| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01018-1 |
| Product Name/Description |
Covidien Emprint Percutaneous Antennas with Thermosphere Technology
Emprint Percutaneous Antenna with Thermosphere Technology, Short (15cm)
Item Code: CA15L1
Emprint Percutaneous Antenna with Thermosphere Technology, Standard (20cm)
Item Code: CA20L1
Emprint Percutaneous Antenna with Thermosphere Technology, Long (30cm)
Item Code: CA30L1
Lot Numbers beginning with S5L through S7G
Expiration: November 2017 through July 2019
ARTG Number: 178369 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
10/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic have received reports that the ceramic trocar tip of the Emprint ablation antenna is disengaging from the needle shaft post-ablation. Tip disengagement can result in the ceramic trocar tip remaining in the patient presenting a risk of latent migration and potential damage to adjacent tissue. Four of the complaint reports indicate that the trocar tip was not retrieved. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic is requesting customers:
1.Quarantine and discontinue use of the specified item codes and lots;
2.Immediately advise all surgeons/surgery personnel of this recall;
3. Check if their facility has distributed the affected products to other persons or facilities, if so, please promptly forward a copy of this letter to those recipients;
4. Email the completed Recall Response Form supplied with the customer letter to Medtronic's Regulatory Affairs Department at ANZ.Recalls@covidien.com or fax to 02 8904 8798. Please include a copy of the Recall Response Form with the returned units; and
5. Label the goods with the provided (ZRE#) for easy identification. Do not return goods without the corresponding ZRE# provided by Medtronic.
This action has been closed out on 14/02/2019 |
| Contact Information |
02 9429 3179 - Medtronic |