Graft, Vascular, Synthetic/biologic Composite
Cardiovascular · 21 CFR 870.3450
Recent MDR events
878 adverse event reports on file
- HEMASHIELD PLATINUM WOVEN STRAIGHTJul 16, 2026MalfunctionIntervascular Sas1640201-2026-0000033
- HEMASHIELD PLATINUM WOVEN STRAIGHTJun 23, 2026InjuryIntervascular Sas2242352-2026-00011
- HEMASHIELD PLATINUM WOVEN STRAIGHTJun 22, 2026InjuryIntervascular Sas1640201-2026-0000032
- HEMASHIELD GOLD KNITTEDMay 25, 2026InjuryIntervascular Sas2242352-2026-00008
- HEMASHIELD GOLD KNITTEDMay 22, 2026InjuryIntervascular Sas1640201-2026-0000030
- HEMASHIELD PLATINUM WOVEN AORTIC ARCH 1BApr 24, 2026MalfunctionIntervascular Sas1640201-2026-0000023
- HEMASHIELD PLATINUM GRAFTApr 21, 2026MalfunctionIntervascular SasMW5187051
- HEMASHIELD PLATINUMMar 19, 2026MalfunctionIntervascular Sas1640201-2026-0000007
- HEMASHIELD PLATINUMFeb 2, 2026InjuryIntervascular Sas2242352-2026-00001
- HEMASHIELD PLATINUMJan 16, 2026InjuryIntervascular Sas1640201-2026-0000002
Event type breakdown
Recalls
49 recall events for this product code
- Vascutek, Ltd.TerminatedJun 26, 2015
Gelseal Straight Diameter 8mm Length 15cm.
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
Z-1912-2015 · View FDA record ↗ - Vascutek, Ltd.TerminatedJun 26, 2015
Gelseal Straight Diameter 8mm Length 30cm.
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
Z-1913-2015 · View FDA record ↗ - LeMaitre Vascular, Inc.TerminatedJul 22, 2013
AlboGraft Knitted with Collagen, Bifurcate 14x08
Blood blushing/leaking from the surface of the graft after implantation
Z-1754-2013 · View FDA record ↗ - LeMaitre Vascular, Inc.TerminatedJul 22, 2013
AlboGraft Knitted with Collagen, Straight 15x06
Blood blushing/leaking from the surface of the graft after implantation
Z-1755-2013 · View FDA record ↗ - LeMaitre Vascular, Inc.TerminatedJul 22, 2013
Albo Graft Knitted with Collagen, Bifurcate 16x08
Blood blushing/leaking from the surface of the graft after implantation
Z-1756-2013 · View FDA record ↗ - LeMaitre Vascular, Inc.TerminatedJul 22, 2013
AlboGraft Knitted with Collagen, Bifurcate 18x09
Blood blushing/leaking from the surface of the graft after implantation
Z-1757-2013 · View FDA record ↗ - LeMaitre Vascular, Inc.TerminatedJul 22, 2013
AlboGraft Knitted with Collagen, Bifurcate 18x10
Blood blushing/leaking from the surface of the graft after implantation
Z-1758-2013 · View FDA record ↗ - LeMaitre Vascular, Inc.TerminatedJul 22, 2013
AlboGraft Knitted with Collagen, Bifurcate
Blood blushing/leaking from the surface of the graft after implantation
Z-1759-2013 · View FDA record ↗ - LeMaitre Vascular, Inc.TerminatedJul 22, 2013
AlboGraft Knitted with Collagen, Straight 40x07
Blood blushing/leaking from the surface of the graft after implantation
Z-1760-2013 · View FDA record ↗ - LeMaitre Vascular, Inc.TerminatedJul 22, 2013
AlboGraft Knitted with Collagen, Straight 40x08
Blood blushing/leaking from the surface of the graft after implantation
Z-1761-2013 · View FDA record ↗
Registered firms
14 firms currently registered for this product code
Isomedix Operations Inc.
S Plainfield, NJ, US
Lemaitre Vascular Inc.
Billerica, MA, US
Intervascular Sas
LA CIOTAT Bouches-du-Rhone, FR
Sterigenics Italy Spa
Minerbio Bologna, IT
Synergy Health Marseille Sas
MARSEILLE CEDEX 14 Provence-Alpes-Cote d'Azur, FR
Vascutek Ltd.
Inchinnan Renfrewshire, GB
Lemaitre Vascular, Inc.
BURLINGTON, MA, US
510(k) clearances
6 clearances for this product code
- Maquet Cardiovascular, LLCSep 10, 2012
K122612 · HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX
- LeMaitre Vascular, Inc.Jan 19, 2011
K103080 · ALBOGRAFT VASCULAR PROSTHESIS
- LeMaitre Vascular, Inc.Jan 14, 2010
K093231 · ALBOGRAFT VASCULAR PROSTHESIS
- Boston Scientific CorpSep 12, 2005
K052302 · HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION
- Boston Scientific CorpApr 19, 2002
K021213 · MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS
- Meadox Medicals, Div. Boston Scientific Corp.Feb 1, 1996
K954848 · HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT