Abiomed Impella heart pump lawsuits stirrup controversy in the U.S. Impella heart pumps are designed to help the heart to recover while recuperating from injuries by assisting with the pumping function. Impella heart pump is a percutaneous catheter that is intended to help people with heart diseases by supporting heart in pumping blood.
The heart pump is inserted through a small incision and placed into the heart. The heart pump sucks blood from the left ventricle and pushes it into the aorta. This process maintains the blood flow to the various organs.
Though Impella is claimed to provide support for people with heart complications, it has some defects too. In some cases, it results in frequent cannula dislodgement or device fracture leading to complications from broken pieces entering the blood stream harming the organs.
Johnson & Johnson MedTech acquired Abiomed for $16.6 billion in 2022. They manufacture devices like Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, Impella 5.5 with Smart Assist, Impella RP, Impella RP Flex, and Impella RP Flex with SmartAssist.
Complications of Impella heart pumps like bleeding atrial fibrillation, cardiogenic shock, insertion site infection, device failure, perforation, blood clots, vascular injury and death in some cases have stirred controversy.
On April 17, 2023, Abiomed initiated a recall of its Impella 5.5® with SmartAssist® System following complaints from consumers. Around 500 devices were recalled due to damage to the purge sidearm leading to purge fluid, pump stopping its function and failing to render the support to the patient.
The FDA issued a Class I recall on Impella heart pump of around 8,000 units, distributed from May 1, 2021, to the present on June 14, 2023.
The left sided Impella heart pumps recalled for the risk of motor damage after contact with TAVR Stent shocked the consumers.
On June 29, 2023, again Abiomed recalled Impella RP Flex with SmartAssist devices due to purge fluid leak. It also recalled the labeling for the same product as the label did not provide proper warning about the blood clot risks.
Consumers who encountered injuries and loved one’s demise due to the device defect started suing Abiomed. Lawyers are investigating the issues around these heart pumps and the possibility of pursuing lawsuits.
Abiomed Impella heart pump lawsuits are still in the early stages and if more plaintiffs come forward to sue Abiomed, it can turn the wind in favor of the victims.
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