LEMAITRE VASCULAR INC

Previous wording

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.

Current wording

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. In October 2026, we participated in a virtual regulatory meeting with the FDA to discuss our corrective action plans, and we believe we demonstrated progress on those plans. The FDA will inspect our Artegraft facility again to review completion of 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 actio…

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