Facility

VASCUTEK LTD.

4 recall(s) on record — most severe on record: Class II.

Key facts

4recalls · worst Class II

1inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3002808437
Establishment type	Manufacture Medical Device
Location	Newmains Avenue Inchinnan Renfrewshire, GB PA4 9RR
Registration status	Active · expires 2026
Parent company	VASCUTEK LTD. (owner-operator 10039218)
Brand names	Gelweave branched vascular grafts with radiopaque markers

Activity by year

Recalls (4)
Inspections (1)

Devices registered here (1)

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Product code DSY (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.3450

Recalls & enforcement

Class IIOngoing2025-12-18
Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device pa…
Class IITerminated2021-07-08
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
Class IITerminated2015-05-15
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
Class IITerminated2014-07-15
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).

FDA inspections (1)

VAI2022-11-17
Voluntary Action Indicated · Project Evaluation: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by VASCUTEK LTD.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “VASCUTEK LTD. (FEI 3002808437) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002808437-vascutek-ltd/

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