Overview of recall records associated with LeMaitre Vascular, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 20, Class I: 1.
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…
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).
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…
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
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 Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
This page summarizes recall records in which the official source identifies LeMaitre Vascular, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
