Device maker HeartWare has issued updated information on the multiple recalls for its Ventricular Assist Device (HVAD).
The recalls were the result of five different types of complaints from users and doctors. The update provides information on proper performance and safe use of the device to prevent the potential patient injuries, according to a company news release.
The HVAD helps deliver blood from the heart to the rest of the body. The device is used in patients with end-stage left ventricular heart failure who are waiting for a heart transplant. The system includes a pump implanted in the space near the heart and a controller that controls the speed and function of the pump.
The recall covers HeartWare Ventricular Assist Devices, product codes 1101 and 1103. The 1,763 recalled pumps were manufactured and distributed from January 2008 to March 2015. The Food and Drug Administration (FDA) has classified this a Class I recall, the most serious category, reserved for situations where there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
In a letter to doctors and patients, HeartWare 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, the device may not give an audible alarm.
- Worn alignment guides. Patients should inspect the controller’s power supply ports for wear or damage to the alignment guides or connection pins. Patients should 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 do not seem to elevate safety risk, but could contribute to the risk of infection at the exit site. Patients should be careful to keep the driveline properly protected under their clothing.
- Driveline pulling and snagging. Patients should avoid accidental snagging or pulling, which could damage or disconnect the driveline. If the driveline is damaged or disconnected, electrical issues or pump stops are possible, and this could lead to serious injury or death. Patients should take care not to catching the driveline on doorknobs, seat belts or vehicle brake handles.
Health care providers with questions should contact their HeartWare representative or HeartWare’s 24-hour Clinical Support at 1-888-494-6365, or email FSCA@heartware.com.
The FDA encourages health care professionals and patients to report adverse events or side effects with the HeartWare system to the MedWatch Safety Information and Adverse Event Reporting Program.
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