burn, and/or a delay of treatment while an alternate device is located.
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-0210-2022. 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.