Medical device manufacturer Medtronic is recalling certain HeartWare Ventricular Assist System (HVAD) heart pumps due to the possibility of an interruption in the electrical connection between the power source and HVAD controller. The U.S. Food and Drug Administration (FDA) is classifying this recall as a Class I, which is the most serious level of recall.
In January 2020, Medtronic sent an Urgent Field Safety Notice to healthcare providers and facilities. The notice explains that there is a risk of users mistakenly inserting the battery charger AC adapter into the HVAD controller power port. Power will continue to be supplied to the pump if the battery charger is mistakenly plugged into the power port. However, the mistake can result in damage to the controller.
Heart Pump Recall Follows Patient Death
According to the FDA’s recall announcement, damage to the surfaces connecting the power source and controller could cause an interruption in the electrical connection. This interruption could cause the an unintended intermittent disconnection, which may make the pump stop.
According to Medtronic’s notice, there have been 36 adverse event complaints related to the HeartWare HVAD system. One person has died from complications associated with controller exchange. The FDA’s classification as a Class I recall means that using the device may cause “serious injuries or death.”
If the pump stops, the patient could experience:
- Exacerbation of heart failure symptoms
- Loss of consciousness
Who is At Risk from Heart Pump Recall?
Patients who are at risk from the heart pump recall are patients with end-stage heart failure. This includes patients who are completely dependent on the HeartWare system for cardiac output. Patients at the greatest risk are those with closed aortic valves and those with low ejection fraction.
The HeartWare HVAD system is primarily used by patients who have end-stage heart failure. The system is specifically designed for use in patients with left ventricular heart failure. The HeartWare system acts as a pump helping deliver blood from the heart to the rest of the body.
Patients who use the HeartWare HVAD system should talk to their healthcare provider to determine if they are using one of the products in this heart pump recall. Medtronic is urging healthcare providers to help consumers ensure that there are always two power sources connected to the HeartWare system.
Patients may receive instructions on how to properly change power sources or controllers. Whenever possible, the FDA urges patients to have a trained caregiver assist with changing power sources.
Recall Information for Consumers
This Medtronic heart pump recall affects more than 204,000 devices in the United States. Consumers can identify the products by the model numbers:
- Controller/Controller kits – 1400, 1401, 1403, 1407, and 1420
- DC Adapter – 1435 and 1440
- AC Adapter – 1425 and 1430
- Battery Pack – 1650
All serial numbers of these models are subject to the recall. The medical devices were manufactured between March 2006 and May 2018.
Consumers who have questions about the heart pump recall can contact Medtronic directly by calling 1-877-367-4823. Consumers and healthcare providers can file a complaint related to the HeartWare HVAD system through MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Legal Information for Consumers
If you have suffered an injury due to the HeartWare HVAD system or another medical device, you can also contact Drug and Device Watch to learn more about your legal rights. If you suffer harm due to a defective product you may be able to pursue compensation. Drug and Device Watch can help you find out.
For a free legal consultation, contact Drug and Device Watch by calling 1-888-458-6825. You can also submit an inquiry online via our confidential contact form.