Marquet Cardiovascular EVH Device Lawsuit Investigation [2025 Update]

Marquet Cardiovascular EVH Device Recall Information

In September 2024, Maquet Cardiovascular, a subsidiary of Getinge, initiated a recall of its VasoView HemoPro 1 and 1.5 Endoscopic Vessel Harvesting (EVH) Systems due to safety concerns.

The recall was prompted by reports of silicone detaching from the jaws of the harvesting tool during use, leading to device malfunction and the introduction of silicone debris into patients.

This issue has resulted in at least 17 serious injuries, including three cases where the silicone debris could not be retrieved.

The U.S. Food and Drug Administration (FDA) classified this as a Class I recall, indicating a situation where there is a reasonable probability that the use of these products could cause serious adverse health consequences or death.

Healthcare providers are advised to consider alternative devices and to exercise caution when using any EVH systems, inspecting them for signs of damage or silicone peeling prior to use.

Key Points of the Recall:

• Recall Initiation: September 2024 by Maquet Cardiovascular (Getinge subsidiary).
• Affected Devices: VasoView HemoPro 1 and 1.5 EVH Systems.
• Reason for Recall: Silicone detachment from the jaws during use.
• Reported Injuries: 17 serious injuries; silicone debris unretrievable in 3 cases.
• FDA Classification: Class I recall.
• Supply Impact: EVH devices added to FDA’s medical device shortage list.
• Recommendations for Providers: Seek alternative devices; inspect EVH systems for damage or silicone peeling before use.
• Patient Safety Concerns: Potential for procedural delays and conversion to more invasive procedures.

Potential Injuries Caused by Defective EVH Devices

Patients and healthcare providers have reported several injuries linked to the malfunctioning Maquet Cardiovascular EVH devices.

These injuries include:

• Silicone Debris Complications: Silicone fragments introduced into the patient’s body may cause inflammation, foreign body reactions, or long-term complications if not retrieved.
• Infection Risk: Device failure during surgery can increase the likelihood of infections at the surgical site.
• Extended Recovery Times: Conversion to open harvesting procedures due to device failure often leads to increased recovery times and additional scarring.
• Emotional and Financial Stress: Patients and families may face emotional challenges and financial burdens due to additional surgeries or complications.

What is the Marquet Cardiovascular EVH Device and Why is it Used?

The Maquet Cardiovascular Endoscopic Vessel Harvesting (EVH) devices, like the VasoView HemoPro systems, are medical tools used during certain types of surgical procedures, particularly heart surgeries like coronary artery bypass grafting (CABG).

Coronary artery bypass grafting is often needed when the arteries supplying blood to the heart are blocked or severely narrowed due to conditions like coronary artery disease.

These tools are designed to harvest (remove) a healthy blood vessel, usually from the patient’s leg (saphenous vein) or arm (radial artery).

The harvested vessel is then used to create a bypass around blocked or damaged arteries in the heart.

This restores proper blood flow.

Instead of making large, open incisions to remove the vessel, surgeons use these devices to perform the procedure endoscopically, meaning through small cuts with the help of a camera.

The device includes a small, tube-like tool with a camera and cutting instruments, allowing for precise removal of the vessel while minimizing damage to surrounding tissues.

In essence, these tools make heart surgery less invasive and improve patient recovery, but recent malfunctions have raised safety concerns for both surgeons and patients.

TorHoerman Law: Investigating Injuries Linked to Marquet Cardiovascular EVH Devices

TorHoerman Law is actively investigating claims of injuries linked to defective Maquet Cardiovascular EVH devices.

Reports of silicone detachment and device malfunctions during surgery have caused serious complications for patients, including prolonged recovery times and the need for additional procedures.

These issues stem from the recall of the VasoView HemoPro 1 and 1.5 systems, classified by the FDA as a Class I recall due to the potential for severe health consequences.

Our team is dedicated to helping individuals affected by these defective devices seek justice and compensation for their injuries.

With extensive experience in medical device litigation, we are ready to provide the support you need.

If you or a loved one suffered injuries from a recalled EVH device, contact TorHoerman Law today for a free consultation.

Call us now or use the chat feature on this page to get started.