Medtronic, the manufacturer of a medical implant that is alleged to have led to more than a dozen deaths, announced earlier in 2021 that it was halting sales of the product, according to the FDA. Further, Medtronic warned doctors against using unused implants that had already been sold and distributed.
The risks are so serious that, as of August 2021, the FDA had classified the Medtronic heart valve recall as a Class I recall. Class I recalls are the most serious of recalls and indicate, in the words of the FDA, that the “use of these devices may cause serious injuries or death.”
The recalled products are the HVAD Pump Implant Kits and components that are part of the HeartWare Ventricular Assist Device (HVAD) System of heart valve implants.
The FDA reported that the recall initiated on November 19, 2020, involved devices labeled PUMP 1103, PUMP 1104, and PUMP 1104JP with distribution dates between October 23, 2017, and April 30, 2020.
Later, the FDA reported that “all” Medtronic HeartWare HVAD Systems distributed between August 30, 2016 and June 3, 2021 were affected by the recall, including model numbers:
The reason for the initial recall was a problem with the internal pump components found in three specific lots of the pump systems, according to Medtronic’s December 2020 Urgent Medical Device Communication. Medtronic believes that thousands of patients in the United States have received the device implants, according to the FDA.
As of November 2020, Medtronic had received 29 complaints about this device, according to the FDA. These complaints allegedly included two deaths, eight potentially life-threatening events that happened not to result in long-term harm, and 19 “serious” injuries.
The HVAD Pump Implant Kits recall isn’t the only major recall in which Medtronic products are currently involved. In September 2021, Medtronic also recalled more than 8,800 Pipeline Flex Embolization Devices and Pipeline Flex Embolization Devices with Shield Technology, which were intended to treat brain aneurysms. The FDA identified this recall, too, as a Class I recall.
By June 2021, when the FDA had reported that Medtronic had ceased the sale and distribution of the recalled devices, the total number of complaints associated with delays and failures of HVAD pumps to restart had climbed to 106, according to a Medtronic Urgent Medical Device Communication notification letter.
This communication indicated that, of the 26 of these complaints that involved devices operating under normal conditions, four of the failures allegedly led to the death of a patient, and five incidents necessitated urgent explant of the device. The remaining 80 complaints involved devices being used in backup mode, which was reported to have led to a total of ten deaths and eight urgent explants.
In a notification letter sent on June 3, 2021, Medtronic stated that the company was halting sales and distribution of the HVAD System and cautioned doctors to “immediately stop new implants.” However, Medtronic’s safety communication went on to say that “prophylactic explant” of the system―in other words, taking out the implant preemptively, in the absence of noted problems or other risk factors “is not recommended at this time.” That’s because, “in general, the risks associated with explant will outweigh the potential benefits,” according to the FDA communication.
If a Medtronic pump fails, it could “potentially worsen a patient’s heart condition, lead to a heart attack, require hospitalization, and result in death,” the FDA reported.
The valves of the heart are supposed to ensure that blood flows through the heart in the correct direction, without leaking or flowing backward. In patients with end-stage heart failure, durable mechanical circulatory support devices, like Medtronic’s HVAD System (prior to the recall), could be implanted to help the heart pump blood through the body.
In some cases, the HeartWare HVAD System was implanted as a temporary measure for patients who were awaiting cardiac transplants. For other patients―such as those who aren’t eligible for or healthy enough to undergo a transplant―the HeartWare HVAD System could be used long-term for destination therapy.
Regardless of whether the patient is using the implanted system permanently or only until they can get a cardiac transplant, it’s crucial that the device works as intended. The problem, according to the recall, is that the pump could fail to start initially or to restart after stopping. This issue could occur during implantation, while the patient is in surgery and surrounded by medical personnel, but there may also be a risk of the pump failing to restart in the event that the pump is ever stopped at any point after the surgery.
What happens when a Medtronic pump fails to restart? If a Medtronic pump fails, it could “potentially worsen a patient’s heart condition, lead to a heart attack, require hospitalization, and result in death,” the FDA reported.
Patients who have already undergone cardiac transplants and are no longer relying on the device don’t have to worry about a pump failure. Patients who are still using the HeartWare HVAD System, however, have reason to be concerned by this recall notice.
If you or a loved one has a mechanical circulatory support device like a heart valve pump implant, your first step should be to reach out to your physician to discuss the recall, your specific risks, and any alternative treatment options. Your doctor should be able to tell you whether your implant is one of the products included in the recall and help you assess your risks.
In some instances, your doctor may recommend removing the recalled implant and/or using a different method, whether another mechanical heart valve pump or a pharmacological intervention, to keep your heart pumping blood without the potential risk of failure that has been identified in the recalled pumps.
Some patients and families allege that serious harm has already occurred in conjunction with the recalled devices. If you believe that the failure of a HeartWare HVAD System caused harm to you or a loved one or led to a loved one’s death, it may make sense to speak to an attorney (at no charge) about your situation and whether you could have the grounds for a personal injury or wrongful death claim.