Lemaitre Vascular, Inc.

Labeling mix-up resulting in the incorrect lot outer packaging of product.

The device was incorrectly packed in the wrong size labeled outer packaging.

Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.

The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.

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

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

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 becoming lost in the blood vessel.