FDA Warns Risk of Death and Injury with Recalled HeartWare Heart Implants

Santa Clara, CAThe US Food and Drug Administration (FDA) has updated information concerning a Class 1 Recall for a total of 4,669 HeartWare Ventricular Assist Devices (HVAD), made by Medtronic. An FDA Class 1 recall is the most serious type of recall the agency issues, because the allegedly defective product poses “a reasonable probability that use of these products will cause serious adverse health consequences or death.”

Designed for use both in and out of hospital settings, including during patient transport, the HVAD helps deliver blood from the heart to the rest of the body. It is used in patients who are at risk of death from end-stage left ventricular heart failure and who are waiting for a heart transplant. The system includes a pump implanted in the space around the heart (pericardium) and a controller that controls the speed and function of the pump.

On June 8, 2016, HeartWare Inc. sent an “Urgent Medical Device Correction” letter to affected customers. However, Medtronic is recalling the HVAD controller due to a loose power connector which may cause the rear portion of the pump’s driveline connector to become separated from the front portion of the driveline connector.

A loose connector may allow moisture to enter the controller causing corrosion, electrical issues, reduced speaker volume and connection failures. If the speaker volume is decreased, the patient may not hear the alarm. If there is a loss of connection, the pump may stop which could cause serious adverse health effects including death.

The affected devices were manufactured between September 30, 2014 and February 29, 2016. A total of 4,564 units were identified in the FDA’s recall notice.

The FDA recall identifies the affected HeartWare controllers with product codes 1403, 1407,1400 and 1401.
The company said it notified patients with devices on June 8, instructing them about safe use of the device and to inspect for loose connectors.