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 the devices were recalled, and what you can do if you or someone you know was injured or died due to a malfunctioning heart pump.
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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 design of the device is based on Archimedes’ screw, which was used for raising water in ancient Greece and Egypt and looks similar to a small straw. It has been recognized for being an easy-to-initiate, low maintenance option for the treatment of cardiogenic shock.
What is the Abbott HeartMate?
The HeartMate™ II and 3 are heart devices manufactured by Thoratec Corp., a subsidiary of Abbott. Like the Impella® heart pump, the HeartMate assists with blood flow from the left ventricle to the rest of the body. The devices are designed for people experiencing 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, the pump has been linked to 49 deaths and more than 120 additional injuries.
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
Additionally, the HeartMate II and 3 were recalled in February 2024. Like the Impella heart pump, the recall of these HeartMate products is listed as a Class I recall and is a product correction rather than a product removal.
The recall was issued after it was discovered these HeartMate devices can cause Extrinsic Outflow Graft Obstruction (EOGO). 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.
Currently, 14 deaths and approximately 275 injuries have been linked to the HeartMate II and 3. 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.
Abbott/Abiomed heart pump lawsuits
Impella® is a registered trademark of Abiomed, Inc. HeartMate™ II and HeartMate™ 3 are trademarked by 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.
