# FDA recall Z-0210-2022

> **Covidien Llc** · Class II · device recall initiated 2021-09-29.

## 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.

## Distribution

No domestic distribution. Foreign distribution to Hong Kong and UK.

## Key facts

- **Recall number:** Z-0210-2022
- **Recalling firm:** Covidien Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-09-29
- **Report date:** 2021-11-17
- **Termination date:** 2025-02-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mansfield, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0210-2022

## Citation

> AI Analytics. FDA recall Z-0210-2022. Retrieved 2026-07-31 from https://api.ai-analytics.org/recall/Z-0210-2022. Source: US FDA. Licensed CC0.

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