FDA-Device2018-09-19Class II
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.
LeMaitre Vascular, Inc.
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.
Sold states
Distributed to accounts in FL, NV, OK, SC, and TX.
Affected count
N/A
Manufactured in
63 2nd Ave, N/A, Burlington, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3042-2018Don't want to check this manually?
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