Medical device manufacturer, Medtronic, issued a medical device safety alert concerning its Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation [Item Code: CA108L1; Affected Lot Number: 516840].
The manufacturer is conducting a voluntary recall due to an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling system failure. According to the manufacturer, 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.
The manufacturer is instructing affected users to take the following actions:
According to the local supplier, the affected devices are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 29 Sep 2021