Edwards Lifesciences has recalled over 61,000 units of its OptiSite Arterial Cannula and FEM-Flex II Femoral Arterial Cannula due to a potential safety hazard, according to the FDA. These devices, used in cardiopulmonary bypass and cardiac surgeries, may have a 3–4 mm wire segment that can become exposed during use, risking serious tissue damage.
The FDA classified all six recalls as Class I, indicating possible serious adverse health outcomes or death. Edwards Lifesciences reported no injuries to date and identified the defect during routine quality inspections before procedures. Customers were immediately notified and instructed to return affected devices.
The recalled devices were distributed globally, and clinical staff should be informed of the issue. No patient follow-up is currently required. Edwards continues to investigate the root cause of the defect.
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