FDA designates Class I recall for arterial cannulae due to exposed wire risk

Editor's Note

The US Food and Drug Administration (FDA) has designated a Class I recall—the most severe category indicating risk of serious injury or death—for several models of arterial cannulae manufactured by Edwards Lifesciences. Affected products include OptiSite Arterial Perfusion Cannula models OPTI16 and OPTI18, as well as Peripheral Femoral Arterial Cannula models FEMII016A, FEMII016AS, FEMII018A, and FEMII018AS.

The recall was issued after Edwards identified instances in which a 3mm to 4mm section of wire from the reinforcement coil at the cannula tip became exposed. Risks to patients include major tissue damage, arterial puncture, inadequate perfusion, and hemolysis. As of May 20, 2025, no serious injuries or deaths have been reported.

Customers are instructed to immediately remove affected products from inventory, notify relevant clinical staff, and coordinate returns through a company representative. Distributors are instructed to notify all customers who purchased the affected devices. Full details and contact information are available in the complete FDA announcement.