Edwards Lifesciences Arterial Cannula Injury Lawsuit Lawyers

Nationwide Concerns Over Exposed Wire Defects in Edwards Lifesciences Cannulae and Potential Legal Claims for Victims

The U.S. Food and Drug Administration (FDA) has classified the Edwards Lifesciences arterial cannula recall as the most severe level due to a defect that could cause serious injury or death. These devices, used during cardiopulmonary bypass to deliver oxygenated blood to patients, may have exposed wire at the cannula tip, creating a significant risk of puncturing arteries, causing major bleeding, tissue damage, and inadequate blood flow.

Although no deaths have been reported, the risk is considered life-threatening, and patients who have undergone bypass surgery using these devices could be affected.

Details of the Recall and Affected Devices

The recall affects multiple models of the OptiSite Arterial Perfusion Cannula and Peripheral Femoral Arterial Cannula, specifically:

• OPTI16 (UDI-DI 00690103180558)
• OPTI18 (UDI-DI 00690103180565)
• FEMII016A (UDI-DI 00690103031232)
• FEMII016AS (UDI-DI 00690103168341)
• FEMII018A (UDI-DI 00690103031256)
• FEMII018AS (UDI-DI 00690103168358)

Edwards Lifesciences began notifying hospitals in May 2025, urging them to immediately remove the affected devices from circulation and work with company representatives for product returns and credit.

Potential Injuries Linked to the Defective Arterial Cannulae

Patients who were treated with defective cannulae face potential complications such as:

• Arterial puncture leading to significant bleeding
• Severe tissue damage at the insertion site
• Impaired blood circulation during bypass surgery
• Blood cell destruction (hemolysis)
• Post-surgical complications requiring additional medical intervention
• Potentially life-threatening outcomes due to compromised perfusion

Even without reported deaths to date, the exposure of internal wire in a device designed for direct arterial use poses a grave risk to patient safety.

Legal Options for Patients Harmed by Edwards Lifesciences Devices

Medical device manufacturers are required to ensure their products are safe and thoroughly tested before being used in patients. When devices cause harm, victims may have legal claims to recover compensation for:

• Medical bills and corrective surgeries
• Pain, suffering, and emotional distress
• Lost wages or diminished earning capacity
• Wrongful death claims in fatal cases

Taking legal action not only seeks justice for victims but also pressures manufacturers to improve device safety and prevent similar incidents in the future.

What to Do If You or a Loved One May Have Been Affected

If you believe you or a family member experienced complications linked to an Edwards Lifesciences arterial cannula, you should:

• Request and review your medical records to confirm if the affected device was used.
• Monitor for unusual post-surgical symptoms and seek immediate medical attention if necessary.
• Contact an experienced personal injury attorney to evaluate your potential claim against the manufacturer.

Timely legal action can preserve vital evidence and strengthen your case.

Contact Parker Waichman LLP For A Free Case Review

If you or someone close to you suffered harm due to a defective Edwards Lifesciences arterial cannula, you may have grounds for legal action. Parker Waichman LLP is a national personal injury law firm dedicated to helping victims of defective medical devices.

Call 1-800-YOUR-LAWYER (1-800-968-7529) today for a free consultation and learn how we can help you pursue justice and compensation for your injuries. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you and provide a free consultation.