Medical devices can save lives—or they can end them. Earlier this year, the US Food and Drug Administration (FDA) issued a high-level alert concerning a heart pump used for critical care.
The Impella Left Sided Blood Pump is used during coronary procedures or in the wake of a serious heart attack (myocardial infarction). The device takes on some of the pumping capacity of the heart during surgery or can provide time for the heart to heal. The pump is small, less than the width of a pencil, and physicians guide it into place to support the heart during surgery.
According to media reports, the FDA raised concerns that the manufacturer of the pump, Abiomed, failed to notify the agency when it first posted a website warning about the pump approximately two years ago. This year certain Impella devices were recalled, as were device instructions on how cardiac surgeons might use them safely. The FDA warning concerning the recalled instructions for the pump was issued as a Class 1 recall, the most serious type of alert issued by the FDA.
The danger of the device lies in the catheter attached to the pump. The device can tear or perforate the heart, sometimes cutting through the wall of the heart and lead to “left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death,” according to the FDA. The device has injured 129 people and led to the death of 49 others. Abiomed is now owned by Johnson & Johnson.
As early as 2019, researchers identified risks from the Impella blood pump. Cardiologists at Washington University School of Medicine at St. Louis conducted an observational study and found increased risk of injury and complications for patients from stent procedures where the pumps were involved.
Researchers looked at data from 48,000 patients treated at 432 hospitals in the US. Some of the complications included kidney problems, higher risk of bleeding, stroke, or death. Lead author and cardiologist Dr. Amit Amin said that the study findings “suggest that perhaps a more measured approach — one that balances risks and benefits — is needed in this critically ill population. These data are observational, so they can’t prove causation. But they underscore the need for large, randomized clinical trials and prospective registries to better understand and guide the use of cardiac support devices.”
Lawsuits regarding Impella blood pumps are already underway. If you, or a family member, are injured through medical mistake, speak with our injury attorneys about your situation.
Talk with a trusted legal team when you suffer medical negligence
With decades of successful practice, our personal injury lawyers have obtained more than one and a half billion dollars for injury suffered by our clients in Washington DC, and Maryland. Schochor, Staton, Goldberg and Cardea, P.A. is dedicated to helping those injured through medical mistake and negligence. Call 410-234-1000 or contact us to set up a free consultation to discuss your case.