FDA-Device2021-11-17Class II
Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Covidien Llc
Hazard
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.
Sold states
No domestic distribution. Foreign distribution to Hong Kong and UK.
Affected count
14 units
Manufactured in
15 Hampshire St, N/A, Mansfield, MA, United States
Products
Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0210-2022Don't want to check this manually?
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