Medtronic has issued a Class 1 recall of its EnVeo R loading system following eight reports of the presence of particulates, which could potentially lead to blockages in the bloodstream.
The company recalled 6,912 units of the device from the market, while assuring that no affected loading systems had been released commercially in the USA.
The EnVeo R loading system is part of Medtronic’s CoreValve Evolut R system, which was cleared for marketing in the USA in June. The Evolut device is approved for transaortic valve replacement in patients with severe aortic stenosis.
Medtronic says that improvements to the device’s manufacturing process have now resolved the issue with the device.