Defective Heart Pump Forces Recall from Medical Device Company
A defective heart device is forcing a recall from one of the largest medical device manufacturers in the world.
Medtronic PLC has recalled almost 7,000 devices after reports of the presence of particulate matter, according to Reuters. The Irish company said that it has received eight reports related to the issue, but no adverse patient effects.
The recalled product is the EnVeo R Loading System, which was cleared for marketing in the United States in June. The device is designed for use in patients who suffer from aortic stenosis and for whom surgery is too risky. Particulates can be dangerous as the matter can coagulate and cause blockages in the bloodstream.
The U.S. Food and Drug Administration (FDA) classified the recall as "Class 1", which indicates that using the product could cause serious side-effects or death. The product was marketed in several countries in North America, Europe, and Asia.
Both the company and agency agree that the issue stems from improper manufacturing processes, an issue which has since been resolved.
For a full list of the specific product codes being recalled, see the FDA press release. Customers with questions should contact Lauralie Millikan at (763) 514-9605.