LeMaitre Vascular, Inc.: Medical Device Recall in 2018 - (Recall #: Z-3042-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 19, 2018

Date Posted: September 19, 2018

Recall Number: Z-3042-2018

Event ID: 80627

Reason for Recall:

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.

Status: Terminated

Product Quantity: N/A

Code Information:

AGC2134

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated