Boston, Massachusetts – The FDA investigation has uncovered alarming findings regarding Abiomed’s Impella Left Sided Blood Pumps, linking them to at least 49 deaths and over 120 serious injuries. Abiomed, a cardiovascular medical technology company fully owned by Johnson & Johnson, has come under scrutiny for failing to disclose risks associated with the device. Despite generating approximately $85 billion in revenue in 2023, Johnson & Johnson’s reputation faces challenges due to the FDA’s revelations.
Reports from the FDA indicate that Abiomed neglected to inform the agency about the potential risk of the device perforating the heart walls, with a brief mention added to the company’s website two years prior. In response to mounting injuries linked to the device, Abiomed has shifted blame onto doctors, citing “operator handling” as the primary cause of problems.
Following a thorough investigation by the FDA last year, several unreported complaints led to the issuance of a warning letter to Abiomed in September 2023, signifying a serious regulatory action. The discovery of undisclosed risks related to the device raises concerns for individuals undergoing temporary implantation, revealing the possibility of emergency cardiac surgery with low survival rates if complications arise.
Legal action against Abiomed is gaining traction, with a focus on claims of heart perforations resulting from the use of the Impella device. Victims and families affected by injuries or fatalities tied to heart perforations during the device’s usage may seek recourse through legal channels to recover damages caused by the device.
Notably, our reputable law firm has a long-standing history of representing individuals impacted by corporate negligence, with over $40 billion in prior settlements and jury verdicts. Clients can rely on our expertise and commitment to pursuing justice on their behalf, with legal fees contingent on the successful recovery of compensation in each case.
Investigations into Abiomed devices, including the Impella 5.0 Blood Pump and Impella CP Blood Pump, are underway, with a focus on addressing potential risks and holding the company accountable for any harm caused to users. Scientific literature indicates a concerning trend of heart perforations associated with Impella devices, prompting further scrutiny from the medical community and signaling a need for comprehensive safety assessments moving forward.
As the FDA continues to raise awareness about the specific risks posed by Abiomed’s devices, ongoing research and studies will shed light on the comparative safety profiles of different blood pumps to better understand the implications for patient care. The evolving landscape of medical device safety underscores the importance of vigilant oversight and accountability in protecting public health.