The FDA has posted 7 enforcement recalls from LeMaitre Vascular, Inc. since 2025, none of them Class I (most serious). Most recent report: Mar 25, 2026.
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).
Firm name as filed with the FDA: “LeMaitre Vascular, Inc.”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.