Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a Recalled by Vascutek, Ltd. Due to The cautery that is provided with the Gelweave...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Vascutek, Ltd. directly.
Affected Products
Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company
Quantity: 63,162
Why Was This Recalled?
The cautery that is provided with the Gelweave graft in the box has a shorter shelf life indicated on its label, versus that of the graft (4 years and 5 years, respectively).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Vascutek, Ltd.
Vascutek, Ltd. has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report