Covidien Emprint Ablation Catheter temperature monitoring defect
Covidien is recalling the Emprint Ablation Catheter due to a defect in temperature monitoring circuitry. If the cooling system fails during use, the device tip could overheat, causing tissue burns, unintended ablation, and allergic reactions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with potential for serious patient harm including tissue burns and unintended ablation. No injuries have been reported; the hazard is conditional and requires both device malfunction and continued use to manifest.
Plain-English summary
Covidien LLC is recalling the Emprint Ablation Catheter with Thermosphere Technology (model CFN CA108L1) due to an error in the device's temperature monitoring circuitry.
The temperature monitoring system is designed to halt energy delivery if the primary cooling system fails. Due to the circuit error, if a primary cooling system failure occurs during device use, the applicator tip could overheat. Overheating could result in tissue burns, unintended tissue ablation, allergic or toxic reactions, and delays in treatment while an alternative device is located.
The recall involves 14 units distributed to Hong Kong and the United Kingdom. No units were distributed in the United States. Affected units are identified by lot number 516840.
The recalled product
- Product
- Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
- Manufacturer
- Covidien Llc
- Affected units
- 14
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 516840
Distribution
Distribution scope not specified by the agency.
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