Federal health regulators have recategorized a voluntary field action involving controllers and DC adaptors for the Medtronic HeartWare Ventricular Assist Device (HVAD) System as a class I medical device recall, since the variety of mechanical errors associated with the product could result in severe patient injury or death.
The Medtronic HVAD System Controllers recall was announced by the FDA last month, due to the potential for the device to experience battery failure, power and data failures, and premature waring of the alignment guides that could prevent treatment.
The Medtronic HVAD is used as a bridge device on patients suffering from advanced heart failure, while they await cardiac transplantation. It is used during emergency medical flights on airplanes and helicopters, as well as in hospitals, to keep patients alive until a heart transplant can be performed.
Medtronic first learned of the potential problems with certain HVAD System Controllers and DC Adapters after receiving two Field Safety Notices in April 2015 and April 2016. According to the field complaints, Medtronic learned that the use of the devices could lead to possible injury or death due to worn alignments guides, internal “double disconnect alarms cutting the power, and total loss of power and data.”
Prior to the initial recall, the FDA issued a warning letter to Medtronic’s subsidiary company HeartWare in January 2014, after receiving 27 field reports, including two fatalities and at least four serious injuries resulting from mechanical errors associated with the devices. In the warning letter, FDA investigators cited a number of deficiencies at the HeartWare Miami Lakes, Florida, facility that included the functioning of the HVAD device.
Specifically, the FDA warning letter accused the company of failing to establish and maintain procedures for validating the device’s design, particularly the design of the controller; failing to implement corrective and preventative actions after receiving numerous complaints; failing to maintain records of the investigation into problems with the HVAD; and failing to validate computer software used as part of its quality control system.
In April 2015 and April 2016, Medtronic began notifying clinicians of the potential safety defects and updated consumers that a new version of the controller would be available once designed and tested.
On April 7, 2017, Medtronic received approval for the new and updated design of the new HVAD System Controllers and DC Adapters from the FDA and began notifying clinicians outside of the United States in early March. The updated controllers include enhancements to address potential safety issues, strengthen power and serial port alignments, monitor internal battery performance and prevent connectors loosening events.
The FDA categorized Medtronic’s voluntary field action to a Class I recall following the introduction of the new product to alert clinicians that the recalled devices will be removed in select geographies, including the United States. The recall indicates Medtronic has also begun removing the related adapters.
Medtronic is recommending all clinicians notify their patients of the recommended exchange and to weigh the benefits of the updated controller against the risk of a controller exchange procedure that could be more harmful to patients. Clinicians will be provided with updated instructions for the devices and will receive mandatory training, including new instructions for Use and Patient Manual.