FDA Issues Recall for Impella Heart Pumps Following 3 Patient Injuries and Nearly 200 Complaints
In a recent announcement, the U.S. Food and Drug Administration (FDA) has declared that Abiomed is recalling over 450 units of its Impella heart pumps due to an increased risk of purge fluid leakage from the pump’s purge sidearm.
This recall specifically affects 466 units of the Impella 5.5 with SmartAssist, which were distributed between September 2021 and March 2023. The recall was initiated on April 17, 2023. Classified as a Class I recall by the FDA, the use of these devices can result in significant injuries, including fatalities.
According to the FDA’s advisory, if a purge leak occurs, the system will encounter low purge pressures, triggering alarms and necessitating evaluation. Failure to resolve the leakage issue may lead to persistent low purge pressure and flow, potentially causing the pump to stop and the therapy to cease. For critically ill patients, the failure of the pump’s support can exacerbate their already critical condition, potentially resulting in severe harm or even death.
To date, there have been 179 complaints received regarding this issue, with three reported injuries.
Abiomed is strongly advising all customers to check if they possess any of the devices included in this recall. If they do, the products should not be used “unless no other product is available.” Customers are encouraged to contact Abiomed to coordinate the necessary product returns.
In cases where the implantation of these devices is necessary due to the unavailability of alternatives, Abiomed has provided several steps that must be followed. These steps include ensuring the device’s sidearm retainer is in place and avoiding the application of sterilization solutions containing isopropyl alcohol to the sidearm or purge filter. The complete list of instructions can be found in the FDA’s advisory, which has been directly sent to customers.
As always, both healthcare providers and patients are reminded that they can report any adverse events to the FDA using the agency’s MedWatch Online Voluntary Reporting Form.
Additional information from Abiomed regarding this recall can be accessed in PDF format here.
Please note that the latest versions of the Impella 5.5 with SmartAssist, equipped with the preinstalled sidearm retainer and the new yellow luer, are not subject to this recall.
Impella Heart Pump Wrongful Death Product Liability Lawsuits
Following the recent recall of Abiomed’s Impella heart pumps due to a heightened risk of purge fluid leakage, the potential for wrongful death product liability lawsuits has become a significant concern. With three reported injuries and nearly 200 complaints associated with this issue, affected individuals and their families may seek legal recourse to hold the manufacturer accountable for the harm caused by these defective devices.
In cases where the use of the Impella heart pumps resulted in the wrongful death of a patient, product liability lawsuits may be filed against Abiomed. Product liability refers to the legal responsibility of manufacturers, distributors, and sellers for placing defective products into the hands of consumers. In this context, the defective nature of the Impella heart pumps, as highlighted by the FDA’s recall, could form the basis of such lawsuits.
To establish a wrongful death product liability claim, several elements must be proven. First and foremost, it must be demonstrated that the Impella heart pump was defective and unreasonably dangerous. The defect could be attributed to a design flaw, manufacturing error, or inadequate warnings and instructions. In this case, the defect lies in the heightened risk of purge fluid leakage from the pump’s purge sidearm.
Secondly, it must be shown that the defect in the Impella heart pumps directly caused the patient’s death. This can be a complex task, requiring expert medical testimony and a thorough investigation into the circumstances surrounding the patient’s use of the device. However, the FDA’s classification of this recall as a Class I recall, indicating a potential for serious injuries, including death, strengthens the connection between the defect and the patient’s demise.
Furthermore, it is necessary to establish that the manufacturer, Abiomed, was negligent in designing, manufacturing, or marketing the Impella heart pumps. Negligence can be proven by demonstrating that Abiomed failed to exercise reasonable care in ensuring the safety of the product or in providing adequate warnings and instructions to users. The FDA’s recall and the subsequent lawsuits could shed light on whether Abiomed fulfilled its duty of care to consumers.
Wrongful death product liability lawsuits seek to compensate the surviving family members for the damages they have suffered as a result of the patient’s death. These damages may include medical expenses, funeral and burial costs, loss of financial support, loss of companionship, and emotional pain and suffering. The specific damages awarded in each case will depend on various factors, such as the age and earning capacity of the deceased, the number of dependents, and the circumstances of the death.
It is important for individuals who have lost loved ones due to complications associated with the Impella heart pumps to consult with experienced product liability attorneys. These legal professionals specialize in handling cases involving defective medical devices and can guide affected families through the complex legal process. They will gather evidence, engage medical experts, negotiate with the manufacturer’s legal team, and, if necessary, litigate the case in court to pursue the compensation the families deserve.
The recall of Abiomed’s Impella heart pumps and the subsequent potential for wrongful death product liability lawsuits serve as a reminder of the importance of product safety and accountability. Manufacturers must prioritize the well-being of their consumers and ensure that their products undergo rigorous testing and evaluation before entering the market. By holding manufacturers responsible for the harm caused by their defective products, consumers can seek justice and promote safer practices in the medical device industry.
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