LEMAITRE VASCULAR INC

Current report

In addition to the information set forth in this report, you should consider the risks and uncertainties discussed in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, which could materially affect our business, financial condition, or future results. The risk factors below supplement and update the risk factors and information discussed in our Annual Report on Form 10-K for the year ended December 31, 2025.

Current report

Even after our products have received marketing approval or clearance, our products and the tissue we process may be subject to recall. Licenses, registrations, approvals, and clearances could be withdrawn or suspended due to failure to comply with regulatory standards or the occurrence of unforeseen problems following initial approval.

Current report

Our products, services, marketing, sales, development activities, and manufacturing processes are subject to extensive and rigorous regulation by the FDA, by comparable agencies in foreign countries, and by other regulatory agencies and governing bodies. If those regulatory bodies believe that we have failed to comply with regulatory standards, there can be no assurance that any approval, licensure, or registration will not be subsequently withdrawn, suspended or conditioned upon extensive post-market study requirements, even after having received marketing approval or clearance or licenses and registrations. Further, due to the interconnectedness of the various regulatory agencies, particularly within the EU, there is also no assurance that withdrawal or suspension of any of our approvals, licenses, or registrations by any single regulatory agency will not cause one or more additional regulatory agencies to also withdraw or suspend their approval, license, or registration.

Current report

In the event that any of our products prove to be defective, we can voluntarily recall, or the FDA or foreign equivalent could require us to recall, any of our products. In the EU and UK, adverse event reporting requirements mandate that we report incidents which led or could have led to death or serious deterioration in health. Recalls, whether voluntary or required, could result in significant costs to us and significant adverse publicity. In severe instances, the FDA may also issue a warning letter, require the destruction of defective product, and/or order the suspension or cessation of manufacturing of defective product. Additionally, if someone is harmed by a malfunction or a product defect, we may experience product liability claims for such defects. Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time and capital and may harm our financial results. Future recalls or claims could also result in significant costs to us and significant adverse publicity, which could harm our ability to market our products in the future. For example, in April 2025, we voluntarily notified our regulatory bodies of an inadequate seal on the packaging of our TufTex Over-the-Wire, Pruitt Occlusion, and Pruitt Irrigation catheters, which may result in a compromised sterile barrier. Notice was provided to each of our customers of the inadequate seal, and customers were offered a product replacement for any existing inventory on hand. The financial impact of the voluntary notification is not expected to be material to our business. Additionally, in August 2025, the FDA issued a warning letter to us following an April 2025 inspection of our Artegraft facility in North Brunswick. In August 2025, we responded to the cited observations and since then have continued to implement corrective actions. In June 2026, the FDA concluded a re-inspection of our Artegraft facility and identified additional new inspectional observations, without commenting on the April 2025 cited observations. We have submitted responses to the FDA regarding these observations, continue to engage with the agency concerning the status of our remediation efforts and the warning letter, and expect to incur ongoing costs and devote management resources to addressing these matters. We believe that the FDA will likely inspect our Artegraft facility again to review our corrective action activities. To date, the financial impact of the warning letter and related regulatory activities has not been material to our business, and there has been no disruption to Artegraft sales. However, there can be no assurance that the FDA will find our corrective actions satisfactory, that additional inspections will not result in further observations or in enforcement actions, or that these matters will not adversely affect our operations, regulatory compliance, reputation or financial results.

Previous report

There have been no material changes to the risk factors we previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025. However, we cannot provide any assurance that any risk factor will not materialize.