Vascutek Thoraflex Hybrid Device
- Recalling firm
- Obex Medical Ltd
- Product
- Vascutek Thoraflex Hybrid Device. [Device]. Model: THORAFLEX ANTEFLO; THORAFLEX PLEXUS. Affected: Multiple Product Codes; Multiple Product Codes. Also covers: Vascutek Gelweave Grafts
- Reason
- 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...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-03-18
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/37bc05ab-fc44-4925-abe1-bac1fd940e4a