LeMaitre Vascular, Inc. recalls AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the…

Recall date

June 19, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3042-2018

FDA classification

Class II

Brand / firm

LeMaitre Vascular, Inc.

Sold / distributed

Distributed to accounts in FL, NV, OK, SC, and TX.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.