LeMaitre Vascular Artegraft AG1015 Recall for 1 Unit Over Packing Error (2025)
The device was incorrectly packed in the wrong size labeled outer packaging.
1,320 recalls tagged with “fda regulated”.
The device was incorrectly packed in the wrong size labeled outer packaging.
potential for metal in product
potential for metal in product
cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall.
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall.
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall.
Lack of assurance of sterility.
Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.