| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00101-1 |
| Product Name/Description |
Zenith Alpha Thoracic Endovascular Graft
ARTG numbers: 222505, 222525, 222526 & 222533. |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
10/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Cook Medical is informing their customers that additional warnings and precautions are being implemented in the Instructions for Use (IFU) for the Zenith Alpha Thoracic Endovascular Graft. The updates to the IFU are being made to emphasise best practices in response to a few recent findings of distal Type I endoleak, migration and aneurysm growth during on-going longer-term follow-up of patients enrolled in the multi-national clinical investigation of the device. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Cook Medical is notifying surgeons and hospitals of the updated information in the package insert. Surgeons are advised that patients already implanted with the device should receive additional surveillance and treatment where required.
Further information can be found on the TGA web site at https://www.tga.gov.au/alert/zenith-alpha-thoracic-endovascular-graft. This action has been closed-out on 15/02/2017. |
| Contact Information |
07 3434 6000 - William A. Cook Australia Pty Ltd |