Quick Facts at a Glance
- Recall Date
- September 2, 2025
- Hazard Level
- HIGH
- Brand
- LeMaitre Vascular
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- 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
- AG 616, AG 630, AG 636, AG 640, AG 645, AG 715, AG 730, AG 735 +7 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 2, 2025
Reported by FDA DEVICE
October 8, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.
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: Letter
About This Product
Artegraft Collagen Vascular Grafts are implanted vascular grafts used in vascular surgery. They are designed to replace or repair diseased blood vessels.
Why This Is Dangerous
The issue arises from bovine carotid arteries used in production, sourced from a supplier not reviewed by the appropriate regulatory authority, potentially impacting safety and regulatory compliance.
Industry Context
This recall is not part of a broader industry pattern.
Practical Guidance
How to identify if yours is affected
- Review listed model numbers AG 616 through AG 1030.
- Check packaging or labeling for the Artegraft Collagen Vascular Graft name and model.
- Consult your clinician if you are unsure whether your graft is affected.
Where to find product info
FDA recall page and LeMaitre Vascular instructions. Manufacturer communications and clinical notes with device labeling.
What timeline to expect
Remedies typically follow manufacturer recall instructions; processing times for replacements or refunds vary. No specific timeline provided in this記.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer.
- Escalate to FDA via MedWatch to report issues with implants or recall process.
How to prevent similar issues
- Require supplier qualification and regulatory approvals for raw materials before implantation.
- Verify regulatory compliance documentation for graft materials in future purchases.
Documentation advice
Keep recall notices, model numbers, UDI codes, and any correspondence with the manufacturer and healthcare providers.
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Product Details
Model numbers: AG 616, AG 630, AG 636, AG 640, AG 645, AG 715, AG 730, AG 735, AG 740, AG 745, AG 750, AG 830, AG 840, AG 1015, AG 1030. Sold nationwide in the United States (CA, CT, FL, GA, IL, MA, MS, NC, ND, NJ, NY, OK, PA, TN, TX, VA, WA). When sold: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 15 model numbers listed: AG 616, AG 630, AG 636, AG 640, AG 645, AG 715, AG 730, AG 735, AG 740, AG
- 745, AG 750, AG 830, AG 840, AG 1015, AG 1030
- Distributed nationwide in 17 states: CA, CT, FL, GA, IL, MA, MS, NC, ND, NJ, NY, OK, PA, TN, TX, VA,
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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