"Latest update from FDA concerning Boston Scientific's defibrillator recall, linked to 16 fatalities"
In a significant development, medical device manufacturer Boston Scientific has issued a recall for certain implanted devices introduced between 2014 and 2018. The recall is aimed at addressing potential risks associated with the use of these devices, which, if used without correction, could potentially cause severe injuries or death.
A total of 386 serious injuries have been reported in association with this issue, and unfortunately, sixteen patient deaths have been reported as well. The recall does not involve the removal of the devices from their intended use or sale, but rather a voluntary correction process to ensure the safety of patients using these devices.
Boston Scientific has identified a correction to address the potential risks and has been working closely with healthcare providers to ensure the correction is implemented effectively. The correction process applies to all affected devices included in the recall. However, no specific details about the correction have been provided in the recall notice.
The recall notice advises healthcare providers to follow the instructions provided by Boston Scientific for the correction. The correction process does not require the removal of the devices from their current location, but rather focuses on correcting them to prevent potential harm.
It is important to note that Boston Scientific has not yet announced any plans for compensation for patients affected by the devices. Furthermore, the company has not provided a timeline for the completion of the correction process. The company is encouraging patients and healthcare providers to stay updated on the progress of the correction process.
The devices in question are manufactured by Boston Scientific, and the recall is a proactive measure taken by the company to ensure the safety of patients using these devices. The correction aims to prevent potential harm and serious injury or death associated with the devices.
Boston Scientific is committed to working with healthcare providers to ensure the correction is implemented effectively and safely. The company will continue to provide updates on the progress of the correction process and any additional information as it becomes available.
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