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Recall Observatory FDA recall evidence

Device 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.

Z-3042-2018

June 19, 2018

Class II

Product summary

Firm
LeMaitre Vascular, Inc.
Event
Event 80627
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-3042-2018

Official wording

Reason: 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.

Code information: AGC2134

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.