Vascutek, Ltd.: Medical Device Recall in 2021 - (Recall #: Z-2542-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 8, 2021

Date Posted: October 6, 2021

Recall Number: Z-2542-2021

Event ID: 88278

Reason for Recall:

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

Status: Terminated

Product Quantity: 159 total vascular grafts and patches

Code Information:

To be reported.

Distribution Pattern:

Distribution was made to PR and Guam.

Voluntary or Mandated:

Voluntary: Firm initiated