Impella heart tears: Who’s affected?
The Impella CP heart pump is said to be creating tears in the heart walls of grievously ill patients. Were you or a loved one harmed by the device?
The Impella CP left-sided heart pump, a standard piece of equipment used to keep a heart beating during surgery or in patients with life-threatening conditions, is being called into question yet again.
Some 49 deaths and 129 injuries in which the heart wall is punctured have been attributed to the device, according to The Food and Drug Administration (FDA), which has issued its highest-level alert and chastised the manufacturer, Abiomed, for waiting years before posting the risk. The company, which has been purchased by Johnson & Johnson MedTech, blames doctors who insert the device and says it did not report the problem earlier because the heart tears are a well-known risk.
This is the third possibly fatal problem reported in Impella devices in one year.
Do you qualify?
If you or a loved one experienced heart wall tears due to an Impella heart pump, you may qualify to participate in an Abiomed Impella lawsuit investigation.
Please fill out the form on this page for more information.
Which devices
The pumps are used after severe heart attacks, during open-heart surgery or when the heart is not functioning well due to a condition called cardiomyopathy, according to the FDA, which called for changes in the 200-page instruction manual but did not require the company to take the devices off the market.
The Impella heart pump is designed for up to 14 days of use, the company says, but it is frequently used for a longer time in patients who are on long waiting lists for heart transplants, according to a 2022 paper in The Journal of Heart and Lung Transplantation.
Some 66,000 devices, distributed between Oct. 10, 2021, and Oct. 10, 2023, are included in the alert:
- Impella 2.5
- Impella CP
- Impella CP with SmartAssist
- Impella 5.0
- Impella 5.5 with SmartAssist
- Impella LD
The device is alleged to be the most dangerous to people undergoing surgery and to women, the elderly and those who have heart disease, according to the FDA.
Abiomed did not report issue
Abiomed did not report the problem to the FDA, which discovered the issue during an inspection in March and April 2023 at the company’s headquarters in Massachusetts, according to The New York Times:
“Inspectors turned up numerous complaints that the agency said should have been reported, and also discovered a bulletin dated October 2021 that outlined the tearing risk, according to the F.D.A.
“The bulletin, which the company said it posted on its website and on an app, described the heart-wall perforations as a ‘rare complication’ that was first noted in January 2018.”
Abiomed should have filed a report of correction or removal to the FDA within 10 days of that notice, an agency spokesperson told the Times.
Past problems
This is just the latest of Impella problems reported in 2023. Other complaints included blood clots at higher rates than expected, interactions between the pumps and transcatheter aortic valve replacement stents and leaks that could lead to failure of the device.
The FDA controversially approved the first Impella heart pump in 2008, and questions have been raised ever since. A tiny device, the pump does not require heart surgery. Rather, a doctor makes a small incision in the leg to reach the femoral artery, then guides the device with a catheter and a wire into the left ventricle, the main pumping chamber of the heart.
It was meant as an alternative to balloon pumps, which are catheters attached to a balloon that is inflated by a computer. “Yet,” The New York Times reports, “several studies have since concluded that the Impella devices are associated with higher death rates than the balloon pumps — and with far more bleeding complications.”
Join an Impella heart pump defective product lawsuit investigation
The company is accused of waiting too long to warn doctors and patients of the possible problems they might encounter leading to injury and death.
If you or a loved one were among those affected, you may qualify to participate in a lawsuit investigation.
Please fill out the form on this page to see if you qualify for a FREE case evaluation.
GET HELP – IT’S FREE
Join an Impella heart pump defective product lawsuit investigation
If you qualify, an attorney will contact you to discuss the details of your potential case at no charge to you.
After you fill out the form, an attorney(s) or their agent(s) may contact you to discuss your legal rights.
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