Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21320 |
| Brand Name: | William Cook Europe Zenith Alpha™ Thoracic Endovascular Graft (ZTA-/-) |
| Model: | |
| Affected: | Proximal Tapered Component; ZTA-PT, Distal Component; ZTA-D, Distal Extension; ZTA-DE, Proximal Component;ZTA-P |
| Software version: | |
| Recalling Organisation: | Obex Medical Ltd Level 3, 109 Carlton Gore Road Newmarket Auckland 1023 |
| Contact Information: | 0800 656 539 |
| Manufacturer: | William Cook Europe ApS |
| Issue: | The manufacturer calls attention to several aspects of the new version of the Instructions for Use (IFU) for the Zenith Alpha Thoracic Endovascular Graft. 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. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 12/4/2017 |
