Reported Oct 15, 2025 · Ongoing
Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is…
LeMaitre Vascular, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LeMaitre Vascular, Inc. · 206 N Center Dr · North Brunswick, NJ · 08902-4246
Is this the product you have?
- Artegraft Collagen Vascular Graft
- Model/Catalog/Part NumbersAG630M, 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
- Lot codes and dates
5 of 5 products
Products covered by this recall # Barcodes Product as published 1 00316837000015AG630M, 00316837000015 (24H361-021, 24H361-022, 24HH359-016). 2 00316837000022AG636M, 00316837000022 (24H380-009). 3 00316837000060AG730M, 00316837000060 (24H380-014, 24H380-004). 4 00316837000084AG740M, 00316837000084 (24H380-003, 24H380-002). 5 00316837000138AG845M, 00316837000138 (24HH350-017, 24HH359-011). Expiration date: 28 Jul 2027. - Amount recalled
- 10 units
Why it was recalled
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
This product could cause temporary or reversible health problems — stop using it.
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