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U.S. Department of Health and Human Services

Class 2 Device Recall Artegraft Collagen Vascular Graft

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 Class 2 Device Recall Artegraft Collagen Vascular Graftsee related information
Date Initiated by FirmAugust 25, 2025
Date PostedOctober 08, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0072-2026
Recall Event ID 97567
Product Classification Tissue graft of 6mm and greater - Product Code LXA
ProductArtegraft 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.
Code Information 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.
Recalling Firm/
Manufacturer		 LeMaitre Vascular, Inc.
206 N Center Dr
North Brunswick NJ 08902-4246
For Additional Information ContactTimothy Rodenberger
732-422-8333
Manufacturer Reason
for Recall		Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
FDA Determined
Cause 2		Process control
ActionLeMaitre 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 Commerce10 units
DistributionNo US distribution. International distribution to Great Britian and Switzerland.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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