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# Edwards Lifesciences Recalls Arterial Perfusion Devices
- URL: https://www.fdaweb.com/edwards-lifesciences-recalls-arterial-perfusion-devices/
- Published: 2025-07-25T12:00:00.000Z
- Updated: 2026-09-14T15:17:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159574

Edwards Lifesciences has recalled (Class 1) its OptiSite Arterial Perfusion Cannula and Peripheral Femoral Arterial Cannula after receiving reports in which a 3mm to 4mm section of wire, from the wire-reinforcement coil at the cannula tip, was found to be exposed (released from the cannula body). “Since some Femoral Arterial Cannula models are made of the same components as the impacted OptiSite Arterial Perfusion Cannula, Edwards has included those Femoral Arterial Cannula models as affected product to be removed from use,” a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/arterial-cannula-recall-edwards-lifesciences-removes-arterial-cannula-due-risk-wire-exposure?ref=fdaweb.com) says. “Risks to the patient of using the affected product with exposed wire include major tissue damage, puncturing the artery which could cause bleeding, inadequate perfusion, and hemolysis.”

The devices are indicated for adult patients undergoing cardiopulmonary bypass, and they are intended to provide arterial perfusion of oxygenated blood in the extracorporeal circuit for up to six hours, according to the notice.