If you used the Abiomed Impella® heart pump and your device failed, perforating your ventricle, aorta, or other cardiac structure, you may be owed compensation. Additionally, you could have a case if you faced complications from an Abbott HeartMate™ II or HeartMate™ 3 device.
Below, we explain more about the Impella heart pump and Abbott HeartMates, why recalls affected these devices, and how you can take action if a malfunctioning heart pump caused injury or death to you or a loved one.
What is the Impella heart pump?
Impella® by Abiomed, a subsidiary of Johnson & Johnson, is known for being the world’s smallest heart pump. Abiomed’s website describes the device as improving patients’ quality of life and supporting their hearts in a safe and effective way. Specifically, the Impella heart pump is a left ventricle (LV) assist device that pumps blood from the LV into the ascending aorta. By assisting the heart in pumping, the device helps deliver blood and oxygen to the entire body while allowing the heart to rest and recover.
The device uses a design based on Archimedes’ screw, an ancient tool for raising water in Greece and Egypt, and resembles a small straw. Doctors have praised it as an easy-to-start, low-maintenance option for treating cardiogenic shock.
What is the Abbott HeartMate?
Thoratec Corp., a subsidiary of Abbott, manufactures the HeartMate™ II and 3 heart devices. Like the Impella® heart pump, the HeartMate assists with blood flow from the left ventricle to the rest of the body. These devices are designed to help people with moderate to severe left ventricular heart failure.
Abiomed Impella heart pump and Abbott HeartMate recalls
Despite the device’s ability to help many with their cardiovascular issues, the Impella heart pump may also cause significant injury. As of April 2024, reports have linked the pump to 49 deaths and over 120 additional injuries, highlighting the serious risks patients have faced.
The FDA issued a Class I recall, the most serious type of recall, in late 2023. According to their statement, “use of these devices may cause serious injuries or death.” Specifically, they addressed that the device is capable of perforating the left ventricle or, in some cases, other structures in the heart. The recall is a product correction, not a removal, and calls for customers to adhere to “new and revised warnings.”
The more than 65,000 affected devices include the following products distributed between Oct. 10, 2021 and Oct. 10, 2023:
- Impella 2.5
- Impella CP
- Impella CP with SmartAssist
- Impella 5.0
- Impella 5.5 with SmartAssist
- Impella LD
In February 2024, manufacturers recalled the HeartMate II and 3. Like the Impella heart pump, the FDA classified these HeartMate recalls as Class I. This indicates a serious risk to patients, and lists them as product corrections rather than full removals.
The recall followed the discovery that these HeartMate devices can cause Extrinsic Outflow Graft Obstruction (EOGO), a serious complication that puts patients at risk. EOGO “happens when biological material builds up between the HeartMate Outflow Graft and the Outflow Graft Bend relief or additional components added during surgery.” This buildup can make the device significantly less effective and, in some cases, can even lead to injury or death. It usually takes two or more years for buildup to become this severe.
So far, reports have linked 14 deaths and about 275 injuries to the HeartMate II and 3, highlighting the serious risks these devices can pose to patients. For a full list of affected devices, see the FDA’s recall.
Joining the Abbott HeartMate and Abiomed Impella heart pump lawsuit
Abiomed blames “operator handling” by doctors for any injuries from the device. However, according to a New York Times article, the FDA said Abiomed should have notified the agency about the Impella heart pump’s risk more than two years ago when the company first posted an update on its website about possible complications with perforation. The FDA also claimed “such a notice would have led to a much broader official agency warning to hospitals and doctors.”
Because of the multiple injuries and deaths that have resulted from Impella heart pumps and Abbott HeartMate products, several medical device lawyers are investigating claims against the manufacturers.
If you or someone you know had an Impella pump used for cardiac intervention for a serious cardiac condition or a HeartMate II or 3, and the device failed, causing serious injury or death, contact us today. You could be eligible for the Abiomed Impella heart pump lawsuit or the Abbott HeartMate lawsuit.
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Impella® is a registered trademark of Abiomed, Inc. HeartMate™ II and HeartMate™ 3 are trademarks of Abbott Laboratories. The names of these devices are used here only for the purpose of identifying the product in question. Woods & Woods, LLC is not affiliated with, sponsored by, or associated with Abbott Laboratories, Abiomed, Inc., or the U.S. Food and Drug Administration.
