|HeartWare's Ventricular Assist System--courtesy of HeartWare|
HeartWare ($HTWR) has been hit by its third Class 1 recall since April 2014, all involving its flagship bridge to heart transplantation pump, the Ventricular Assist System.
In a recall notice posted in its recall database on May 14, the FDA 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.
As a result, 35 units of the splice kit in 6 states, Canada and Europe are under a Class 1 recall, the most urgent kind, meaning the FDA believes there is a reasonable probability that the device "will cause serious adverse health consequences or death."
HeartWare sent affected customers a correction letter on May 11. It urged the recipient to "identify patients that are currently on support and have undergone a driveline splice repair, distribute the Patient Communication to the affected patients in person, and continue to reinforce the messages described in the notice with patients who have experienced a splice repair during their regularly scheduled appointments."
The Ventricular Assist System consists of a surgically inserted pump, a controller, and adapters and wires that connect to and power the pump via an electrical socket or battery for mobile use. The patient wears the various external parts on a belt around the waist.
HeartWare's glossary says the driveline is the cable attached to the implanted pump that passes through the skin to connect to the controller. The recall notice specifies that the splice kit is only used to repair electrical breaks that occur outside the patient boundary.
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 numerous safety scares could be a deterrent.
In February, the FDA revealed the system was under a voluntary recall, deemed Class 1, because of the controller's higher susceptibility to electrostatic discharge than some newer, commercial ones. And in April 2014, HeartWare was hit by another Class 1 recall, its first since the pump was approved in 2012.
Shortly thereafter, the company issued a voluntary correction notice about earlier-than-expected battery depletion and routine battery handling in the Ventricular Assist System due to a spike in customer complaints.
But that didn't stop the FDA from issuing a warning letter as a result of its January inspection of HeartWare's Miami Lakes, FL, operations, management and manufacturing facility.
Rival Thoratec 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.
- read the FDA's recall notice