FDA declares Class I recall on heart surgery procedure kits from Medline

The U.S. Food and Drug Administration (FDA) has announced an expansion of an earlier Medtronic recall, now issuing a new Class 1 recall for Medline Industries' procedure kits that contain Medtronic aortic root cannulas. The recalls indicate that there may be excess material in the male luer, which could potentially lead to serious adverse events, including procedure delays, neurological deficits, strokes, or even death.

Medtronic initially announced a recall on February 5 and sent all affected customers an urgent medical device recall letter, recommending hospitals monitor patients who were previously supported by this device and identify and quarantine all unused affected products. The FDA enforcement report stated that this recall included 316,205 devices, distributed both in the U.S. and in numerous other countries.

This was followed by another recall on February 21, when Medline Industries sent all affected customers an "immediate action required" recall notice because Medtronic's aortic root cannulas are included in their bypass surgical procedure kits. The Medline recall included 3,345 devices.

Medline is providing a sticker to be attached to the procedure kits, notifying users not to use the cannula within the procedure kit and to instead use one from another supplier, the FDA said.

The FDA also stated that, as of now, there have been no reported injuries or deaths.

Aortic root cannulas are used for six hours or less during surgery with a heart-and-lung machine for cardiopulmonary bypass. The device may also be used to remove air from the aorta once a bypass procedure is finished.