Medtronic has just issued a voluntary field action recall for its HVAD (HeartWare Ventricular Assist Device) heart pump system. It has been classified as a Class 1 recall by the U.S. Food and Drug Administration (FDA) and is the most serious designation assigned by the FDA. Class 1 recall is used when there is a reasonable probability that product use could cause serious adverse health consequences or death, reports MassDevice Today.
The recall involves issues with worn alignment guides, internal battery failures, and loose power and data connectors, according to Medtronic. All of the issues may lead to possible injury and death, the manufacturer said.
Medtronic purchased the HVAD system device in August 2016 as part of a $1 billion deal involving purchase of HeartWare International, according to Bloomberg.com.
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What is the HVAD System?
The HVAD heart pump system takes over heart function in the event of a failing heart. The ventricular assist device is used in patients who are at risk of death from end-stage left ventricular heart failure and who may be 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.
System controllers with serial numbers lower than CON300000 and DC adapters with all serial numbers for product code 1435, were identified in the recall, MassDevice Today reports.
Medtronic corrected issues related to the recall and received FDA approval on April 7. The company began notifying users of the updated device seven days later. The new controller has strengthened power and serial port alignment guides, new internal battery monitoring functionality and redesigned connectors to prevent loosening and vulnerability to exposure damage.
Medtronic said it has started to remove current HVAD controllers, with product codes 1400, 1401US and 1407US in select areas. It also released updated guidelines for clinicians with these devices, recommending they update their training on the newly launched controller.
History of Issues
Problems with the implantable heart pump’s controller go back to at least April 2010. This is when HeartWare said a July 2009 redesign meant to waterproof the controllers, inadvertently made them airtight and created problems with the controller’s speaker. The company recalled controllers in February 2015 made before the FDA’s 2012 approval of the HVAD pump. Additional field warnings followed in April 2015 and April 2016 containing a number of potential issues.
There was a design problem with driveline (wire connecting the pump inside the body to the controller outside the body) connectors that connect the HVAD’s pump to the external controller and power source. The design flaw may cause fluid or other material to enter the pump and cause pump stoppage or electrical issues, according to the FDA.
In May 2015, HeartWare issued a global urgent safety notice concerning approximately 8,800 HVAD external controllers constricted with connectors that were potentially vulnerable to becoming loose, permitting moisture to enter. Moisture damage to the controller may cause the HVAD’s pump to stop working or make it difficult to detect the device’s alarm.
In August 2016, HeartWare issued a second urgent safety notice that asked hospitals to inspect their stock of un-implanted HVAD pumps and return models that may be susceptible to moisture damage. That notice suggested that the HVAD driveline, could become contaminated with fluid, leading to problems with the component connecting the driveline to the controller.
One patient may have died due to the flaw in which moisture may penetrate the mechanical pump through loose power or data connectors, said Chris Garland, a spokesman for Medtronic.
Physicians and patients were advised about the potential defect and were given instructions to closely monitor the HVAD system for loose connections, Medtronic indicated in a statement.
Ventricular assist devices, such as the HVAD, cost more than $100,000 and are among the most expensive prescribed, implantable medical devices, noted the Star Tribune.
Medtronic is headquartered in Dublin, Ireland and is among the world’s largest medical technology, services and solutions companies, alleviating pain, restoring health and prolonging life for millions of people around the world.
Advice and Information for Medical Device Problems
If you or someone you know suffered injuries regarding the use of a medical device, you may have valuable legal rights. The personal injury attorneys at Parker Waichman offer free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).