On June 29, 2016, the FDA classified the HeartWare Ventricular Assist Device (HVAD) recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
The HeartWare HVAD, manufactured by HeartWare International, Inc., of Framingham, MA, helps deliver blood from the heart to the rest of the body. It is used in patients who are at risk of death from 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.
This recall includes the batteries used on the HeartWare Ventricular Assist Device (HVAD) Model number 1650 with serial numbers BAT000001 to BAT199999. The affected HVADs were manufactured between May 19, 2013, and July 1, 2015, and distributed between May 21, 2013, and July 31, 2015. A total of 18,631 units have been recalled nationwide.
The HeartWare HVAD was also recalled on February 2, 2015. At that time the FDA warned that a buildup of static may cause a sudden discharge of electricity (electrostatic discharge) in the device. When this happens, data in the motor controller that manages the pump’s operation may be corrupted and the device may stop working. HeartWare first became aware of this issue in May 2013. At that time they sent a "Field Safety Corrective Action Notice" to their customers to alert them of the problem. Since 2013, HeartWare received additional reports of electrostatic discharges that may have contributed to patient injury or death.
Additionally, on May 11, 2015, HeartWare International, Inc., of Framingham, MA, issued a voluntary Urgent Medical Device Correction describing five different types of reports reviewed as part of HeartWare's ongoing product monitoring: failure of the double disconnect alarm, worn alignment guides, loss of communication between the controller and batteries, discoloration and cracking of the driveline outer sheath, and driveline pulling and snagging.
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 notice reminded patients never to disconnect the HVAD Pump from both power sources at the same time. The HVAD controller has an internal battery with the sole purpose of powering a "double disconnect alarm" in the unlikely event that both power sources are simultaneously disconnected. Like all batteries, this battery may degrade with age. The internal battery is the final mitigation in a cascade of power management risk controls, which include labeling, patient training and alarms related to external battery charge. A failure of the internal controller battery has no impact on normal functionality of the controller and is unlikely to have a clinical impact, provided patients follow the Patient Manual and never disconnect from both power sources at the same time.
The alignment guides in the controller's power supply connector ports may wear down over time. The notice instructed 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. Over time, substantial wear-and-tear to power supply connectors could result in the inability to connect to a power source, potentially resulting in an interruption in electrical connectivity, which could lead to a pump stop. Pump stops could cause death or serious injury. Over an 18-month period, HeartWare was made aware of worn alignment guides in approximately one percent of distributed controllers.
In certain situations, it is possible that a temporary loss of communication between the controller and the batteries can result in premature "battery switching" or false battery alarms. Unnecessary battery switching and false battery alarms do not increase the risk to patients, but may result in an increase in alarms or 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. In the meantime, the notice reminded patients to always treat battery alarms in accordance with the instructions in the Patient Manual.
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 (UV) light, such as from direct sunlight or tanning beds, while the internal driveline conductors remain protected and intact. 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 reminded patients to keep their driveline protected under their clothing as described in the Patient Manual.
Patients should take care when managing their drivelines to avoid accidental snagging or pulling, which could cause damage to the driveline or a disconnection. If a driveline is severely damaged or disconnected from the controller, electrical issues or pump stops are possible, which could lead to serious injury or death. Patients are reminded to follow the instructions in the Patient Manual and not to pull, kink, or twist their drivelines. For example, the notice reminded patients to avoid catching their driveline on hazards such as door knobs, seat belts, or vehicle brake handles.
See the FDA Safety Alert
Also see the Recall
See also Medical Law Perspectives, July 2015 Report: Organ Transplants: Saving Lives, Facing Risks, Minimizing Complications
See also Medical Law Perspectives, February 2015 Report: Mending a Broken Heart: Malpractice Risks in Diagnosing and Treating Heart Disease
See also Medical Law Perspectives, February 2014 Report: Congenital Heart Conditions: How Infants, Adults, and Healthcare Providers Handle the Risks
See also Medical Law Perspectives, November 2013 Report: Diagnosis and Treatment of Heart Attacks: Liability Issues