Covidien recalls Emprint Ablation Catheter with Thermosphere Technology (CFN CA108L1) due to temperature monitoring error that could cause overheating and tissue damage if primary cooling fails.
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.
Covidien is recalling its Emprint Ablation Catheter with Thermosphere Technology (model CFN CA108L1) because a temperature monitoring error could cause the device to overheat if the primary cooling system fails. This risk may lead to tissue burns, allergic reactions, or delayed treatment.
The device's temperature monitoring circuitry has an error that may not interrupt energy delivery during primary cooling system failure. This could cause the catheter tip to overheat, potentially damaging tissue and causing allergic reactions, burns, or treatment delays.
Healthcare professionals using the Emprint Ablation Catheter for bronchoscopic procedures are most at risk. Patients undergoing these procedures with the affected device could experience complications.
Check for the model number CFN CA108L1 on the device. The recall applies to the specific lot number 516840.
Look for the model number CFN CA108L1 on the device label.
Reach out to Covidien LLC for guidance on next steps if you have the recalled device.
The recall indicates the device has a temperature monitoring error that could cause overheating if the primary cooling system fails, so it is not safe to use without proper monitoring.
Check the model number on the device; if it's CFN CA108L1, contact Covidien LLC for guidance.
No, the device has a known error that could cause tissue damage if the primary cooling system fails, so it should not be used without manufacturer guidance.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-0210-2022 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0210-2022 from Covidien. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
