| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00210-1 |
| Product Name/Description |
Covidien Emprint Percutaneous Antenna (short, standard & long) with Thermosphere Technology (used with microwave generator for coagulation of soft tissue)
Item Codes: CA15L1, CA20L1, CA30L1
Multiple Lot Numbers
ARTG Number: 178369 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
26/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
This recall is being conducted following customer reports of the Emprint ablation generator shutting down due high temperature measurements in the Emprint Percutaneous Antenna.
If the generator shuts down due to elevated temperature readings at the antenna tip, the antenna must be replaced and the ability to tract ablate is limited. Antenna replacement can result in a delay in treatment or the inability to treat and increases the risk of bleeding and, in the case of lung procedures, the occurrence of pneumothorax.
There have been no reports of serious injury associated with this recall. |
| Recall Action |
Recall |
| Recall Action Instructions |
Covidien is advising users to quarantine and discontinue use of the affected units. Covidien will arrange for the recovery of these units and the issuance of credit to the affected customers.
This action has been closed out on 29/10/2018 |
| Contact Information |
02 9429 3179 - Covidien |