Medtronic has announced that the U.S. Food and Drug Administration (FDA) has classified two global voluntary recalls of HeartWare International’s HeartWare Ventricular Assist Device (HVAD) as Class 1 recalls.
A class 1 recall is the FDA’s most serious recall category, reserved for situations where there is a reasonable risk of serious adverse health consequences or death.
The HVAD helps deliver blood from the heart to the rest of the body. A ventricular assist device 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 HVAD system includes a pump that is implanted in the space around the heart (pericardium) and a controller to regulate the speed and function of the pump.
The HVAD is intended for use both in and outside a hospital setting, including during patient transport.
The recall is being undertaken because of a design problem with driveline connectors that connect the HVAD’s pump to the external controller and power source. The design flaw with the driveline connector may cause fluid or other material to enter the pump and cause electrical issues or pump stoppage, according to the FDA.
A company news release explains that the recall came in two parts. In a safety notification letter sent in May and June 2016, HeartWare notified doctors of regarding potential damage to controllers from exposure to moisture through loose power and data connectors. The controllers were model numbers 1400 and 1401. In the U.S., all clinician notifications have been acknowledged, and globally 99 percent of clinician notifications have been acknowledged, according to the news release.
In August 2016, HeartWare recalled some unimplanted HVAD Pump Implant Kits in hospital inventories. The HVAD pumps in these implant kits may be susceptible to electrical faults and connection failures if fluid enters the driveline-to-controller connector during or after the implant procedure. Electrical faults or connection failures could interrupt circulatory support due to a pump stop, potentially resulting in serious injury or death. In the U.S., all clinician notifications have been acknowledged, and globally 89 percent of clinician notifications have been acknowledged.
HeartWare instructed affected customers to identify the pumps in inventory and return them, as well as reminding patients with HVAD systems of safe use procedures with the devices.
All HVAD with product codes 1103 and 1104 and serial numbers lower than HW25838 are included in the recall. These devices were manufactured between March 17, 2006 and June 27, 2016.
Health care providers with questions about the recall were advised to contact their HeartWare representative or contact HeartWare Inc. at email@example.com or 1-877-367-4823.