medical Class II Updated 2021-11-17

Covidien Llc recalls Covidien Emprint Ablation Catheter with Thermosphere Technol

Recalled Product

Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1


Hazard / Issue

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.

Issued by

FDA

Distribution: No domestic distribution. Foreign distribution to Hong Kong and UK.
Lot/Code Info: Lot 516840
View official government recall

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