Vascular Graft Recalled for Missing Regulatory Marks and Patient Documentation
LeMaitre Vascular is recalling Artegraft Collagen Vascular Grafts distributed internationally without CE and UKCA regulatory marks, patient leaflets, and implant cards. The devices were distributed with incorrect labeling and missing required patient information.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall involving labeling and documentation defects (missing regulatory marks and patient information) with no reported illness or injury. The hazard is documentation-related, fitting the rubric criterion for minor labeling errors without reported clinical harm.
Plain-English summary
The Artegraft Collagen Vascular Graft is a medical device intended to serve as a substitute blood vessel conduit for bypass or replacement of occluded or diseased arterial segments, or to establish a conduit for hemodialysis. LeMaitre Vascular, Inc. is recalling certain models of this device.
The recalled devices were distributed with incorrect labeling and were missing required regulatory markings (CE and UKCA marks) and patient information documents (patient leaflet and patient implant card). The affected models are AG630M, AG636M, AG730M, AG740M, and AG845M with specific lot numbers noted by the manufacturer.
The recall affects 10 units distributed internationally to Great Britain and Switzerland only. The devices were not distributed in the United States. The devices carry an expiration date of July 28, 2027.
The recalled product
- 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 c
- Manufacturer
- LeMaitre Vascular, Inc.
- Category
- Medical Device — Vascular Graft
- Hazard
- incorrect-labeling
- missing-ce-mark
- missing-ukca-mark
- missing-patient-documentation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- 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.
Distribution
Distribution scope not specified by the agency.
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