HIGH

LeMaitre Vascular Recalls Collagen Vascular Grafts Over Sourcing Issue

LeMaitre Vascular recalled 28 units of Artegraft Collagen Vascular Grafts on September 2, 2025. The recall affects multiple model numbers due to unapproved sourcing of raw materials. Patients and healthcare providers must stop using the device immediately and follow recall instructions.

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

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

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Product Details

The recall includes Artegraft Collagen Vascular Grafts with 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, and AG 1030. These products were distributed in various states including CA, CT, FL, GA, IL, MA, MS, NC, ND, NJ, NY, OK, PA, TN, TX, VA, and WA.

The Hazard

The recall stems from the use of bovine carotid arteries sourced from a supplier that lacked appropriate regulatory approval. This raises concerns about the safety and efficacy of the grafts.

Reported Incidents

No specific injury or incident counts have been reported related to this recall. However, the classification of this recall as Class II indicates a potential risk of serious injury.

What to Do

Patients and healthcare providers should stop using these grafts immediately. Contact LeMaitre Vascular, Inc. or your healthcare provider for further instructions.

Contact Information

For more information, call LeMaitre Vascular at 1-800-XXX-XXXX or visit their website at www.lemaitrevascular.com.

Key Facts

  • Recall date: September 2, 2025
  • Affected model numbers include AG 616 to AG 1030
  • 28 units recalled nationwide
  • Class II recall due to sourcing issues

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Model Numbers: (1) AG 616
(2) AG 630
(3) AG 636
(4) AG 640
(5) AG 645
+15 more
Affected States
ALL
Report Date
October 8, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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