Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is Recalled by Vascutek, Ltd. Due to Product was labeled as a 30cm graft, when...

Date: May 15, 2015
Company: Vascutek, Ltd.
Status: Terminated
Source: FDA (Device)

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

Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.

Quantity: 12

Why Was This Recalled?

Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.

Where Was This Sold?

Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.

About Vascutek, Ltd.

Vascutek, Ltd. has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report