Covidien Llc Recall 88817
Description: Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Covidien Llc Recall 88817 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0210-2022 |
| Event ID | 88817 |
| Event Description | Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1 |
| Product Type | Devices |
| Distribution | No domestic distribution. Foreign distribution to Hong Kong and UK. |
| Quantity | 14 units |
| Recall Reason | 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. |
| Device Classification | 20211117 |
| Device Code Info | Lot 516840 |
| Center Classification Date | 20211105 |
| Recall Initiation Date | 20210929 |
| Recalling Firm | Covidien Llc |
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