Recall Alert: Edwards Lifesciences Arterial Cannulae

Edwards Lifesciences Recalls Arterial Cannulae Over Risk of Exposed Wire

Edwards Lifesciences has issued a Class I recall of certain arterial cannula devices due to the risk of wire exposure near the cannula tip, which could lead to serious injury or death if used.

Product Use

The recalled arterial cannulae are used in adult cardiopulmonary bypass procedures, delivering oxygenated blood from the extracorporeal circuit into the patient’s artery for up to six hours.

Why This Matters

The company discovered that a 3–4 mm segment of internal wire from the reinforcement coil can become exposed at the cannula tip. This defect may occur in both the OptiSite Arterial Perfusion Cannula and Femoral Arterial Cannula models, which share the same component materials.

Potential patient risks include:

• Major tissue damage
• Arterial puncture and bleeding
• Inadequate blood perfusion
• Hemolysis (destruction of red blood cells)

No injuries or deaths have been reported as of May 20, 2025.

Affected Products

 What To Do

On May 16, 2025, Edwards Lifesciences began notifying customers via Field Corrective Action #192, advising the following:

• Stop using and remove any affected products from inventory
• Notify all relevant clinical staff at your facility
• No patient follow-up is required
• Work with your Edwards eCV representative to return affected products and receive a credit
• Distributors must notify their customers with the recall letter

Contact Information

If you have questions or need to report quality issues or adverse events, contact:

• Email: FCA_ECV@edwards.com
• Phone: 888-943-2783

Read the FDA recall announcement here.