Recall Z-0210-2022 ยท NEY System, Ablation, Microwave And Accessories
Covidien Llc
Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
| Date | Sep 29, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | Beginning September 29, 2021, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were asked to immediately quarantine and discontinue use of the affected products. Customers should return affected product to the firm. If product has been further distributed, please forward the recall information. Customers should complete and return the accompanying response form even if they do not have product on hand. |
| Quantity | 14 units |
| Distribution | No domestic distribution. Foreign distribution to Hong Kong and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.