The medical device industry has seen a significant number of recalls recently, many of which are “Class I,” the most serious type of recall a medical device company can face. According to the Food and Drug Administration (FDA), pharmaceutical drugs and medical devices that are subject to a Class I recall may cause serious injury or death to patients. As such, it is critical that patients and doctors become aware when a pharmaceutical drug or medical device is recalled by the manufacturer of the product or by the FDA.
Many patients rely on electronic medical devices to monitor their health, and in many cases, their very lives depend on the accuracy and reliability of such devices. One recent Class I recall involves the Medtronic HeartWare Ventricular Assist System (HVAD), a device that patients with heart failure rely upon when they are awaiting a heart transplant.
Continuous monitoring of a patient’s heart is crucial when a patient is at risk of dying from heart failure. The Medtronic HeartWare HVAD System is now subject to a recall because of reported interruptions in the device’s electrical connection between the controller and power source. Without necessary power, the HeartWare HVAD System may malfunction or shut down, posing a risk of harm to patients.
What is the Medtronic HeartWare HVAD System?
The Medtronic HeartWare HVAD System is specifically designed for use in patients suffering from end-stage left ventricular heart failure. The device is intended to be a “bridge” to heart transplantation so that a patient is more likely to survive while awaiting a new heart. As depicted in the image below, the Medtronic HeartWare HVAD system includes a pump, which delivers blood throughout the body, a controller, a driveline from the pump to the controller, a power source (AC adapter and battery), and a monitor. All components of the HeartWare HVAD System must work together to function as intended. If one component fails, the entire device may place a patient at risk of suffering serious injuries or death.
In most cases, the Medtronic HeartWare HVAD System is used in hospital settings, but may also be used to transport patients via plane or helicopter. While the device is primarily used in patients awaiting a heart transplant, the device may also be used in patients undergoing myocardial recovery or destination therapy in patients who will not ultimately receive a heart transplant.
Important FDA Information About the Medtronic HeartWare HVAD System Class I Recall
On May 2, 2018, the FDA issues a Class I recall for the Medtronic HeartWare HVAD System, and provided the following information for patients and medical providers (including doctors and hospitals):
- Product Name: Medtronic HeartWare HVAD System (all devices affected by recall)
- Model Numbers
- Controller and Controller Kits: 1400, 1401, 1403, 1407, 1420
- DC Adapter: 1435, 1440
- AC Adapter: 1425, 1430
- Battery Pack: 1650
- Serial Numbers: All
- Manufacturing Dates: March 2006 to May 2018
- Distribution Dates: March 2006 to May 2018
- Total Number of Devices Recalled in the United States: 204,017
It is important to understand that the FDA’s Class I recall applies to devices that have been sold and used over the past twelve (12) years. As such, patients who recently used the medical device should still be concerned about the recall, which affects more than 200,000 total devices.
Why is the Medtronic HeartWare HVAD System Subject to a Class I Recall?
Medtronic, the manufacturer of the HeartWare HVAD System, voluntarily issued a recall on the heart device because of interruptions in the electrical connection between the device’s power source (adapter or battery) and the controller. Interruptions have happened when the power source is connected, demonstrating that patients and medical providers cannot assume the product is working properly simply because the power source is on. The FDA safety notice states that “oxidation on the connecting surfaces between the power source connector and the controller’s power source socket” is thought to be the cause of interruptions in the electrical connection. Such electrical interruptions can cause the HeartWare HVAD System to stop or disconnect, preventing the device from doing its job.
FDA Recommendations for Doctors and Patients About the Medtronic HeartWare HVAD System
The HeartWare HVAD System recall affects patients with end-stage heart failure as well as patients who are entirely dependent on the device (such as patients with very low native heart ejection fractions and fused or surgically closed aortic valves). Therefore, these heart patients, their physicians, and hospitals should be aware of what steps to take to prevent injury and death caused by the HeartWare HVAD System. Pursuant to a letter issued by Medtronic in May of 2018, hospitals and physicians are instructed to do the following when using the HeartWare HVAD System:
- Ensure two power sources to the heart device are always connected;
- Ensure both healthcare professionals and patients follow best practice guidance when managing power sources when going to sleep and waking up; and
- Ensure patients are instructed to report any persistent or unexpected audible tones emitted from the device to their healthcare providers and await further guidance.
Because the Medtronic HeartWare HVAD System is a life-line for so many heart patients, it is important that patients have a trained caregiver nearby to help change a power source or controller. Many patients are already in a hospital or other healthcare facility when using the HeartWare HVAD System, so a caregiver may not always be necessary. For patients using the heart device at home, having a caregiver nearby is essential.
Injuries Associated with the Medtronic HeartWare HVAD System
When the Medtronic HeartWare HVAD System has interruptions in the electrical connection between the pump and the controller, the pump may stop and lead to the following injuries:
- Exacerbation of heart failure symptoms;
- Loss of consciousness; and
Patients suffering from heart failure are already in a weakened state and heavily rely on medical devices that function as intended to keep the heart pumping a sufficient amount of blood to the rest of the body. While all medical devices have the potential to fail, a medical device specifically intended to keep a patient alive is one that should not fail because of an interrupted electrical connection. Medtronic has taken the right step to recall the HeartWare HVAD System. However, many patients and healthcare providers may wonder how long Medtronic has known about the defect associated with its product, one which has the potential to cause serious injuries or death.
Contact Parker Waichman LLP Today to Schedule Your Free Consultation
If you have sustained injuries associated with the Medtronic HeartWare HVAD System or have lost a loved one because of this heart device, it is important to speak with a qualified Defective Medical Device Lawyer if you wish to pursue a potential legal claim. Because time is limited to file a claim, acting quickly can help to protect your legal rights. At Parker Waichman LLP, our nationally-recognized Defective Medical Device Lawyers have the resources, dedication, and experience to review your situation to determine if you may be entitled to compensation. To schedule a free consultation to discuss your potential legal claim, contact our office today by calling (800) YOUR-LAWYER (968-7529).
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