Intervascular, Inc.

US Last updated 23 May 2026

Devices: 434
Registries: EUDAMEDGUDIDFDA
FDA recalls: 11 ongoing

Catalogue434

Page 1 of 9

Showing 1-50 of 434

FDA recalls1

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

2026
- 12 Aug 2026 Z-3258-2026 Class II Ongoing Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).via FDA establishment Intervascular SAS

FDA establishments1

Registered with the FDA under this company group, matched by name.

Intervascular SAS LA CIOTAT Bouches-du-Rhone · FR FEI 3002707083

Information

Country: US

Catalogue434

Intergard IGKUT0008-40 Ref IGKUT0008-40

Intergard IGK0018-40 Ref IGK0018-40

Hemagard Carotid Patch HGK10/75CP (1) Ref HGK10/75CP (1)

Hemashield M00202175132P0 Ref M00202175132P0

Intergard IGW0028-30 Ref IGW0028-30

Hemagard Carotid Patch HGK12/75CP (1) Ref HGK12/75CP (1)

Hemapatch HEK100/100P (1) Ref HEK100/100P (1)

Hemashield M002020951120 Ref M002020951120

Intergard HEW2210BRIDGE Ref HEW2210BRIDGE

POLYESTER TAPE Size 6.4mm x 76.2cm (1/4 in x 30 in) Ref Size 6.4mm x 76.2cm (1/4 in x 30 in)

Hemagard HGK0006-20 Ref HGK0006-20

Hemagard HGKUT0007-40 Ref HGKUT0007-40

Hemagard HGK0024-40 Ref HGK0024-40

Intergard IGKUT0006RS30 Ref IGKUT0006RS30

Hemashield M002000195140 Ref M002000195140

Hemashield M002020951070 Ref M002020951070

Hemashield M002020851890 Ref M002020851890

Hemashield M002020851800 Ref M002020851800

Hemashield M00202019575P0 Ref M00202019575P0

Intergard IGK0008-20 Ref IGK0008-20

Intergard IGK2412 Ref IGK2412

Hemashield M002000195290 Ref M002000195290

Hemagard HGKAX0808 Ref HGKAX0808

Intergard IGKUT0006-20 Ref IGKUT0006-20

Intergard IGK1206 Ref IGK1206

Intergard IGK0008RS15 Ref IGK0008RS15

Hemashield M002000196240 Ref M002000196240

Hemagard HGKUT0006RS20 Ref HGKUT0006RS20

Hemashield M002000196270 Ref M002000196270

Hemagard HGK0007-40 Ref HGK0007-40

Hemashield M00202019530P0 Ref M00202019530P0

Intergard IGW0010-30 Ref IGW0010-30

Hemashield M00202175418P0 Ref M00202175418P0

Intergard IGW0024-60 Ref IGW0024-60

Hemagard HGKUT0006-20 Ref HGKUT0006-20

Intergard HEW2010BRIDGE Ref HEW2010BRIDGE

Hemashield M00202175307P0 Ref M00202175307P0

Intergard IGKAX1010 Ref IGKAX1010

Hemashield M00202175126P0 Ref M00202175126P0

Intergard IGK0007-20 Ref IGK0007-20

Hemagard Patch HGK20/140P (1) Ref HGK20/140P (1)

Hemagard Patch HGK10/140P (1) Ref HGK10/140P (1)

Hemashield M002020852410 Ref M002020852410

Intergard HEWAA3410080810/1 Ref HEWAA3410080810/1

Hemashield M00202019579P0 Ref M00202019579P0

Hemagard HGK0007-20 Ref HGK0007-20

Hemashield M002020952180 Ref M002020952180

Hemashield M002020952120 Ref M002020952120

Intergard IGW0038-30 Ref IGW0038-30

Hemashield M002020953060 Ref M002020953060

FDA recalls1

FDA establishments1

Information