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| HeartWare's Ventricular Assist System--Courtesy of HeartWare |
HeartWare ($HTWR) sent clinicians and patients a voluntary "urgent medical device correction" about the proper use and potential problems associated with its flagship bridge to heart transplantation device. The company has been hit by three Class 1 recalls of the Ventricular Assist System since April 2014, meaning the agency believes there is a reasonable probability that the device "will cause serious adverse health consequences or death."
Besides mechanical problems, artificial ventricular assist devices have 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), or being tethered to a power outlet that connects to an electrical socket.
According to a company release, the May notice reminds people to never disconnect the HVAD Pump from both power sources at the same time. "Like all batteries, this battery may degrade with age. If there is a complete interruption of power (i.e., a 'double disconnect') and the internal battery is discharged or underpowered, there may not be an audible alarm," the release says.
HeartWare also instructs patients to avoid accidental snagging or pulling of the driveline, which could cause disconnection or damage to the component. The driveline is the cable attached to the implanted pump that passes through the skin to connect to the controller.
The letter to patients and clinicians also warns of worn alignment guides, according to the release: "The notice instructs patients to inspect their controller's power supply ports for potential wear or damage to the alignment guides or connection pins. If damage is found, patients should use care when connecting power sources to avoid twisting or bending the power connection pins, and should contact their healthcare provider to schedule an appointment and possibly arrange for a replacement controller."
Another problem is false battery alarms. HeartWare expects to roll out a software upgrade that corrects the problem later this year, the release says.
In addition, HeartWare says, "the notice reminds patients to keep their driveline protected under their clothing as described in the Patient Manual. HeartWare introduced a thicker sheath in 2013 internationally and 2014 in the U.S. that has generated fewer complaints related to discoloration and cracking than the thinner sheath. "
The most recent HeartWare Class 1 recall occurred in May. In a recall notice posted in its recall database, 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.
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.
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 release