Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 17011 |
| 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 RVOT Elan Biplex Conduit |
| 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: | Manufacturer provides a high temperature cautery with each Gelweave and Thoraflex Hybrid product and a low temperature cautery with each BioValsalva Stentless Biplex , Stented BioValsalva Biplex and RVOT elan Biplex conduit. These cauteries are used to cut and trim the graft. Manufacturer has decided to stop supplying the cautery with these product packs due to the cautery battery having a shorter shelf life than the Vascutek graft product. Manufacturer will update the IFU, removing the reference to the inclusion of a catery with thes products. Manufacturer will not be recalling any product as there is negligible rsk to users and patients. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 16/7/2014 |
