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LeMaitre Vascular, Inc.

58 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Artegraft Vascular Graft; REF#: AG740; recall (Z-1574-2026)LeMaitre Vascular, Inc.2026-03-19
Artegraft Collagen Vascular Graft; REF: AG1015; recall (Z-0289-2026)LeMaitre Vascular, Inc.2025-10-23
Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG7 recall (Z-0072-2026)LeMaitre Vascular, Inc.2025-10-08
Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) recall (Z-0034-2026)LeMaitre Vascular, Inc.2025-10-02
TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, recall (Z-1750-2025)LeMaitre Vascular, Inc.2025-05-12
Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, recall (Z-1751-2025)LeMaitre Vascular, Inc.2025-05-12
Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09. recall (Z-1752-2025)LeMaitre Vascular, Inc.2025-05-12
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and perip recall (Z-1824-2024)LeMaitre Vascular, Inc.2024-05-15
The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be recall (Z-2468-2023)LeMaitre Vascular, Inc.2023-08-28
TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lume recall (Z-0228-2023)LeMaitre Vascular, Inc.2022-11-11
LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88 recall (Z-1567-2020)LeMaitre Vascular, Inc.2020-04-01
LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicate recall (Z-0378-2016)LeMaitre Vascular, Inc.2015-12-04
LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the rem recall (Z-0379-2016)LeMaitre Vascular, Inc.2015-12-04
LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicate recall (Z-0380-2016)LeMaitre Vascular, Inc.2015-12-04
LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88. Ind recall (Z-0381-2016)LeMaitre Vascular, Inc.2015-12-04
LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicate recall (Z-0382-2016)LeMaitre Vascular, Inc.2015-12-04
LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. Indicated for recall (Z-0383-2016)LeMaitre Vascular, Inc.2015-12-04
LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the recall (Z-0384-2016)LeMaitre Vascular, Inc.2015-12-04
LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for the recall (Z-0385-2016)LeMaitre Vascular, Inc.2015-12-04
LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicate recall (Z-0386-2016)LeMaitre Vascular, Inc.2015-12-04
LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. Indicate recall (Z-0387-2016)LeMaitre Vascular, Inc.2015-12-04
LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicate recall (Z-0388-2016)LeMaitre Vascular, Inc.2015-12-04
LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indi recall (Z-0389-2016)LeMaitre Vascular, Inc.2015-12-04
LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Ind recall (Z-0390-2016)LeMaitre Vascular, Inc.2015-12-04
LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to recall (Z-1294-2015)LeMaitre Vascular, Inc.2015-03-18
AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 AlboGraft Vascula recall (Z-1754-2013)LeMaitre Vascular, Inc.2013-07-22
AlboGraft Knitted with Collagen, Straight 15x06 Catalog Number: AMC1506 AlboGraft Vascular recall (Z-1755-2013)LeMaitre Vascular, Inc.2013-07-22
Albo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 AlboGraft Vascul recall (Z-1756-2013)LeMaitre Vascular, Inc.2013-07-22
AlboGraft Knitted with Collagen, Bifurcate 18x09 Catalog Number: AMC1809 AlboGraft Vascula recall (Z-1757-2013)LeMaitre Vascular, Inc.2013-07-22
AlboGraft Knitted with Collagen, Bifurcate 18x10 Catalog Number: AMC1810 AlboGraft Vascula recall (Z-1758-2013)LeMaitre Vascular, Inc.2013-07-22
AlboGraft Knitted with Collagen, Bifurcate 20x10Catalog Number: AMC2010 AlboGraft Vascular recall (Z-1759-2013)LeMaitre Vascular, Inc.2013-07-22
AlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 AlboGraft Vascular recall (Z-1760-2013)LeMaitre Vascular, Inc.2013-07-22
AlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 AlboGraft Vascular recall (Z-1761-2013)LeMaitre Vascular, Inc.2013-07-22
AlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 AlboGraft Vascular recall (Z-1762-2013)LeMaitre Vascular, Inc.2013-07-22
AlboGraft Knitted with Collagen, Straight 60x07 Catalog Number: AMC6007 AlboGraft Vascular recall (Z-1763-2013)LeMaitre Vascular, Inc.2013-07-22
AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 AlboGraft Vascular recall (Z-1764-2013)LeMaitre Vascular, Inc.2013-07-22
AlboGraft Woven with Collagen, Straight 15x26 Catalog Number: ATC1526 AlboGraft Vascular G recall (Z-1765-2013)LeMaitre Vascular, Inc.2013-07-22
AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboGraft Vascular G recall (Z-1766-2013)LeMaitre Vascular, Inc.2013-07-22
AlboGraft Woven with Collagen, Straight 30x16 Catalog Number: ATC3016 AlboGraft Vascular G recall (Z-1767-2013)LeMaitre Vascular, Inc.2013-07-22
AlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 AlboGraft Vascular G recall (Z-1768-2013)LeMaitre Vascular, Inc.2013-07-22
AlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 AlboGraft Vascular G recall (Z-1769-2013)LeMaitre Vascular, Inc.2013-07-22
AlboGraft Woven with Collagen, Straight 30x26 Catalog Number: ATC3026 AlboGraft Vascular G recall (Z-1770-2013)LeMaitre Vascular, Inc.2013-07-22
LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Inte recall (Z-1054-2013)LeMaitre Vascular, Inc.2013-04-04
Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips). I recall (Z-1055-2013)LeMaitre Vascular, Inc.2013-04-04
LeMaitre 9F Pruitt F3 Outlying Carotid Shunt with T-port The Pruitt F3 Carotid Shunt (the recall (Z-0070-2012)Lemaitre Vascular, Inc.2011-10-19
LeMaitre VascuTape Radiopaque Tape, LeMaitre Stent Guide, 20 strips Catalog Number: 1102-2 recall (Z-0433-2011)Lemaitre Vascular, Inc.2010-11-22
LeMaitre VascuTape Radiopaque Tape, LeMaitre Stent Guide, 100 strips Catalog Number: 1102- recall (Z-0434-2011)Lemaitre Vascular, Inc.2010-11-22
LeMaitre VascuTape Radiopaque Tape, Glow 'N Tell 30cm Tape, 100 strips Catalog Number: 110 recall (Z-0435-2011)Lemaitre Vascular, Inc.2010-11-22
LeMaitre VascuTape Radiopaque Tape, Glow 'N Tell 55cm Tape 20 strips Catalog Number: 1108- recall (Z-0436-2011)Lemaitre Vascular, Inc.2010-11-22
LeMaitre Vascular AnastoClip GC Vessel Closure System-Medium Size Models: 4007-02 Medium s recall (Z-0164-2011)Lemaitre Vascular, Inc.2010-10-28
LeMaitre Vascular AnastoClip GC Vessel Closure System-Large Size Models: 4007-03 Large siz recall (Z-0165-2011)Lemaitre Vascular, Inc.2010-10-28
CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedu recall (Z-0008-2008)Lemaitre Vascular, Inc.2007-10-04
Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is l recall (Z-0219-06)LeMaitre Vascular, Inc.2005-11-30
LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml, Length 60 cm. Latex recall (Z-0557-05)Lemaitre Vascular, Inc.2005-02-24
LeMaitre Embolectomy Catheter 3F Single Lumen, Balloon volume 0.2ml, Length 80 cm, Latex M recall (Z-0558-05)Lemaitre Vascular, Inc.2005-02-24
LeMaitre Embolectomy Catheter 4F Single Lumen, Balloon Volume 0.75 ml, Length 80 cm, Latex recall (Z-0559-05)Lemaitre Vascular, Inc.2005-02-24
LeMaitre Embolectomy Catheter 5F Single Lumen, Balloon Volume 1.5 ml, Length 80 cm, Latex recall (Z-0560-05)Lemaitre Vascular, Inc.2005-02-24
LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml , Length 80 cm Latex recall (Z-0561-05)Lemaitre Vascular, Inc.2005-02-24

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