Covidien Emprint Ablation Catheter with Thermosphere recall
Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Why was Covidien Emprint Ablation Catheter with Thermosphere 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 516840
- Product
- Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
- Recalling firm
- Covidien Llc
- Quantity
- 14 units
- Distribution
- No domestic distribution. Foreign distribution to Hong Kong and UK.
- Recall date
- November 17, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)