Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26615 |
| Brand Name: | Gore TAG Thoracic Endoprosthesis (including Conformable) |
| Model: | |
| Affected: | All lot numbers |
| Software version: | |
| Recalling Organisation: | InterMed Medical Ltd 71 Apollo Drive Albany AUCKLAND 1311 |
| Contact Information: | 0800 333 444 |
| Manufacturer: | W L Gore & Associates Inc |
| Issue: | The manufacturer has received reports for two separate events for GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System. The first was where the device remained at intermediate diameter after successful primary deployment. The secondary deployment line when removed did not actuate deployment of the device to full diameter and was not accessible via the Deployment Line Access Hatch. The second report where difficulty withdrawing the delivery catheter was encountered due to a proximal stent apex being lodged within the delivery catheter leading olive. Based on these events, the manufacturer will be updating its Instructions for Use (IFU) to include a new Warning |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 24/9/2020 |
