|The pump component of the HeartWare Ventricular Assist System--Courtesy of HeartWare|
HeartWare ($HTWR) has issued a voluntary recall of some of its Ventricular Assist System Controllers due to their higher susceptibility to electrostatic discharge than some newer, commercial controllers. An electrostatic discharge can cause a pump to stop, which could result in serious injury or death.
The recall is specifically for HeartWare controllers with product codes 1400 and 1401XX. These were distributed during the ADVANCE and ENDURANCE clinical trials prior to FDA approval in 2012. The devices have serial numbers CON000001 through CON005472.
This is just the latest compliance problem for the company. This recall is an expansion of a prior 2013 recall and is expected to impact about 120 patients in the U.S. Since the earlier notice, the company said that the system had caused one additional death and one additional serious injury in which electrostatic discharge may have caused a pump to stop.
In April 2014, it also had two corrective actions: one due to a driveline connector problem in all the devices distributed to clinical sites in December 2013 that could cause a temporary pump stop and the other due to earlier-than-expected battery depletion in some of its ventricular assist systems. At Sept. 30, HeartWare estimated that it had $2.6 million in recall-related costs.
The company advises that patients can reduce the risk of electrostatic discharge by avoiding activities and fabrics that generate static electricity. Patients are advised to contact their physicians to arrange a risk assessment and a possible exchange of the implantable device.
The FDA approved the Ventricular Assist System in November 2012 as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The device also has the European CE mark.
HeartWare shares remained largely unchanged in response to the latest news. But in the last year, the share price for the $1.5 billion company has deteriorated by 11%.
- here is the release
- and the FDA documentation on the original recall from April 2013