Medtronic recalls loading system for heart device

The U.S. Food and Drug Administration classified the recall as "Class 1", implying there is a reasonable probability that the use of or exposure to the product could cause serious side-effects or death. (1.usa.gov/1McR6cs)

The product, EnVeo R Loading System, is part of Medtronic's CoreValve Evolut R system, which was cleared for marketing in the United States in June.

The Evolut device is approved for transaortic valve replacement (TAVR) in patients with severe aortic stenosis — a condition where the aortic valve narrows — and for whom surgery is too risky.

The presence of particulates could potentially lead to the introduction of a blockage in the bloodstream, Medtronic said in a letter to customers.

The issue has been resolved with improvements in the manufacturing process, Dougherty said.

Medtronic, founded in 1949 is a world-wide leading device maker with speciality in cardiac rhythm disease management, spinal and biologics, cardiovascular, neuromodulation, surgery, diabetes, etc