Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 22345 |
| Brand Name: | Vascutek Gelsoft Plus |
| Model: | |
| 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: | Vascutek Ltd |
| Brand Name: | Vascutek Gelweave Grafts |
| Model: | |
| 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: | Vascutek Ltd |
| Brand Name: | Vascutek Cardiovascular Patch |
| Model: | |
| 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: | Vascutek Ltd |
| Brand Name: | Vascutek Graft Sizer |
| Model: | |
| 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: | Vascutek Ltd |
| Brand Name: | Vascutek Unsealed PTFE (Maxiflo) |
| Model: | |
| 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: | Vascutek Ltd |
| Brand Name: | Vascutek Seal PTFE |
| Model: | |
| 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: | Vascutek Ltd |
| Brand Name: | Vascutek Thoraflex Hybrid Device |
| Model: | |
| 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: | Vascutek Ltd |
| Issue: | The manufacturer has reviewed the IFU contents to ensure consistency across all product families and to ensure that the Instructions for Use provide state of the art instruction and content to users. As a result of these updates, further clarity will be provided to Clinicians regarding immersion of grafts in saline solution, and to enhance knowledge on the use of formaldehyde in the manufacturing process. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 8/12/2017 |
