The HeartWare VAS, distributed by HeartWare of Miami Lakes, FL, has been recalled. 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. If the pump stops working, it can lead to serious adverse health consequences, including death.
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 has received additional reports of electrostatic discharge that may have contributed to patient injury or death. The FDA determined the cause of the problem is the device design.
The HeartWare VAS 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 affected products have device model numbers 1400 and1401XX. These were distributed from March 2006 to February 2014.
On February 20, 2015, HeartWare sent an "Urgent Medical Device Recall" letter to their customers. Heath care providers were to identify patients with the affected device and review the risks of electrostatic discharge with patients including avoiding dry environments, certain materials, electronic devices prone to static electricity, and activities such as vacuuming and removing clothes from a dryer. Providers were to exchange the recalled controller for a new controller, if medically advisable. The exchange should take place in a controlled setting under medical supervision. Controllers should be exchanged for a new controller with a serial number of CON005473 or higher.
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, 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