Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36669 |
| Brand Name: | Vascutek Thoraflex Hybrid Device |
| Model: | THORAFLEX ANTEFLO |
| Affected: | Multiple Product Codes |
| 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: | THORAFLEX PLEXUS |
| Affected: | Multiple Product Codes |
| 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 updated the IFU for Thoraflex Hybrid products to improve guidance for end-users. Section 4.5 – Treatment and Follow-up: Patients with potential risk factors for postoperative intraluminal thrombosis after FET should be considered for earlier imaging surveillance and treatment, as outlined in Section 14.7. Section 14.7 – Additional Surveillance and Treatment: Early additional monitoring is recommended for patients with suspected risk factors for intraluminal thrombosis. If thrombosis is detected, clinicians should follow current clinical practice guidelines when developing an individualized treatment plan. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 18/3/2026 |
