FDAJuly 8, 2021device
The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
What to do
FDA enforcement status: Terminated
Brands named
vascutek
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAGelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE, 636008PE, 636006PE, 632518PE, 634008PE, 634006PE, 631218PE, 632211PE, 634007PE, 633006PE, 631506PE, 632524...2025-12-18
- FDAThe 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 8m...2021-07-08
- FDAGelseal 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.2015-05-15
- FDAGelseal 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.2015-05-15
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