Edwards OptiSite and Femoral Arterial Cannula Lawsuit Lawyers

Understanding the Nationwide Recall of Edwards OptiSite and Femoral Arterial Cannula Devices and What It Means for Patients

A national recall of arterial cannula devices manufactured by Edwards Lifesciences has raised serious safety concerns for patients undergoing cardiopulmonary bypass procedures. According to a warning issued by the U.S. Food and Drug Administration (FDA), the affected devices have been classified under a Class I recall indicating a risk of severe injury or death. These cannulae are used to facilitate arterial perfusion of oxygenated blood during bypass surgeries. The structural failure discovered at the cannula tip could lead to internal bleeding, inadequate blood flow, or damage to surrounding tissue.

The issue stems from a manufacturing defect involving the wire-reinforcement coil at the cannula tip. In some cases, a 3mm to 4mm section of the coil was found to have separated and become exposed. This can result in punctured arteries, excessive bleeding, hemolysis (destruction of red blood cells), and other severe complications. While no injuries or deaths have been reported as of May 20, 2025, the risk is serious enough that Edwards has urged all healthcare providers to remove the affected products from circulation immediately.

Affected Products and Where They Were Used

The affected devices include the OptiSite Arterial Perfusion Cannula and certain models of the Peripheral Femoral Arterial Cannula, both commonly used in hospitals and surgical centers nationwide. These devices were marketed for use in adult patients undergoing open-heart surgeries and other cardiopulmonary procedures.

The following product codes are part of the recall:

• OptiSite Arterial Perfusion Cannula: OPTI16 (00690103180558), OPTI18 (00690103180565)
• Peripheral Femoral Arterial Cannula: FEMII016A (00690103031232), FEMII016AS (00690103168341), FEMII018A (00690103031256), FEMII018AS (00690103168358)

Each of these products may have been used in procedures across major hospital systems and specialty surgical centers. Patients may not even be aware that one of these devices was used during their procedure. Hospitals were instructed to stop using the products and return them to Edwards Lifesciences for correction.

FDA Class I Recall: What It Means for Patients and Families

The FDA categorizes Class I recalls as the highest level of risk, reserved for defects likely to cause serious adverse health consequences or death. While no injuries have been reported so far, the risk remains real. Cannulae are placed directly into arteries and play a critical role in life-saving surgical procedures. A manufacturing defect in these devices can be catastrophic.

Patients who underwent surgery involving cardiopulmonary bypass between 2024 and 2025 may have unknowingly been exposed to these defective devices. Warning signs of potential complications include unusual pain, swelling, signs of infection, excessive bruising, fatigue, shortness of breath, or anemia. If any of these symptoms have appeared following surgery, urgent medical evaluation is recommended.

Potential Legal Claims and Compensation for Victims

Medical device manufacturers have a legal responsibility to ensure their products are safe and free from defect before being used on patients. When a company fails in this duty, whether due to negligent design, quality control issues, or delayed recalls, victims may have a valid claim for compensation.

Victims of defective medical devices like the recalled Edwards cannulae may be entitled to compensation for:

• Medical expenses, including corrective surgeries
• Pain and suffering
• Lost wages or reduced earning capacity
• Long-term rehabilitation and therapy
• Emotional trauma and distress

Legal claims may also include product liability suits against the manufacturer and, in some cases, the healthcare provider if they failed to follow recall protocols in a timely manner.

What to Do If You or a Loved One Was Affected

If you underwent a cardiac or bypass procedure within the last 18 months, you may wish to contact your surgeon or hospital and ask whether a recalled cannula device was used. Hospitals are required to notify affected patients, but not all do so promptly. Keep a record of your surgical reports and discharge papers. If you’re experiencing unexplained symptoms, a second opinion or additional diagnostic testing may reveal if device-related injury occurred.

It is also important to speak with a personal injury attorney experienced in medical device claims. Cases involving defective surgical products can be complex and require immediate action to preserve your rights.

Contact Parker Waichman LLP For A Free Case Review

If you or someone close to you had open-heart surgery or cardiopulmonary bypass and later experienced complications, you may be entitled to financial compensation. Parker Waichman LLP is a national personal injury law firm with extensive experience handling medical device recall cases. Our attorneys are standing by to assist you. Call 1-800-YOUR-LAWYER (1-800-968-7529) today for a free and confidential consultation. We’re here to protect your rights and help you recover. Don’t wait, call now.