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Sources: EU EUDAMED, US FDA
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Artegraft¿ Collagen Vascular Graft; REF: AG1015;
FDA Enforcement
Class II
·Ongoing·LeMaitre Vascular, Inc.·October 29, 2025
Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a substitute conduit for blood where bypass or replacement of occluded or diseased arterial segments is required or to establish a conduit for hemodialysis.
FDA Enforcement
Class II
·Ongoing·LeMaitre Vascular, Inc.·October 15, 2025
Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;
FDA Enforcement
Class II
·Ongoing·LeMaitre Vascular, Inc.·October 8, 2025
Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
FDA Enforcement
Class II
·Ongoing·LeMaitre Vascular, Inc.·May 21, 2025
TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-64, E1651-68, E1651-78, E1651-84, E1651-88, 1651-44J, 1651-48J, 1651-84J, 1651-88J.
FDA Enforcement
Class II
·Ongoing·LeMaitre Vascular, Inc.·May 21, 2025
Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
FDA Enforcement
Class II
·Ongoing·LeMaitre Vascular, Inc.·May 21, 2025
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
FDA Enforcement
Class II
·Ongoing·LeMaitre Vascular, Inc.·May 22, 2024
LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the removal of an incompetent greater saphenous vein. Catalog Number: 7210023, lot #61049252
FDA Enforcement
Class III
·Terminated·LeMaitre Vascular, Inc.·March 25, 2015
Albo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Woven with Collagen, Straight 15x26 Catalog Number: ATC1526 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Knitted with Collagen, Bifurcate 18x09 Catalog Number: AMC1809 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Woven with Collagen, Straight 30x16 Catalog Number: ATC3016 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Woven with Collagen, Straight 30x26 Catalog Number: ATC3026 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·April 10, 2013