Vascutek Vascular Grafts Recalled for Incorrect Instructions for Use
Vascutek is recalling vascular grafts distributed to Puerto Rico and Guam that contained wrong Instructions for Use prepared for international rather than U.S. consignees. Improper instructions pose a risk of incorrect device use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device recall with no reported injuries or illnesses. The hazard is instructional mismatch (incorrect regional Instructions for Use) without documented harm, qualifying as a risk-of-harm product where injury has not been reported, per severity rubric score 3 criteria.
Plain-English summary
Vascutek, Ltd. is recalling certain vascular graft devices and their accompanying Instructions for Use. The recalled devices include Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, Gelsoft Plus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Valsalva in multiple sizes, totaling approximately 159 units.
The Instructions for Use provided with these devices were prepared for rest-of-world international consignees rather than U.S. consignees. This creates a mismatch between the provided instructions and U.S. healthcare requirements and practices.
The affected devices were distributed to healthcare facilities in Puerto Rico and Guam. Affected healthcare providers should contact Vascutek, Ltd. for corrected Instructions for Use designed for U.S. use. Patients with these devices should contact their healthcare provider with questions.
The recalled product
- Product
- The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Valsalva vascular grafts: (1) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthe
- Manufacturer
- Vascutek, Ltd.
- Category
- Medical Device — Vascular Graft
- Hazard
- instruction-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- To be reported.
Distribution
Distributed in 1 state:
- PR
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