Recall Z-0210-2022— Covidien Llc
Class II · Terminated
Class II FDA medical device recall by Covidien Llc, initiated 2021-09-29, terminated 2025-02-13. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Covidien Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-09-29
- Terminated
- 2025-02-13
- Firm location
- Mansfield, MA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.