FDA: Class I recall of Medtronic HVAD controllers, DC adapters

Editor's Note

The Food and Drug Administration (FDA) on April 18 designated the recall by Medtronic of its HVAD (HeartWare [left] ventricular assist device) system controllers and DC adapters as Class I, the most serious.

Medtronic is issuing an updated controller and has begun to remove current HVAD controllers. The company has also begun to remove the related adapters, instructions for use, patient manuals, and emergency responder guides.

Safety issues with the current HVAD controller include, that it could lead to possible injury and death because of worn alignment guides, internal double disconnect alarm battery failures, and loose power and data connectors.

Medtronic plc (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has classified the company's recently initiated voluntary field action related to its HVAD(TM) System Controllers (serial numbers lower than CON300000) and DC Adapters (all serial numbers for product code 1435) as a Class I recall.