Boston, Massachusetts – The U.S. Food and Drug Administration (FDA) has raised concerns over the safety of Abiomed’s Impella Left Sided Blood Pumps, connecting them to 49 deaths and more than 120 serious injuries. Abiomed, a cardiovascular medical technology company wholly owned by Johnson & Johnson, faces scrutiny over its failure to notify the FDA about the potential risks associated with the device perforating the heart wall.
According to reports, the FDA found that Abiomed only added a brief mention of the risks on their website two years ago, failing to inform the regulatory agency adequately. The company allegedly attributed the injuries to “operator handling,” shifting blame onto healthcare providers. The FDA’s investigation revealed numerous unreported complaints against Abiomed, prompting the issuance of a warning letter in September 2023.
Patients who receive temporary implantation of the Impella device are already in a delicate state, often requiring urgent intervention to restore normal heart function. However, if the device punctures the heart wall or blood vessels, it can lead to emergency cardiac surgery with a low survival rate.
The legal landscape surrounding Abiomed’s Impella heart pumps is evolving, with potential actions against the company on the horizon. The FDA has previously issued recalls related to the device’s instructions for use, citing concerns about fractures and increased clotting risks. Individuals harmed by heart perforations while using an Abiomed Impella heart pump may have grounds for legal recourse.
Law firms are actively investigating cases of injury or death resulting from Abiomed’s Impella devices. With years of experience in product liability cases, attorneys are prepared to pursue justice for those affected by the device’s failures. It is crucial for individuals impacted by the Impella heart pump to act promptly to secure any potential legal claims.
While scientific literature has documented cases of heart perforations linked to Impella devices, further research is needed to assess the comparative risks with traditional blood pumps. As the FDA raises awareness of specific risks associated with Impella devices, the medical community is likely to delve deeper into this critical safety issue through future studies. Ultimately, the focus remains on ensuring patient safety and holding medical technology companies accountable for their products’ impacts.