LeMaitre Vascular Inc.

During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).

The guide tip can become damaged and result in the tip detaching.

Burrs (molding flash) on the cutter may tear the harvested vien

Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole, leading to the risk of the tip breaking off, and potentially be…

The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.

There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.

incorrect device size being listed on the impacted device packaging

Pouches from this lot are not sealed compromising the sterility

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…

The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch

Wire which deploys the loop may be come detached at the handle causing the device to be inoperable

US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Mislabeled with an incorrect expiration date

Blood blushing/leaking from the surface of the graft after implantation

Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.