On April 18, 2017, medical device maker Medtronic announced that the U.S. Food and Drug Administration (FDA) has classified the company’s recent field action related to controllers for the HVAD(TM) as a Class 1 recall.
A Class 1 recall is the agency’s most serious recall category. In a Class 1 recall, there is a reasonable probability that the use of or exposure to the product “will cause serious adverse health consequences or death.”
In March 2017, Medtronic began notifying doctors outside the United States about updated HVAD System Controllers and DC Adapters that were developed following two previous Field Safety Notices (April 2015 and April 2016). The FDA approved the updated controller on April 7, 2017, and Medtronic began notifying U.S. practitioners about the updated HVAD Controllers and DC Adapters on April 14, 2017.
HVAD Helps Failing Heart
The HeartWare Ventricular Assist Device (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 patient’s body 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.
In April 2015 and again in April 2016, Medtronic sent notifications to doctors about potential safety issues with the HVAD System Controller. The issues include worn alignment guides, internal “double disconnect (no power) alarm” battery failure, and loose power and data connectors. These issues could lead to possible injury and death, which is why this is a Class 1 recall.
The experienced device injury attorneys at Parker Waichman can provide information and advice to those who have concerns about the HeartWare HVAD device.
According to the FDA, issues with the HVAD controller date back at least to April 2010, when HeartWare said a 2009 redesign intended to waterproof the controllers inadvertently made them airtight and created problems with the controller’s speaker. In February 2015 Medtronic recalled made before made before the FDA approval of the HVAD pump. The April 2015 and April 2016 warnings gave details of issues with the controllers.
Medtronic Updates HVAD Controllers
The updated controllers have design enhancements intended to address the potential safety issues identified in the 2015 and 2016 communicated notices, including:
strengthened power and serial port alignment guides intended to reduce the incidence of wear that could lead to damaged connector pins;
functionality designed to monitor internal battery performance and sound an alert when the internal battery is nearing depletion; and
redesigned connectors and housing intended to prevent the risk of connectors loosening or becoming more vulnerable to damage from exposure to water and other fluids.
In addition, the updated controller introduces upgraded internal circuitry designed to improve overall device reliability.
With the introduction of the updated controller, Medtronic has begun to remove current HVAD Controllers (product codes 1400,1401US and 1407US) in select geographic areas, including the U.S. Medtronic also has begun to remove the related adapters (product code 1435), Instructions for Use, Patient Manuals and Emergency Responder Guides.
Medtronic recommends that HVAD Controllers be exchanged, but the company says doctors should weigh the benefits of the updated controller against the risks of the controller exchange procedure. Before controllers can be exchanged, health care providers must complete training on the updated controller and updated product labeling, including the Instructions for Use and Patient Manual. After completing the training and receiving the updated controllers, physicians are requested to quarantine and replace their patients’ primary and backup HVAD Controllers and DC adapters under clinical supervision and at a hospital where patient support equipment is available. Trained hospital staff must educate patients on using the updated controller.
The company said that it has begun to remove current HVAD controllers, with product codes 1400, 1401US and 1407US in select areas. It also released updated guidelines for clinicians with such devices, advising them to update their training on the newly launched controller.