Z-0210-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 17, 2021
- Initiation Date
- September 29, 2021
- Termination Date
- February 13, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 units
Product Description
Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Reason for Recall
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.
Distribution Pattern
No domestic distribution. Foreign distribution to Hong Kong and UK.
Code Information
Lot 516840