Vascutek

5 recalls •

🏥 Medical Devices

• Categories: Other Medical Devices, Implants & Prosthetics

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 Prosthesis, Bifurcate, 14 x 8mm, Bifurcate 45cm, REF 631408, sterile. (2) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 16 x 8mm, Bifurcate 45cm, REF 631608, sterile. (3) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 18 x 9mm, Bifurcate 45 cm, REF 631809, sterile. (4) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 20 x 10mm, Bifurcate 45cm, REF 632010, sterile. (5) Vascutex Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 22 x 11mm, Bifurcate 45cm, REF 632211, sterile

Class I - Dangerous

The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.

Jul 8, 2021 Other Medical Devices View Details →

The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t

Class I - Dangerous

The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.

Jul 8, 2021 Other Medical Devices View Details →

Gelseal Straight Diameter 8mm Length 15cm. 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.

Class I - Dangerous

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

May 15, 2015 Implants & Prosthetics View Details →

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.

Class I - Dangerous

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

May 15, 2015 Implants & Prosthetics View Details →

Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company

Class I - Dangerous

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).

Jul 15, 2014 Other Medical Devices Nationwide View Details →