Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegr
Summary
The FDA issued a Class II for Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, by LeMaitre Vascular, Inc.. Reason: Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card..
Details
Source
Device Recall
External ID
Z-0072-2026
Action Date
2025-10-15
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: Model/Catalog/Part Number, UDI-DI (lot Numbers): 1. AG630M, 00316837000015 (24H361-021, 24H361-022, 24HH359-016). 2. AG636M, 00316837000022 (24H380-009). 3. AG730M, 00316837000060 (24H380-014, 24H380-004). 4. AG740M, 00316837000084 (24H380-003, 24H380-002). 5. AG845M, 00316837000138 (24HH350-017, 24HH359-011). Expiration date: 28 Jul 2027.
Quantity Affected: 10 units
Reason for Recall
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
Distribution
No US distribution. International distribution to Great Britian and Switzerland.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-25
Company
North Brunswick, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 161 device recalls issued in the same week, part of 403 device-related FDA actions this month.
LeMaitre Vascular, Inc. has 11 FDA actions in our database, including 10 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (LeMaitre Vascular, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does LeMaitre Vascular, Inc. have FDA actions?
LeMaitre Vascular, Inc. has 11 FDA actions in our database, including 10 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0072-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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