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# Edwards Lifesciences Recalls Optisite Arterial Cannula
- URL: https://www.fdaweb.com/edwards-lifesciences-recalls-optisite-arterial-cannula/
- Published: 2025-07-14T12:00:00.000Z
- Updated: 2026-09-14T15:16:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159500

Edwards Lifesciences has recalled (Class 1) its Optisite Arterial Cannula due to complaints received about its 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. The company says the device provides or establishes arterial perfusion in the extracorporeal circuit.

The company recently sent a recall letter to customers “informing them that Edwards has confirmed a small number of occurrences impacting the OptiSite Arterial Perfusion cannula in which a 3mm to 4mm section of wire, from the wire-reinforcement coil at the cannula tip, was found to be released from the cannula body,” a recall notice says. The risk for the wire-reinforcement coil protruding out of the cannula body is major tissue damage and hemolysis, it says.