The Food and Drug Administration (FDA) has taken decisive action by issuing a Class I recall, the most urgent alert, for Impella heart pumps following reports of nearly 50 deaths linked to their usage. These heart pumps are crucial for providing short-term support to help pump blood in the ventricles of the heart during medical procedures or in the aftermath of a severe heart attack.
The recall specifically targets Impella Left Sided Blood Pumps due to concerns that the pump catheter may perforate the wall of the left ventricle in the heart. This perforation poses significant risks to patients, including but not limited to, left ventricle rupture, hypertension, decreased blood flow, and potentially fatal outcomes.
According to the FDA’s release, there have been 129 reports of serious injuries and 49 deaths associated with the use of these heart pumps. These incidents occurred between October 10, 2021, and October 10, 2023. The scale of the recall is substantial, affecting over 66,000 devices distributed across the United States.
In response to the FDA’s alert, the company responsible for the heart pumps has urged customers to carefully review new instructions provided. These instructions emphasize the importance of proper positioning of the pump catheter during procedures, utilizing imaging techniques when advancing the catheter, taking special precautions with high-risk patients, and thoroughly reviewing all warnings outlined in the pump’s instructions.
This urgent medical correction aims to mitigate further risks associated with the use of Impella heart pumps and ensure the safety of patients undergoing procedures involving these devices. It also underscores the critical need for healthcare facilities and personnel to swiftly implement the recommended actions to minimize harm to patients.
How to File Your Impella Heart Pump Wrongful Death Lawsuit
Victims who have suffered injuries or lost loved ones due to the malfunctioning Impella heart pumps may have legal recourse to seek compensation for their damages. In such cases, filing a product liability lawsuit against the manufacturer or distributor of the defective medical device is a viable option.
A product liability lawsuit typically involves proving that the product was defective or unreasonably dangerous, that the defect caused the plaintiff’s injuries or losses, and that the plaintiff incurred damages as a result. In the case of the Impella heart pumps, evidence of design flaws or manufacturing defects leading to the catastrophic failures reported would be crucial in establishing liability.
Navigating the legal process of filing a product liability lawsuit can be complex and challenging, especially when going up against large corporations with teams of lawyers. This is why it’s essential for victims to seek the guidance and representation of experienced product injury attorneys who specialize in handling such cases.
An attorney can provide invaluable assistance at every step of the lawsuit process, from gathering evidence and building a compelling case to negotiating with the opposing party and advocating for fair compensation on behalf of the victim. Additionally, an attorney can help victims understand their legal rights, assess the potential value of their claim, and navigate any legal hurdles that may arise during litigation.
In a product liability lawsuit concerning the Impella heart pumps, victims may be eligible to recover various types of damages, including medical expenses, lost wages, pain and suffering, and wrongful death damages for surviving family members. Pursuing legal action not only holds negligent parties accountable for their actions but also helps victims obtain the financial compensation they need to rebuild their lives and cover the costs of their injuries.
If you or a loved one has been harmed by a defective Impella heart pump, it’s crucial to take action to protect your rights and seek justice. By contacting a reputable product injury law firm like Parker Waichman LLP, you can receive personalized legal guidance and support throughout the process of pursuing compensation for your losses.
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