Edwards Lifesciences OptiSite Arterial & FEM-Flex II Femoral Arterial Cannula Lawsuit Lawyers

Understanding the Risks of Recalled Cardiac Surgery Tools and How Injured Patients Can Pursue Legal Action

Potentially Deadly Surgical Tools Recalled from New York Hospitals and Beyond

In July 2025, Edwards Lifesciences issued a massive recall affecting more than 61,000 arterial cannulae, critical devices used in cardiopulmonary bypass procedures. These recalls, now classified by the U.S. Food and Drug Administration (FDA) as Class I, the highest risk level, have raised serious safety concerns for patients undergoing open-heart surgery in New York and across the country. Specifically, these recalls target two widely used products: the OptiSite Arterial Cannula and the FEM-Flex II Femoral Arterial Cannula.

According to the FDA, the use of these devices may lead to serious injury or death. The issue involves a 3–4 mm wire located near the cannula’s tip that may become exposed during use. If this happens, the exposed wire could cause severe tissue damage, internal bleeding, or other life-threatening surgical complications.

Although no patient injuries have been reported yet, the classification of this recall as Class I underscores the real and immediate threat posed to anyone who has undergone or will undergo cardiac procedures involving these devices. For patients and families who may have been affected, it is essential to understand the risks and legal rights involved.

What Is a Cannula and Why Is It Critical in Heart Surgery?

A cannula is a flexible tube inserted into the body to deliver or remove fluids or to serve as a passage for surgical instruments. In cardiac surgeries such as coronary artery bypass grafting (CABG) or valve replacements, arterial cannulae are used to reroute blood and oxygen outside the body through a heart-lung machine. These devices are literally life-support tools. If one malfunctions, it can have catastrophic results.

The OptiSite and FEM-Flex II cannulae are designed to withstand pressure and movement during surgery. A failure in these tools, such as an exposed internal wire, can cause mechanical injuries to arteries or nearby tissues, introduce air bubbles into the bloodstream (air embolism), or damage the heart itself. Each of these scenarios poses extreme danger and can lead to irreversible harm, long-term disability, or death.

Patients in New York who underwent cardiac surgery with these recalled devices may not know if they were exposed to the risk. Because these surgeries are often performed under anesthesia, many patients are unaware of the specific tools used. That’s why it is critical to investigate whether any harm experienced post-surgery could be tied to a defective device.

FDA’s Class I Recall Classification: Why It Matters

A Class I recall is the most serious type issued by the FDA. It is reserved for situations where the use of a medical device could cause serious adverse health consequences or death. This classification means the government recognizes the high risk involved.

While Edwards Lifesciences claims that the defect was caught during routine quality checks and no injuries occurred, the issuance of a Class I recall shows that the FDA found sufficient evidence to determine that the devices are dangerous. The agency rarely assigns this level of recall unless there is a clear, scientifically grounded concern about patient safety.

For New York patients who experienced unexplained complications after heart surgery, such as prolonged hospital stays, internal bleeding, or vascular injuries, it is critical to evaluate whether a defective cannula was used. These complications may have been attributed to other causes at the time but could in fact be related to this defective product.

Legal Rights of Injured Patients and Families

If you or a loved one was harmed during or after cardiac surgery and suspect the use of a recalled Edwards Lifesciences cannula, you may have the right to pursue a product liability claim. Manufacturers of medical devices are legally obligated to ensure their products are safe for their intended use. When a defect causes harm, the company can be held accountable under strict liability, negligence, or breach of warranty claims.

A product liability lawsuit can help recover compensation for:

• Medical expenses
• Lost wages
• Long-term care
• Pain and suffering
• Loss of consortium
• Wrongful death damages (in fatal cases)

New York patients who underwent surgery between early 2024 and mid-2025 should be especially alert, as these cannulae were widely distributed during this period. Because the devices were also sold internationally, other families outside New York may also be impacted.

How to Know If You Were Affected

Hospitals and surgical centers may not immediately disclose that a recalled product was used. The recall instructs medical providers to review their inventory and return affected products, but there is no requirement to notify individual patients. This lack of transparency places the burden on families to investigate their own medical history.

If you had open-heart surgery, valve repair, or any bypass procedure in 2024 or 2025, request your full operative report and surgical records. Look for references to the following devices:

• OptiSite Arterial Cannula
• FEM-Flex II Femoral Arterial Cannula

Even if the device is not named directly, an experienced medical product injury attorney can work with specialists to review your records and determine whether a recalled tool was likely used.

Why Prompt Legal Action Matters

New York has a statute of limitations that applies to product liability claims, generally giving injured parties three years from the date of injury, or from when the injury should have been discovered, to file a lawsuit. In cases involving wrongful death, the window may be as short as two years.

Given the complexity of these cases and the time required to gather surgical records, consult experts, and build a claim, it’s important not to wait. If you or your loved one suffered harm, early legal intervention is often key to preserving evidence and protecting your right to compensation.

Contact Parker Waichman LLP For a Free Case Review

If you or a loved one was harmed by a recalled Edwards Lifesciences surgical device, call Parker Waichman LLP at 1-800-YOUR-LAWYER (1-800-968-7529) for a free consultation. Our nationally recognized product liability attorneys are reviewing cases now. Don’t wait, your rights and recovery may depend on timely action. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.