LeMaitre Vascular, Inc.

7 FDA enforcement actions

7 Total Recalls

0 Class I

7 Class II

0 Class III

Firm Details

Product Types: device
States: NJ, MA

All Recalls

Class II: Risk 09/25/2025 device

The device was incorrectly packed in the wrong size labeled outer packaging.
Class II: Risk 09/02/2025 device

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.
Class II: Risk 08/25/2025 device

Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
Class II: Risk 04/11/2025 device

During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Class II: Risk 04/11/2025 device

During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Class II: Risk 04/11/2025 device

During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Class II: Risk 04/17/2024 device

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

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.