The FDA announced another Class I recall for HeartWare, this time citing damaged alignment guides or connection pins in its ventricular assist system that potentially could cause the pump to stop. The recall affects 1,763 devices.
According to the FDA, the alignment guides in the power supply connector ports are vulnerable to wear over time. If the pins are twisted or bent, they compromise the connection to the device controller and potentially interrupt power, causing the pump to stop. The ventricular assist system serves as a bridge-to-transplant for patients with end-stage left ventricular heart failure.
HeartWare sent a notice to customers on May 25. On June 8, the Framingham, Mass.-based company posted a letter listing five different complaints it has received for devices with the product codes 1101 and 1103. Under the topic “worn alignment guides,” it instructed customers to inspect the controller’s power supply parts and contact a healthcare provider if they detect damage.
“During the past 18 months, HeartWare has been made aware of worn alignment guides in approximately 1% of distributed controllers,” the company wrote. “HeartWare has initiated a program to improve the strength of the alignment guides in the controller's power supply connector ports to reduce possible damage to the connection pins.”
HeartWare reported 33 malfunctions and one serious injury, according to the FDA.
Customers with damaged alignment guides should schedule an appointment with their providers, who then may recommend a replacement. HeartWare announced that it will replace all defective controllers by June 2016.
HeartWare has issued a series on voluntary notices and recalls over its ventricular assist system and ventricular assist devices, dating back to late 2013.