Type of Product |
Medical Device |
TGA Recall Reference |
RC-2017-RN-00419-1 |
Product Name/Description |
Multiple Zenith Alpha Thoracic Endovascular Graft Products
All products that start with the following Catalogue Numbers:
Proximal Tapered Component; ZTA-PT- Distal Component; ZTA-D- Distal Extension; ZTA-DE- Proximal Component; ZTA-P-
ARTG Numbers: 222505, 222526, 222533, 222525 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
29/03/2017 |
Responsible Entity |
|
Reason/Issue |
The Instructions for Use (IFU) for the Zenith Alpha Thoracic Endovascular Graft have been updated. These updates are of key importance when using the device to treat blunt thoracic aortic injury (BTAI), which is now covered under the newly approved indication for isolated lesions of the descending thoracic aorta. There have been five reports of graft thrombosis/occlusion during global commercial use of the device, each following treatment for BTAI. One case resulted in patient death, and three cases resulted in reintervention.
Patients already treated for BTAI should be followed in accordance with the current IFU, since follow-up has not been amended. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
Cook Medical is requesting surgeons refer to the new version of the Instructions for Use (IFU) for the Zenith Alpha Thoracic Endovascular Graft in particular to the key updates regarding the use of the device to treat blunt thoracic aortic injury (BTAI), which is now covered under the newly approved indication for isolated lesions of the descending thoracic aorta. Surgeons are advised that patients already treated for BTAI should be followed in accordance with the current IFU, since follow-up has not been amended. (Please note that this recall is for information purposes. No devices need to be returned).
This action has been superseded by RC-2017-RN-00824-1 |
Contact Information |
1800 777 222 - Cook Medical Customer Service |