Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 29119 |
| Brand Name: | Vascutek Gelsoft Plus |
| Model: | |
| Affected: | implemented IFU updates for their gelatin sealed vascular prostheses as a result of a change to gelatin supplier |
| 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: | implemented IFU updates for their gelatin sealed vascular prostheses as a result of a change to gelatin supplier |
| 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: | implemented IFU updates for their gelatin sealed vascular prostheses as a result of a change to gelatin supplier |
| 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: | implemented IFU updates for their gelatin sealed vascular prostheses as a result of a change to gelatin supplier |
| 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: | implemented IFU updates for their gelatin sealed vascular prostheses as a result of a change to gelatin supplier |
| 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: | implemented IFU updates for their gelatin sealed vascular prostheses as a result of a change to gelatin supplier |
| 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 implemented IFU updates for their gelatin sealed vascular prostheses as a result of a change to gelatin supplier. There is no change to the manufacturing process, device, or design of any of the product ranges listed above. These changes do not impact the intended use or indications for use. There have been new contraindications and new warnings/precautions added; however, the quality, safety, performance, efficacy or fitness for purpose of the devices are not affected. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 15/3/2022 |
