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U.S. Department of Health and Human Services

Class 2 Device Recall Artegraft

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 Class 2 Device Recall Artegraftsee related information
Date Initiated by FirmSeptember 25, 2025
Date PostedOctober 23, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0289-2026
Recall Event ID 97700
Product Classification Tissue graft of 6mm and greater - Product Code LXA
ProductArtegraft Collagen Vascular Graft; REF: AG1015;
Code Information REF: AG1015; UDI-DI: 00316837000343; Lot/Serial Number: 23MM581-016;
Recalling Firm/
Manufacturer		 LeMaitre Vascular, Inc.
206 N Center Dr
North Brunswick NJ 08902-4246
For Additional Information ContactTimothy Rodenberger
781-362-5449
Manufacturer Reason
for Recall		The device was incorrectly packed in the wrong size labeled outer packaging.
FDA Determined
Cause 2		Packaging change control
ActionOn 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.
Quantity in Commerce1 unit
DistributionUS distribution to the state of: AR
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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