FDA Device recall Z-0210-2022
Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
- FDA Device
- Class II
- terminated
- Published 2021-11-17
On 2021-11-17 the FDA classified a Class II recall of Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1 by Covidien, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0210-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-09-29 |
| Published | 2021-11-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Covidien |
| Distribution | n/a |
Product
Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Reason
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.
Identifiers
| code_info | Lot 516840 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0210-2022%22
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