Artegraft Collagen Vascular Graft; REF: AG1015;
This recall is currently active, issued October 23, 2025. It was issued by Lemaitre Vascular, Inc..
- Company
- Lemaitre Vascular, Inc.
- Recall Initiated
- September 25, 2025
- Posted
- October 23, 2025
- Recall Number
- Z-0289-2026
- Quantity
- 1 unit
- Firm Location
- North Brunswick, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
The device was incorrectly packed in the wrong size labeled outer packaging.
Distribution
US distribution to the state of: AR
Lot / Code Info
REF: AG1015; UDI-DI: 00316837000343; Lot/Serial Number: 23MM581-016;
Root Cause
Packaging change control
Action Taken
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 recalls@lemaitre.com. 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: mnelson@lemaitre.com or at 732-422-8333 Monday through Friday, 8:00AM to 4:30 PM, Eastern Time.