FDA Issues Class I Recall for Edwards Lifesciences’ Arterial Cannulas Over Exposed Wire Risk

The FDA has announced a Class I recall of Edwards Lifesciences’ arterial cannulas after reports of exposed wires that could lead to arterial puncture, bleeding, hemolysis, or inadequate perfusion during cardiopulmonary bypass procedures.

The recall affects over 27,000 Optisite Arterial Perfusion cannulas and several models of peripheral femoral cannulas that share similar components. Although no serious injuries or deaths were reported as of May 20, exposed 3–4mm wire segments raised serious safety concerns.

Edwards confirmed a few cases of wire protrusion prior to use in surgery and sent notices to customers in May, urging them to return affected devices for credit.

The FDA emphasized that the protruding wire coil at the cannula tip could cause significant tissue damage. Edwards' financial results, released the same day, showed a 12% sales increase, prompting an upward revision of its annual revenue forecast.

31-07-2025