08/14/2015 // JusticeNewsFlash // (press release)
Minnesota – Medtronic Plc is reportedly recalling thousands units of a reloading system used in a heart device that was recently approved by the U.S. Food and Drug Administration. Reuters reported that the FDA has categorized the recall as “Class 1” indicating the existence of a reasonable probability that using or being exposed to the product could lead to serious side effects or fatality.
The recall was initiated following reports of the presence of particulates according to the FDA. Medtronic has said that it received 8 reports regarding the potential defect, but there had been no reports regarding “adverse” effects to patients.
The product is the EnVeo R Loading System, which is a component of the CoreValve Evolut R system produced by Medtronic. In the company’s letter to customers it stated that the particulates that may be present in the system have the potential to lead to bloodstream blockage.
There are a reported 540 of the recalled units in the United States.