Flaws with a heart device that Medtronic Plc bought last month as part of a $1 billion deal have been deemed potentially life-threatening by U.S. regulators.
The device, called the HVAD System, takes over for a failing heart. One patient may have died because of a flaw where moisture can penetrate the mechanical pump through loose power or data connectors, said Chris Garland, a spokesman for the company. Medtronic acquired the device with its purchase last month of HeartWare International.
Doctors and patients were first notified about the issue in May and June, with instructions to closely monitor the HVAD System for loose connections, the company said in a statement Friday. The U.S. Food and Drug Administration has since classified the issue a Class 1 recall, meaning the problem is potentially life-threatening. Recall designations are used to classify an issue’s severity, and doesn’t mean that the devices necessarily need to be removed from patients and replaced.