Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715

FDA device recall Z-0034-2026 · posted 2025-10-02 · Open, Classified

Recall details

Recalling firm

LeMaitre Vascular, Inc.

Reason for recall

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.

Action taken

On September 2, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: 1. Check your inventory against the list of lots in this letter. Immediately quarantine any recalled devices. 2. Complete and return attached response form. 3. If the product has been implanted, graft explantation/patient intervention is NOT required. 4. When a recalled device has been returned to LeMaitre Vascular, a replacement device will be provided. 5. If you have transferred devices to another facility, please forward a copy of this recall letter to them. If you have any questions, contact Monte Nelson; mnelson@lemaitre.com; 732-422-8333 Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

LXA

Quantity affected

28 units

Distribution

US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, MS, NC, ND, NJ, NY, OK, PA, TN, TX, VA, WA.

Date initiated

2025-09-02

Date posted

2025-10-02

Location

North Brunswick, NJ