The HeartWare Ventricular Assist Device (HVAD) has been the subject of a series of recalls. All HeartWare systems currently in use are being recalled. Recalled systems were manufactured and distributed between January 2008 and March 2015. HeartWare will replace all defective controllers by the end of June 2016.
The HVAD 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 and a controller that controls the speed and function of the pump.
HeartWare International, Inc. issued a voluntary Urgent Medical Device Correction on May 11, 2015, describing five different types of complaints reviewed as part of HeartWare's ongoing product performance monitoring. The notice provides information to reinforce proper performance and safe use of the HeartWare Ventricular Assist System to help reduce the potential occurrence of avoidable patient injury. In letters to clinicians and patients, the company reminds patients with HeartWare System product codes 1101 and 1103 to follow directions in the Patient Manual and to be aware of certain signs of wear. Specifically, the notice calls attention to maintaining continuous power supply, worn alignment guides, power management software upgrades, driveline outer sheath discoloration and cracking, and driveline pulling and snagging.
In June three issues were added as part of HeartWare's ongoing product performance monitoring.
- Damaged Alignment Guides/Connection Pins May Cause Pump to Stop: The alignment guides in the power supply connector ports may wear down over time. This can cause the connection pins to become twisted or bent, and eventually prevent the patient from connecting the device controller to their HVAD. An interruption in this electrical connection would cause the pump to stop, which could cause serious patient injury or death. The company has reported 33 reports of malfunction and one serious injury related to this problem.
- Battery Failure May Prevent Alarm from Sounding: The battery that powers an alarm in the controller may fail over time. If the battery fails, the alarm will not alert the patient in the event that both external power sources for the HVAD are disconnected. The HVAD should never be disconnected from both power sources at the same time because the pump will stop working. If a pump stop occurs, the potential risk for the patient ranges from minimal temporary symptoms of hypoperfusion to cardiopulmonary arrest and death. The firm has received a total of four reports of incidents in which the device has malfunctioned, including three injuries and one death.
- Damage to Driveline Connector May Cause Electrical Issues or Pump Stops: Damage to the driveline connector may occur if the driveline is pulled too often with too much force. The driveline is a tube that connects the HVAD’s pump to the external controller and power source. Severe damage or disconnection of the driveline from the controller can cause electrical issues or pump stops that may lead to serious patient injury or death. The firm has received a total of three reports, including one serious injury and two reports of death related to damage to this issue.
The FDA has classified this 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.
See the Recall
See also Medical Law Perspectives, July 2015 Report: Transplant Liability Risks (to be published July 7, 2015)
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