FDA issues Class 1 recall for vascular cannulas

Editor's Note

Aortic root cannulas from Medtronic are the subject of the latest US Food and Drug Administration (FDA) class 1 recall, the most serious category reserved for risk of injury or death.

Affected products include the DLP Aortic Root Cannula, MiAR Cannula, and DLP Aortic Root Cannula with Vent Line. FDA’s March 31 announcement advises providers are advised to quarantine all unused product, contact the company, and monitor patients previously treated with the devices.

As detailed in the full announcement, the recall was motivated by the risk of loose material in the male luer resulting in delayed therapy, stroke, and death. No injuries or deaths have been reported.