|The HeartWare controller that is being replaced because of problems with the power supply connector ports--Courtesy of HeartWare|
HeartWare ($HTWR) will replace the defective controllers of its artificial blood pumps, marking its fifth corrective action of the year deemed a Class 1 recall by the FDA. Class 1 recalls are reserved for situations in which the agency believes there is a reasonable probability that use of or exposure to the device "will cause serious adverse health consequences or death."
In a June 16 safety alert, the FDA said that Ventricular Assist System's "alignment guides in the power supply connector ports may wear down over time. This can cause the connection pins to become twisted or bent, and eventually prevent the patient from connecting the device controller to their VAS (Ventricular Assist System). An interruption in this electrical connection would cause the pump to stop, which could cause serious patient injury or death."
There have been 33 reported instances of this problem, which has resulted in one serious injury, the alert says.
HeartWare sent its customers a correction notice on May 25 to alert them of the problem. According to the FDA, the company urged hospitals to "Make appointments to see the patients subject to this recall as soon as possible, and inspect their device's power supply connector ports for wear, twisting, or bending. Consider replacing the controller if necessary."
In the safety notice, the FDA is more definitive than was the May correction notice. The agency states that "HeartWare will replace all defective controllers by the end of June 2016." The alert covers all 3,747 HeartWare systems currently in use.
The company's Ventricular Assist System is meant to serve as a bridge to transplantation for patients awaiting a heart transplant by pumping blood around the body, but has been plagued by a slew of safety issues so far in 2015.
|HeartWare's Ventricular Assist System--Courtesy of HeartWare|
In a Class 1 recall notice posted on the FDA's database in May, the agency warned that the device's splice kit, used to repair electrical breaks in the external part of the pump's driveline cable, can fail if exposed to excessive force.
HeartWare also earned a Class 1 recall in June by sending a voluntary letter to customers explaining how to safely use the device, and potential problems associated with it, including false battery alarms and accidental snagging or pulling of the driveline, which could cause disconnection or damage to the component.
Besides mechanical problems, the Ventricular Assist System has some usability issues--though that it isn't too surprising given the inherent challenges of wearing critical components of a blood pump around the waist (such as batteries), walking around with a wire underneath your shirt that connects to the implanted pump, or being tethered to a power outlet that connects to an electrical socket (when the batteries are not in use).
HeartWare seeks an expanded indication of the device from the FDA that would allow the system to be used as a long-term "destination therapy" for patients who are ineligible for a heart transplant, but the numerous safety scares could be a deterrent.
Rival Thoratec ($THOR) already has the coveted destination therapy designation from the FDA.
But in March 2014, the company was hit with four separate Class 1 recalls of its own after four patients on its HeartMate II pump died after struggling to switch to backup system controllers when their external battery pack ran low on power. It had four voluntary corrective actions deemed a Class 1 recall by the FDA last year, but none this year, compared to 5 for HeartWare.
The company's stock is essentially unchanged since news of the controller issue was first publicized in the recall database on June 13, indicating the financial impact of the news is likely quite small. In an SEC filing, HeartWare said it incurred recall-related costs of $1.3 million in Q1 2015.