Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation Recalled by Covidien Llc Due to The firm identified an error in the device...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Covidien Llc directly.
Affected Products
Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Quantity: 14 units
Why Was This Recalled?
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.
Where Was This Sold?
No domestic distribution. Foreign distribution to Hong Kong and UK.
About Covidien Llc
Covidien Llc has 59 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report