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Seven New Injuries Reported Due to Silicone Peeling and Heater Wire Defects
Maquet Cardiovascular, a subsidiary of Getinge, has expanded its recall of endoscopic vessel harvesting (EVH) devices due to ongoing safety issues. The recall includes all unexpired lots of the VasoView HemoPro 2 Endoscopic Vessel Harvesting System and the VasoView HemoPro 2 (with VasoShield) Endoscopic Vessel Harvesting System. The U.S. Food and Drug Administration (FDA) classified this recall as Class I, the most serious type, indicating a significant risk of severe injury or death.
The recall stems from defects in the devices' heater wires and silicone components. The heater wires have been reported to bend or detach, while the silicone can peel or detach from the device. These issues have resulted in seven serious injuries—four linked to the heater wire malfunction and three related to the silicone detachment.
FDA’s Recall Guidelines and Safety Recommendations
The FDA has not mandated the return of these devices but has issued updated instructions to reduce the risks associated with their use. Healthcare providers are urged to inspect the devices for visible damage or irregularities before, during, and after use. Specifically, users are advised to:
- Examine the devices for silicone peeling, rough edges, or other damage.
- Monitor for any signs of malfunction during use, including detached silicone components or heater wire issues.
- Stop using the device immediately if damage occurs or components detach.
- Locate and remove any detached parts that may remain in the patient.
- Monitor patients for complications such as delayed pain, infection, or allergic reactions.
These enhanced precautions aim to mitigate risks, but the recall raises concerns about the safety and reliability of these devices in critical surgical applications.
Previous Recalls and Escalating Concerns
This latest recall follows a similar action in November 2024, when Maquet Cardiovascular recalled its VasoView HemoPro 1 and HemoPro 1.5 devices after 17 serious injuries were reported due to silicone parts breaking off during the vessel harvesting process. At that time, the FDA recommended the immediate return of affected devices.
In this subsequent recall, the FDA cited ongoing issues identified during its review of the earlier recall. Despite the updated instructions, the recurring safety problems highlight a troubling pattern with these devices and their potential to cause harm during surgical procedures.
How These Devices Have Harmed Patients
The defects in Maquet Cardiovascular’s EVH devices have caused significant harm to patients undergoing surgery. Silicone peeling from the device’s jaws can lead to the introduction of foreign materials into the body, increasing the risk of infections, allergic reactions, and other complications. If left undetected, detached silicone parts can migrate, potentially causing internal damage or requiring additional surgical interventions to locate and remove the fragments.
Similarly, heater wire malfunctions, such as bending or detachment, can compromise the device's performance. This can lead to improper vessel harvesting, prolonged surgical times, or incomplete procedures, increasing risks for both patients and surgeons.
Patients affected by these issues may experience prolonged recovery times, unexpected medical expenses, and emotional distress. In severe cases, complications arising from these defects could lead to long-term health problems or require additional surgeries, further increasing the physical and financial burdens on victims.
Legal Rights and Filing a Lawsuit
Patients harmed by defective medical devices like Maquet’s EVH systems may have the right to pursue compensation through a product liability lawsuit. Manufacturers are legally obligated to ensure their products are safe for use and free from defects. When they fail in this duty, they can be held liable for any harm caused.
Filing a lawsuit involves several key steps:
First, victims must demonstrate that they were harmed by the defective device. This often requires medical records, evidence of the defect, and expert testimony linking the injury to the device. The complaint is then filed in court, outlining the manufacturer’s negligence and the damages sought by the plaintiff.
The discovery phase follows, during which both parties exchange evidence and gather information to support their claims. Settlement negotiations may occur at any point, with the goal of reaching an agreement without the need for a trial. If a settlement cannot be reached, the case proceeds to trial, where a judge or jury determines liability and awards damages.
Why Legal Representation Is Essential
Product liability cases involving medical devices are complex, requiring an in-depth understanding of medical technology, regulatory standards, and legal principles. An attorney can provide invaluable support by investigating the defect, gathering evidence, and building a strong case against the manufacturer. They can also negotiate effectively to secure fair compensation or advocate for the plaintiff in court.
Without an attorney, victims risk being undercompensated or overwhelmed by the legal and procedural challenges of pursuing a claim. Legal representation ensures that the manufacturer is held accountable and that victims receive the compensation they need to recover.
Damages Recoverable in a Product Liability Lawsuit
Victims of defective medical devices like Maquet’s EVH systems may be entitled to recover several types of damages, including:
- Medical Expenses: Reimbursement for surgeries, treatments, and ongoing medical care required to address complications caused by the defective device.
- Lost Wages: Compensation for income lost due to extended recovery periods or the inability to work.
- Pain and Suffering: Damages for physical pain, emotional distress, and reduced quality of life resulting from the injury.
- Punitive Damages: In cases of gross negligence, additional damages may be awarded to punish the manufacturer and deter future misconduct.
If you or a loved one suffered harm due to Maquet’s defective endoscopic vessel harvesting devices, you may be entitled to compensation. The national product injury law firm Parker Waichman LLP is committed to fighting for justice on behalf of victims harmed by defective medical products.
Contact Parker Waichman LLP For A Free Case Review
Call 1-800-YOUR-LAWYER (1-800-968-7529) today for a free, no-obligation consultation. Let Parker Waichman LLP help you pursue the justice and compensation you deserve. Regardless of your location or where your injury occurred, our national product injury law firm is ready to assist you.
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