FDA Notice: Medtronic Recalls Aortic Root Cannulas Due to Safety Concerns

According to a March 31 notice from the FDA, Medtronic has issued a recall for certain Aortic Root Cannulas due to the potential presence of unexpected loose material in the male luer, which could dislodge during use, leading to serious health risks such as stroke, delayed therapy, and even death.

The recall involves specific product lots of the DLP Aortic Root Cannula, MiAR Cannula, and DLP Aortic Root Cannula with Vent Line.

Healthcare providers are advised to monitor patients previously treated with these devices, as there is no immediate risk to those already treated. Affected products should not be used, and unused devices from the recall lots must be returned.

Medtronic has notified affected customers and provided instructions for the return process. No injuries or deaths have been reported from the issue.