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LeMaitre Vascular, Inc. recalls AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the
Recalled September 19, 2018 · FDA recall Z-3042-2018 · LeMaitre Vascular
Hazard
The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided lists some indications which are not cleared by the FDA for devices distributed in the United States: 1) closure of arteriotomies and veinotomies, 2) attachment of synthetic vascular prostheses, and 3) approximation of dural tissue. · FDA Class II
Units
N/A
Sold at
Distributed to accounts in FL, NV, OK, SC, and TX.
Description
The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided lists some indications which are not cleared by the FDA for devices distributed in the United States: 1) closure of arteriotomies and veinotomies, 2) attachment of synthetic vascular prostheses, and 3) approximation of dural tissue.
Product
AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the forming of an anastomosis or closing of a vessel with possible intraluminal penetration.
Manufacturer(s)
LeMaitre Vascular, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →