LeMaitre Vascular Artegraft 10-Unit Recall 2025 for Labeling Errors
LeMaitre Vascular recalls 10 Artegraft Collagen Vascular Grafts distributed internationally to Great Britain and Switzerland, with no US distribution. The devices were labeled incorrectly and lacked CE and UKCA marks and missing patient documents. Healthcare providers and patients should stop using the devices and follow recall instructions immediately.
Quick Facts at a Glance
Recall Date
August 25, 2025
Hazard Level
HIGH
Brand
LeMaitre Vascular
Category
Health & Personal Care
Sold At
Unknown
At-Risk Groups
GENERAL
Hazard Information
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact LeMaitre Vascular, Inc. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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About This Product
The Artegraft Collagen Vascular Graft is used as a conduit for bypass or dialysis-related vascular procedures. It is distributed internationally and is intended for use by healthcare professionals in surgical settings.
Why This Is Dangerous
The hazard stems from incorrect labeling and missing patient information, which can affect safe usage and informed consent.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
Clinicians may lack essential regulatory documentation and patient information, possibly delaying or complicating vascular procedures.
Practical Guidance
How to identify if yours is affected
Verify model numbers AG630M, AG636M, AG730M, AG740M, AG845M on the device label.
Check that CE and UKCA marks are present on labeling.
Confirm the presence of an accompanying patient leaflet and patient implant card.
Where to find product info
Recall notification and enforcement page linked to the FDA enforcement report Z-0072-2026. Follow official recall notices for detailed steps.
What timeline to expect
Active recall with ongoing remediation. Replacement or remediation actions may take several weeks to finalize.
If the manufacturer is unresponsive
Escalate to hospital risk management or regulatory bodies if the company is slow to respond.
Document all communications and dates of contact.
How to prevent similar issues
Require CE/UKCA documentation checks for future medical devices.
Ensure patient leaflets and implant cards are included with devices.
Verify manufacturer recalls through official regulatory portals before use.
Documentation advice
Keep a copy of the recall notice, model numbers, device IDs, purchase records, and all correspondence with the manufacturer and healthcare providers.
Product Details
Product: Artegraft Collagen Vascular Graft
Model numbers: AG630M, AG636M, AG730M, AG740M, AG845M
Sold at: International distribution to Great Britain and Switzerland; no US distribution
Sold since: Unknown
Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
10 total units recalled
No US distribution
Recall date 2025-08-25
Report date 2025-10-15
Hazard: labeling without CE/UKCA marks and missing patient documents
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