Compensation for Your Medtronic HVAD Injuries
Medtronic, a large medical device manufacturer that distributes its products across the globe, issued a recall of its HeartWare Ventricular Assist System (HVAD) due to concerns over the safety of the device. According to reports, the company received hundreds of complaints about injuries caused by the product, and so far, more than a dozen people have died due to electrical connection issues within the device.
It is believed that problems with the connection between the HVAD controller and the electrical source (which could be an AC adapter, a DC adapter, or a battery). Interruptions within the electrical connection have caused the device to disconnect, resulting in stoppage of the pump.
According to the Food and Drug Administration (FDA), some of the adverse health effects patients with the HVAD device have suffered include:
- Arrythmia (heartblock) – requiring installation of a temporary or permanent pacemaker
- Hemorrhage or bleeding
- Acute kidney injury
- Loss of consciousness
- Other neurological symptoms
In the most tragic cases, patients have lost their lives due to pump stoppage.
Who Might Be Affected?
The Medtronic HVAD system was installed in patients who:
- Have end-stage heart failure
- Have low native heart ejection fraction
- Have fused aortic valves
- Have surgically closed aortic valves
In general, patients who are largely or entirely dependent on the HVAD system for their cardiac output could be at risk of severe injury or death.
Who Might Be Owed Compensation?
You or your family could be owed significant compensation from the device’s manufacturer if you or someone close to you:
- Needed to have your HVAD pump replaced
- Suffered a stroke, heart failure, or other neurological injuries
- Died due to electrical stoppage and pump failure
Patients who have had an HVAD system installed have been urged by the FDA to contact their physician right away. It is also recommended that you consult with a knowledgeable defective medical device lawyer to discuss your rights and legal options.
About the Recall
On April 15th, the FDA issued a Class 1 recall of the Medtronic HVAD System. Class 1 is the most urgent and serious of the three recall classifications used by the administration. Class 1 recalls will typically apply to products that the FDA is concerned will cause severe injury or death.
As of now, the manufacturer has received over 800 injury complaints and over a dozen people have died due to controller and power cabling failures that have caused the devices to stop working.
The recall affects Medtronic HeartWare HVAD system controller 2.0 ports, adapter cables, data cables, and battery cables manufactured from March 7, 2006 to the present. A complete list of the product numbers that have been recalled can be found on the FDA’s website and is listed here:
- HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports
- Product Numbers:
- Medtronic HVAD Controller AC Adapter: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US
- Medtronic HVAD Controller DC Adapter: 1440
- Battery: 1650DE
- Alarm Adapter: 1450
- Monitor Data Cable: 1575
- Controller: 1400, 1401, 1403, 1407, 1420
On June 3rd, 2021, the FDA advised against any further use of the Medtronic HVAD system. The agency said it should no longer be implanted in end-stage heart failure patients due to the increased risk of severe neurological problems and death.
Medtronic announced that it has stopped the sale and distribution of the device and issued a letter to physicians to stop new implants of the HVAD system.
What Are My Rights?
Medical devices like the Medtronic HeartWare Ventricular Assist Device (HVAD) System are supposed to help patients, not cause them harm. When manufacturers like Medtronic fail to adequately design, test, and manufacture the medical devices they sell, innocent people could suffer severe injury or death. Medtronic has a long history of recalls for these devices, starting in 2015 and again in 2018 before this most recent Class 1 recall. The manufacturer likely could have and should have done more to protect patients from being injured by this defective product.
If you’ve been hurt, or if you’ve lost a loved one due to a defective HVAD system, don’t despair. You have the right to seek answers and justice. You also shouldn’t have to pay out of pocket for invasive replacement surgeries, medical bills, and other financial losses associated with this device. You have the right to demand accountability and fair compensation, and an experienced defective medical device lawyer could help you get what you’re owed.
For a 100% free consultation to discuss your case, call us at or reach out to us online. Time is limited to take action, so don’t delay. Call now.