Vascutek, Ltd. Newmains Avenue Inchinnan United Kingdom 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 Ge Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 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 Ge
Brand
Vascutek, Ltd. Newmains Avenue Inchinnan United Kingdom
Lot Codes / Batch Numbers
To be reported.
Products Sold
To be reported.
Vascutek, Ltd. Newmains Avenue Inchinnan United Kingdom is recalling The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax due to The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
Recommended Action
Per FDA guidance
The recalling firm sent emails on 7/8/2021 to the two distributors that contained the Field Safety Notice and the correct IFU to be supplied with products distributed to the United States.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026