By Richie Crider
Medtronic (NYSE: MDT) (Dublin) has initiated a Class I global recall of its EnVeo R loading systems, a component of its recently approved self-expanding CoreValve Evolut R system, citing concern over a particulate in the system that may be transferred to the transcatheter aortic valve (TAV).
FDA approved the Evolut R in June for TAV replacement in severe aortic stenosis patients who are at high or extreme risk for surgery. However, in a July 2015 letter to consumers, Medtronic said the particulate may release into the patient's vasculature upon deployment of the TAV, causing harm such as a blockage in the bloodstream. So far, Medtronic has received eight reports related to this issue out of 7,347 potentially affected units. In two of the incidents, users spotted the particulate in the packaged kits, and in the remaining six incidents users observed the particulate in the loading bath during valve loading.
However, Medtronic said in the letter, they have not receive any reports of patient injury related to the presence of the particulate. The company added that the recall does not affect other Medtronic devices or other components of the Evolut R TAV system.
In the official recall notice on the FDA's website, the agency said the recall includes 6,912 units, 540 of which were distributed in the U.S. The remaining units were distributed in countries such as the Dominican Republic, Greece, and New Zealand.
All affected systems have been withdrawn from the market, Medtronic spokeswoman Wendy Dougherty told Reuters, adding that no affected loading systems had been released commercially in the U.S.
In its letter to consumers, Medtronic instructed users to immediately quarantine any unused products and return all potentially affected units.