Vascutek, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
26
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1492-2026Class IIGelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 6December 18, 2025
Z-2542-2021Class IIThe Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS AxJuly 8, 2021
Z-2543-2021Class IIThe Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN saysJuly 8, 2021
Z-1912-2015Class IIGelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intenMay 15, 2015
Z-1913-2015Class IIGelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device intenMay 15, 2015
Z-2266-2014Class IIGelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO companyJuly 15, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K241550Gelweave™ Vascular ProsthesesFebruary 27, 2025
K241070Gelsoft™ Plus Vascular ProsthesesNovember 15, 2024
K202703Vascutek Gelsoft Plus ERS Vascular GraftApril 6, 2021
K200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchJuly 8, 2020
K162803Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular GraftsJuly 14, 2017
K162794Gelweave Vascular GraftsJune 30, 2017
K093817GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERSJanuary 7, 2010
K092863MAXIFLO, TAPERFLOOctober 8, 2009
K091778VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTSAugust 31, 2009
K090987VASCUTEK BRANCHED GELWEAVEJune 19, 2009
K081560VASCUTEK CANNULA GRAFT, MODEL CGS2008SFebruary 10, 2009
K070323TEMPORARY LIMB SALVAGE SHUNTFebruary 15, 2007
K060142VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERSFebruary 7, 2006
K043552VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESESJanuary 5, 2005
K041528MODIFICATION TO EPTFE GRAFTSeptember 14, 2004
K040829GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLARMay 20, 2004
K034010GELSOFT PLUS ERSFebruary 19, 2004
K030999EPTFE VASCULAR PROSTHESIS; SEALPTFEApril 9, 2003
K964959VASCUTEK TWILLWEAVE VASCULAR GRAFTMarch 10, 1997
K963611VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CARNovember 21, 1996