Health & Personal Care
HIGH
FDA DEVICE
LeMaitre Vascular Artegraft AG1015 Recall for 1 Unit Over Packing Error (2025)
The device was incorrectly packed in the wrong size labeled outer packaging.
LeMaitre Vascular
The device
Brand hub
The device was incorrectly packed in the wrong size labeled outer packaging.
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.
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.