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Open, Classified

Artegraft Collagen Vascular Graft; REF: AG1015;

FDA Recall Z-0289-2026 · Posted 2025-10-23

Recalling FirmLeMaitre Vascular, Inc.
Recall StatusOpen, Classified
Product CodeLXA
Date Initiated2025-09-25
Product Quantity1 unit

Reason for Recall

The device was incorrectly packed in the wrong size labeled outer packaging.

Firm Action

On September 25, 2025, an "URGENT: MEDICAL DEVICE RECALL" letter was sent to the customer. Actions to be taken: Check your inventory against the list of lots in this letter. Immediately quarantine any recalled devices. Complete and return the form provided even if you have no devices in inventory. If the product has been implanted, graft explantation/patient intervention is NOT required. Scan the reply form and send it to [email protected]. When a recalled device has been returned to LeMaitre Vascular, a replacement device will be provided. If you have transferred devices to another facility, please forward a copy of this recall letter to them. If you have any questions, contact Sr. Director, Quality Affairs, via email: [email protected] or at 732-422-8333 Monday through Friday, 8:00AM to 4:30 PM, Eastern Time.

Root Cause

Packaging change control

Distribution Pattern

US distribution to the state of: AR

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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