Data / Medical devices / United States / Lemaitre Vascular, Inc.
Lemaitre Vascular, Inc.: FDA-registered device maker in N Brunswick, NJ, United States, 1 PMA approval
Lemaitre Vascular, Inc. is registered with the FDA (registration 2247686) in N Brunswick, NJ, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated August 1, 1979. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2247686
- FEI number
- 1000121696
- Address
- 206 North Center DR., N Brunswick, NJ, United States, 08902
- Owner or operator
- LeMaitre Vascular, Inc. (9006148)
- Roles
- Manufacturer
- First device listed
- December 31, 2007
- Registered through
- 2027
- Brand names listed
- Artegraft Bovine Carotid Artery (BCA), Artegraft Collagen Vascular Graft, Artegraft Vascular Graft
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Tissue Graft Of 6mm And Greater | LXA | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| August 1, 1979 | N16837 | ARTEGRAFT{TM} AND REINFORCED ARTEGRAFT{TM} | LXA | 34 | October 15, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 10, 2026 | 98409 | Class II | Ongoing | Artegraft Vascular Graft; REF#: AG740 | Labeling mix-up resulting in the incorrect lot outer packaging of product. | accessdata.fda.gov |
| September 25, 2025 | 97700 | Class II | Ongoing | Artegraft Collagen Vascular Graft; REF: AG1015 | The device was incorrectly packed in the wrong size labeled outer packaging. | accessdata.fda.gov |
| September 2, 2025 | 97518 | Class II | Ongoing | 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 10 | The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority. | accessdata.fda.gov |
| August 25, 2025 | 97567 | Class II | Ongoing | 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 disea | Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card. | accessdata.fda.gov |
Updated October 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.