Vascutek Recalls
6 recalls on record · August 27, 2014 to March 11, 2026 · Medical Devices
Recalls by year
14
15
21
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 11, 2026Medical DevicesFDA
Vascutek, Ltd. recalls Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 6
Hazard: 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 packaging.
October 6, 2021Medical DevicesFDA
Vascutek, Ltd. recalls The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Pat
Hazard: The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
October 6, 2021Medical DevicesFDA
Vascutek, Ltd. recalls The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Strai
Hazard: The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
July 8, 2015Medical DevicesFDA
Vascutek, Ltd. recalls Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device intended to repair, repla
Hazard: Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
July 8, 2015Medical DevicesFDA
Vascutek, Ltd. recalls Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, repla
Hazard: Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
August 27, 2014Medical DevicesFDA
Vascutek, Ltd. recalls Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company
Hazard: 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).