HeartWare Ventricular Assist System RecallJun 23, 2015
HeartWare initiated multiple recalls for its Ventricular Assist Device (HVAD) because of five different types of complaints received.
The company has issued an update to provide information to reinforce proper performance and safe use of the device to help reduce the potential patient injuries, according to a company news release.
The HVAD helps deliver blood from the heart to the rest of the body and is used in patients who have 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.
The recall covers 1,763 HeartWare Ventricular Assist Devices, product codes 1101 and 1103. The devices were manufactured and distributed from January 2008 to March 2015. This is a Class I recall, the Food and Drug Administration’s most serious recall category, used in situations where there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
In letters to doctors and patients, the company called attention to the following points:
- Maintaining continuous power supply. Patients should never disconnect the pump from both power sources at the same time. If there is a complete interruption of power, and the internal battery is discharged or underpowered, there may not be an audible alarm.
- Worn alignment guides. Patients should inspect their controller's power supply ports for wear or damage to the alignment guides or connection pins. Patients should be careful to avoid twisting or bending the power connection pins. Wear-and-tear to power supply connectors could result in the inability to connect to a power source, possibly resulting in an interruption in electrical connectivity, which could lead to a pump stop. Pump stops could cause death or serious injury.
- Power management software upgrades. Temporary loss of communication between the controller and the batteries can result in premature "battery switching" or false battery alarms. These alarms do not increase risk to patients, but may result the need for more frequent battery changes. HeartWare is developing a software upgrade to improve how the controller manages a transient loss of communication between the controller and HVAD system batteries.
- Driveline outer sheath discoloration and cracking. Patients should be aware that the driveline outer sheath may become discolored or display small cracks over time. This outer, protective covering contains a plastic material that may degrade if exposed to excessive ultraviolet light. Discolored or cracked outer sheaths have not demonstrated an elevated safety risk, but could contribute to the risk of infection at the exit site. The notice reminds patients to keep their driveline properly protected under their clothing.
- Driveline pulling and snagging. Patients should take care to avoid accidental snagging or pulling, which could damage the driveline or disconnect it. If the driveline is damaged or disconnected from the controller, electrical issues or pump stops are possible, which could lead to serious injury or death. Patients should avoid catching the driveline on doorknobs, seat belts or vehicle brake handles.
Health care providers who have questions should contact their HeartWare representative or HeartWare’s 24-hour Clinical Support at 1-888-494-6365, or email FSCA@heartware.com.
Health care professionals and patients are encouraged to report adverse events or side effects with the HeartWare system to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: www.fda.gov/MedWatch/report.