Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18087 |
| Brand Name: | Cook Zenith Alpha™ Thoracic Endovascular Graft |
| Model: | All models |
| Affected: | All lots |
| 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 instructions for use supplied with the device are being updated in response to 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. To date, no similar events have been reported from markets in which the device is commercially available. These findings from the clinical investigation were found to be associated with thoracic aneurysms (not ulcers) treated with a single proximal component that resulted in a short distal seal length (i.e., less than 20 mm) and likely inadequate (i.e., less than 10%) distal oversizing for the device. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 12/2/2015 |
