A new warning has been issued for a heart pump that can potentially perforate the heart. This product has been linked to at least 49 deaths and 129 serious injuries.
Shockingly, the heart pump remains in use regardless of the U.S. Food and Drug Administration’s (FDA) Class I recall, though it is the most serious type of recall. Per the FDA website, “Use of these devices may cause injury or death,” but added, “This recall is a correction, not a product removal.”
Is my heart pump being recalled?
The specific device in question is the left-sided Impella heart pump. These were created by Abiomed, a subsidiary of Johnson & Johnson MedTech.
How are Impella heart pumps causing death and injury?
Inserting a heart pump is a high-risk cardiac procedure, but this surgery is often deemed necessary as a life-saving tactic. They are helpful for certain types of heart attacks and help to maintain proper blood flow from the heart to the body.
These pumps resemble a long straw, which is inserted into the heart. It is then threaded through major heart vessels and into the left ventricle, which serves as the organ’s main pumping chamber.
“Abiomed is recalling its Impella Left Sided Blood Pumps because the pump catheter may perforate [cut] the wall of the left ventricle in the heart,” the company warned in its statement. “During operations, the Impella device could cut through the wall of the left ventricle.”
“The use of the affected Impella pumps may cause serious adverse health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death,” the warning added.
Since this recall does not include a product removal, surgeons are advised to, “carefully position the pump catheter during operative procedures.”
How long have Impella heart pumps been problematic?
The issue was disclosed in a technical bulletin years ago, in October 2021. However, the FDA was not informed at the time, and a spokesperson for the administration told CNN that the lack of communication violated agency protocol.
The FDA eventually discovered the issue, and inspected the Abiomed facility in September 2023. They issued a warning letter soon afterward.
Abiomed believes that anyone undergoing a procedure with their product should be aware of the new instructions for use – especially the elderly, women, and individuals with heart disease.
Why are these heart pumps still being used, if people are dying?
This is a good question. Product liability lawsuits are created for questionable and dangerous devices such as these. While Impella believes that their new warning enables surgeons and patients to return to business as usual, others feel that use of this product should be terminated.
Public Citizen, a consumer advocacy group, issued a statement calling for a full ban on these heart pumps.
The group stated that despite dozens of severe injuries and deaths, “the FDA has allowed them to remain in use. Moreover, there are serious and ongoing concerns about whether there are clinically meaningful survival benefits that outweigh the risks of these left ventricular assist devices.”
Dr. Robert Steinbrook, who directs Public Citizen’s Health Research Group, has spoken out in regard to the dangers of this product. “Given the ongoing safety concerns about Impella left ventricular assist devices and this new recall, it is woefully inadequate to revise an instruction manual and to tell cardiologists to be more careful,” Steinbrook said in a statement. “The use of these left ventricular assist devices should be stopped.”
“Better treatments are urgently needed,” Steinbrook added, and “in the future, these devices should only be used in patients enrolled in a randomized, controlled trial that compares the devices to medical [drug] management.”
Has the FDA recently recalled other heart pumps?
Yes, and two recent issues remain relevant today:
Heart Mate II and Heart Mate 3
Just recently, Abbott Laboratories had their Heart Mate II and Heart Mate 3 subject to a Class I recall by the FDA, after multiple deaths and injuries.
If the new recall leads to the device being removed from the market, end-stage heart failure patients could have no options, warns Francis Pagani, a cardiothoracic surgeon at the University of Michigan. He also oversees a proprietary database of HeartMate II and HeartMate 3 implants.
If that happens, “we are in trouble,” Pagani said. “It would be devastating to the patients to not have this option. It’s not a perfect option — no pump ever is — but this is as good as it’s ever been.”
HeartWare Ventricular Assist Device (HVAD)
Thousands of people were implanted with a heart pump that the FDA knew was dangerous, and it’s been a cause for scandal. FDA inspectors repeatedly found manufacturing and device quality problems with the HeartWare heart pump.
After these inspections, the FDA put HeartWare on notice for not properly monitoring or repairing HVAD defects, such as faulty batteries and short circuits caused by static electricity, which had killed multiple patients. The agency issued a warning letter, one of its most serious citations. It demanded fixes within 15 days.
Unfortunately, the FDA took no decisive action as problems persisted. HeartWare was not penalized, and patients had the device implanted without knowing the facts.
Heart pumps and product liability lawsuits
Though heart pump surgery is intended to improve a patient’s quality of life, there are many variables at hand, and no one can promise a failsafe result.
That being said, there should always be safeguards in place that businesses and agencies are able to control. At the very least:
- There should be a guarantee that the FDA and every medical tech company are working in tandem to create the most effective products possible.
- Testing must be conducted thoroughly, and often. The reporting should be equally thorough.
- There should be regular communication on progress and open issues.
- There must be a penalization process if medical tech companies are not adhering to best practices and providing clear information to the public.
- There should be oversight to ensure that special interest groups, such as lobbyists, do not hinder the process. Patients over profit should be the maxim.
Unfortunately, this is not always the case and the aftermath of these oversights have ended in dozens of deaths and injuries. Unsurprisingly, this has led to product liability lawsuits, where families have sued for brain damage that resulted from a lack of blood flow to the brain. Wrongful death lawsuits have been filed against heart pump manufacturers with irresponsible reporting, and not following best practices.
If you or a loved one have suffered from a malfunctioning heart pump or other medical device, the seasoned product liability attorneys at Allen & Allen are here to help. We can aid you in navigating complicated medical records, legal procedures, and research. For a free case evaluation, call us today at 866-388-1307.
