Collagen vascular grafts recalled over incorrect labels missing CE and UKCA marks
LeMaitre Vascular is recalling 10 Artegraft Collagen Vascular Grafts distributed with an incorrect label lacking CE and UKCA marks and without the patient leaflet and implant card.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: Scored 2 as a documentation and labelling problem: the record describes missing marks and paperwork with no product defect or reported harm.
Plain-English summary
Artegraft Collagen Vascular Grafts, model numbers AG630M, AG636M, AG730M, AG740M and AG845M, are being recalled. The Artegraft is intended to serve as a substitute conduit for blood where bypass or replacement of occluded or diseased arterial segments is required.
The devices were distributed with an incorrect label that lacked the CE and UKCA marks, and without the patient leaflet and patient implant card.
The recall covers 10 units. There was no US distribution; the product went to Great Britain and Switzerland. The FDA has classified the action as Class II.
The enforcement record describes labelling and documentation gaps rather than a defect in the grafts themselves, and reports no injuries. Facilities holding affected lots should follow LeMaitre's instructions.
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…
- Manufacturer
- LeMaitre Vascular, Inc.
- Category
- Medical Device — Vascular graft
- Affected units
- 10
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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