FDA Issues New Recall for Maquet Cardiovascular Surgical Devices Following Additional Safety Concerns

The U.S. Food and Drug Administration (FDA) has announced another Class I recall—the most serious recall—for Maquet Cardiovascular’s endoscopic vessel harvesting (EVH) devices. This latest recall applies to all unexpired lots of the VasoView HemoPro 2 Endoscopic Vessel Harvesting System and the VasoView HemoPro 2 (with VasoShield) Endoscopic Vessel Harvesting System.

The recall stems from persistent safety concerns about heater wires becoming bent or detached and silicone peeling or separating from the devices. These issues have been linked to seven new serious injuries—four caused by heater wire malfunctions and three by detached silicone. While no patient deaths have been reported, the FDA warns that continued use without adherence to updated guidelines could result in serious injury or death.

Ongoing Issues with EVH Devices
This recall follows a similar action in November 2024, when Maquet Cardiovascular recalled VasoView HemoPro 1.5 and VasoView HemoPro 1 devices due to silicone components breaking off during use. That recall, linked to 17 serious injuries, required affected devices to be returned. This latest recall addresses additional issues identified during the FDA’s earlier investigation.

Customers are urged to review the updated instructions for use to mitigate risks and ensure patient safety. For more information, healthcare professionals can contact Maquet Cardiovascular or visit the FDA’s recall website.

Contact The Ammons Law Firm for Legal Representation Involving Cardiovascular Devices

If you or a loved one has been injured or killed due to a defective cardiovascular device, the Ammons Law Firm is here to help. Our dedicated legal team understands the devastating impact of these tragic incidents on families, and we have a proven track record of holding manufacturers accountable for defective products.

Contact the Ammons Law Firm today for a free consultation to discuss your case and learn about your legal rights. You may be entitled to compensation for medical expenses, lost wages, pain and suffering, and other damages related to the defective product.

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The Ammons Law Firm represents clients nationwide in personal injury and wrongful death litigation.

 Disclaimer: This post is not legal advice. Information contained in this blog was compiled from third-party sources or is the opinion of the author. Please inform us immediately if false or misleading information is contained in this post.