Class II — Covidien Llc
| Recalling firm | Covidien llc |
|---|---|
| Registered facility | View this company's 22 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1 |
| Quantity | 14 units |
| Distribution | No domestic distribution. Foreign distribution to Hong Kong and UK. |
| Initiated | 2021-09-29 |
| Classified | 2021-11-05 |
| Terminated | 2025-02-13 |
| Recall number | Z-0210-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Covidien Llc (Z-0210-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88817/
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