Recall record at a glance
| Official record | Z-0210-2022 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Covidien LLC |
| Report date | Nov 17, 2021 |
| Recall initiation date | Sep 29, 2021 |
| Quantity | 14 units |
| Location | Mansfield, MA, United States |
Official product description
Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Why the product was 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.
Distribution information
No domestic distribution. Foreign distribution to Hong Kong and UK.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: N/A.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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