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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- LeMaitre Vascular
- Product type
- Vascular Graft
- Model numbers
- AG630M, AG636M, AG730M, AG740M, AG845M
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 25, 2025
Reported by FDA DEVICE
October 15, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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.
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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
- Hazard: labeling without CE/UKCA marks and missing patient documents
- Class II device
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Safety Guide
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