In recent years, the HeartWare Ventricular Assist Device (HVAD) has become an increasingly common life-saving solution for patients with advanced heart failure. Over 19,000 patients have had the device implanted in their chests as a bridge to transplant or destination therapy when their hearts are too weak to pump blood on their own.
However, HVADs have a disturbing history riddled with red flags and safety issues that patients relying on these pumps may not be aware of.
Early Warning Signs for HVAD's
As far back as 2011, FDA inspections started uncovering manufacturing problems at HeartWare facilities related to quality control and proper staff training. HeartWare, an independent company headquartered in Massachusetts at the time, won FDA approval to sell the HVAD devices in late 2012. Severe issues started to surface in 2014, including over 100 instances of unexpected battery failures and nearly 30 cases where static electricity had short-circuited devices, leading to two patient deaths.
Despite these clear warnings that the HVAD was not meeting federal safety standards, the FDA merely issued a stern warning letter demanding fixes within 15 days. They took no real punitive action even as life-threatening issues continued for the next 8 years.
In 2016, HeartWare was acquired by medical device company Medtronic for $1.1 billion. Medtronic continued production and sale of the HVAD.
Ever-Increasing HVAD Issues and Injuries
After Medtronic acquired HVAD, patient deaths possibly related to pump malfunctions kept rising at an alarming rate. By the end of 2020, over 3,000 deaths had been reported to the FDA. Some families lost loved ones after devices shockingly stopped working due to faulty batteries or static discharges.
Medtronic amassed over 1,100 backlogged complaints of failed investigations into HVAD-related deaths and injuries. Still, the FDA relied heavily on voluntary actions by Medtronic to fix the problems – even continuing to approve expanding use of the questionable device for more patients. FDA official Dr. William Maisel defended their approach stating, “We’re talking about the sickest of the sick patients who really have very few alternatives,” Maisel said. “Our decisions that we made along the way have always been patient-focused.”
Failed Communications and Accountability
While most patients relying on the HVAD device were informed of general risks in the consent process, they had no clue of the manufacturing defects plaguing the implanted heart pumps that were keeping them alive. Faulty notice systems meant potentially thousands of patients “slipped through the cracks” without being informed of hazards with their devices. One patient’s wife, Tina W., was quoted saying: “If we had all the facts, there’s no way he would have gotten that device implanted in his heart.”
Families affected by device-related deaths faced little recourse or justice. Lawsuits related to some medical device injuries or deaths are barred in state courts by a 2008 Supreme Court ruling related to federal preemption. This means patients would need a lawyer experienced in federal proceedings and dealing with major corporations to increase their chances of seeing justice.
What Now for Remaining HVAD Patients?
In June 2021, Medtronic announced it would halt further sales and implants of the HVAD citing internal safety concerns – 12 years after the FDA first uncovered issues. The company is offering an assistance program that will station 20 specialists across the globe to help with device maintenance and patient education. A centralized engineering team will also provide technical support and troubleshooting for patients and medical staff. However, this program does not help those who have already suffered a great deal from the device.
Over 4,000 patients worldwide still rely on these devices every day to keep their hearts pumping and blood flowing. They have few alternatives other than hoping their flawed pumps don’t fail.
Other Medtronic Recalled Devices
In addition to the HVAD device, on July 18, 2023, the FDA announced a Class I recall of all Medtronic implantable cardioverter devices (ICDs) and cardiac resynchronization therapy devices (CRTD-Ds) manufactured after 2017. Like with some of the issues involving the HVAD device, these recalls are due to the risk of low or no energy output during high voltage therapy.
The following are some other Medtronic recalled devices:
- Medtronic Recalls ICDs and CRT-Ds for Risk of Low or No Energy Output (2023):
- Recalled Products: Cobalt XT, Cobalt, Crome ICDs and CRT-Ds; Claria MRI, Amplia MRI, Compia MRI, Viva, Brava CRT-Ds; Visia AF, Visia AF MRI, Evera, Evera MRI, Primo MRI, Mirro MRI ICDs.
- Distribution Dates: October 13, 2017 to June 9, 2023.
- Reason for Recall: Risk of low or no energy output
- Medtronic Recalls ICDs, CRT-Ds for Risk of Shortened Battery Life (2021):
- Recalled Products: Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy (CRT-D).
- Distribution Dates: August 31, 2012 to May 9, 2018.
- Reason for Recall: Risk of shortened battery life due to a short circuit
- Medtronic ICD Recall (2022):
- Recalled Products: Cobalt XT, Cobalt, and Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy.
- Reason for Recall: May deliver a reduced-energy shock instead of no shock at all.
Protections of Customers
This alarming case reveals gaping holes in our current system’s ability to monitor devices and protect patient safety once products are on the market. Profit-seeking manufacturers can’t be relied on alone to voluntarily fix defects without stronger oversight and penalties enforced by regulators.
Companies must be held accountable for negligent actions rather than being granted years of second chances while patient lives are lost. At Fleming, Nolen & Jez, our personal injury lawyers have dedicated their careers to fighting for the rights of injured victims throughout the United States. If you were seriously injured due to negligence or wrongdoing, you may be able to file a lawsuit to secure the compensation you deserve. Contact us today to speak with a member of our team to review your case information.