The U.S. Food and Drug Administration (FDA) has recently issued a Class I recall for the CARDIOHELP Emergency Drive, a critical medical device used for supporting heart and lung function. This is the most severe category of recall, indicating that using these devices could result in serious injuries or even fatalities.
The CARDIOHELP System is a vital medical apparatus designed to oxygenate blood and remove carbon dioxide, essentially acting as a support system for the heart and lungs for up to six hours. This system is crucial during certain medical procedures where cardiopulmonary bypass is not required. The recall specifically targets the CARDIOHELP Emergency Drive, with the affected models being 701048002 and 701076205, manufactured between August 11, 2022, and June 20, 2023, and distributed from September 14, 2022, to July 27, 2023.
The recall was initiated due to a defect in the emergency drive that could result in it becoming blocked or impaired, making it difficult or impossible to crank. This issue stems from excessive friction in the handle attachment caused by a scrounger disc, leading to a stiff hand crank. In emergency situations where rapid manual operation of the device is required, this defect could prevent adequate patient support, potentially leading to severe consequences such as ischemia, hypoxia, stroke, or even death.
To date, there have been no reported incidents of injury or death associated with this defect. The recall primarily affects healthcare providers who use the CARDIOHELP System and patients undergoing treatment that involves this system. On October 5, 2023, Getinge, the manufacturer, issued an Urgent Medical Device Removal Notice to all customers in possession of the affected devices. The notice instructs these customers to immediately identify and cease using any affected emergency drives, to inform Getinge if such a product is in use, and to ensure alternative emergency support is available.
This recall highlights the importance of product liability and the legal implications for manufacturers and users. In cases where a defective medical device causes harm, patients or their families may have grounds for a product liability lawsuit. These lawsuits can seek compensation for damages such as medical expenses, pain and suffering, and other losses. The process involves proving that the product was defective and that this defect directly caused harm.
Legal representation is crucial in navigating the complexities of such cases. An experienced attorney can guide victims through the legal process, from collecting evidence and filing a lawsuit to negotiating settlements or representing the case in court. The expertise of a lawyer ensures that victims’ rights are protected and that they receive fair compensation.
For those affected by the CARDIOHELP Emergency Drive recall, seeking legal advice is a critical step. Parker Waichman LLP, a national law firm specializing in product injury cases, offers free consultations for victims of such incidents. They can be contacted at 1-800-YOUR-LAWYER (1-800-968-7529). If you or someone you know has been impacted by this recall, reaching out to experienced legal professionals like Parker Waichman LLP can provide the necessary support and guidance during this challenging time.
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