Z-0072-2026Class II

Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The...

Name: Z-0072-2026 Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The...
Creator: LeMaitre Vascular, Inc.
Published: 2025-08-25
License: https://open.fda.gov/license/

LeMaitre Vascular Inc. / initiated 2025-08-25 / Open, Classified / root cause: manufacturing process

FDA source

LeMaitre Vascular, Inc. began a recall of Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a substitute... on 2025-08-25. FDA classified it as Class II and gives the reason as "Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0072-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-25
Posted: 2025-10-08
Recalling firm: LeMaitre Vascular Inc.
Product: 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.
Product code: LXA Tissue Graft Of 6mm And Greater
Reason for recall: Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: LeMaitre Vascular notified consignees on about 08/25/2025 via letter. Consignees were instructed to identify any affected units in inventory, quarantine those affected units, and arrange for their return. If the product has been implanted, graft explantation/patient intervention is not required. Consignees were also instructed to notify all consignees/customers who should be aware and where affected product has been transferred. Consignees were requested to complete and return the Customer Reply Form. Distributors were requested to indicate that they have quarantine affected units in stock and notified all customers who have received the product.
Quantity in commerce: 10 units
Distribution: No US distribution. International distribution to Great Britian and Switzerland.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0072-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0072-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-15	2025-10-08

Product code LXA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)