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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Vascutek, Ltd.
- Category
- Medical Device — Vascular Graft
- Hazard
- Affected units
- 159
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
Part of a larger recall action
This product is one of 2 recalled by Vascutek, Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Vascutek, Ltd.
See all →- ModerateVascular grafts recalled after expiry dates were calculated from packaging
FDA (Devices) · 2026-03-11
- HighCarotid and Gelsoft vascular patches recalled for incorrect instructions
FDA (Devices) · 2021-10-06
- ModerateVascutek Gelseal Vascular Grafts Recalled for Incorrect Length Labeling
FDA (Devices) · 2015-07-08
- ModerateVascutek Gelseal Vascular Grafts Recalled for Incorrect Length Labeling
FDA (Devices) · 2015-07-08
- ModerateVascutek Recalls Gelweave Vascular Prostheses Due to Cautery Shelf Life Labeling
FDA (Devices) · 2014-08-27
Same hazard · instruction error
See all →- ModerateDEX Ophthalmic Tissue Forceps instructions for use correction
FDA (Devices) · 2026-05-13
- ModerateMedical device recall: sterilization validator with incorrect incubation time
FDA (Devices) · 2025-03-05
- HighMedical Device Thawing Kit Recalls Due to Spanish Instruction Translation Error
FDA (Devices) · 2022-07-27
- ModerateDocumentation errors recalled in HeartWare HVAD instructions and manuals
FDA (Devices) · 2022-05-25
- LowKi Mobility Little Wave Tyke Manual Contains Incorrect Instructions
FDA (Devices) · 2022-01-19
Similar recalls
- ModerateTerumo Recalls Mislabelled Vascutek Gelsoft Vascular Grafts
FDA (Devices) · 2013-11-27
- ModerateVascular grafts recalled after expiry dates were calculated from packaging
FDA (Devices) · 2026-03-11
- ModerateVascutek Gelseal Vascular Grafts Recalled for Incorrect Length Labeling
FDA (Devices) · 2015-07-08
- ModerateVascutek Recalls Gelweave Vascular Prostheses Due to Cautery Shelf Life Labeling
FDA (Devices) · 2014-08-27
- ModerateBaxter surgical tool marketing brochures contain inaccurate Instructions for Use
FDA (Devices) · 2024-04-24
- HighVascu-Guard Peripheral Vascular Patch marketing materials contain inaccurate information
FDA (Devices) · 2024-01-17