LeMaitre Vascular Artegraft Collagen Vascular Graft recall — FDA Z-0072-2026
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
Overview of recall records associated with LeMaitre Vascular, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 5.
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).
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.