Medtronic ICDs and CRT-Ds Heart Failure and Bradycardia Lawsuit Lawyers
WASHINGTON, DC – A recall announcement published by the U.S. Food and Drug Administration is warning doctors about Medtronic’s: Amplia, Brava, Claria, Compia, Evera, Viva, and Visia implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). On April 12, 2021, the FDA announced that the recall has now been categorized as a Class I recall because the use of medical devices could cause serious injuries or death.
The FDA’s Class I Recall Notice states that some of these seven cardiac devices may have battery issues that cause full battery depletion within a single day. The devices’ sudden and unexpected decreases in battery life have been linked to a defect that causes a short circuit. According to the FDA’s announcement, the defect might cause some of the recalled devices to prematurely display a “Recommended Replacement Time” (RRT) low-battery warning and then proceed to full battery depletion in as little as 24 hours. The recall states that should the user not respond to the initial warning, the affected cardiac devices might stop working. The probability that the issue will happen is after three years of constant device use.
So far, a total of 444 incident reports have been received regarding the recalled medical devices. The affected devices were distributed from August 2012 to May 2018. 264 Medical Device Reports have been filed with 18 injuries, including heart failure and bradycardia symptoms.
The estimated number of affect devices in the United States is about 239,171. A few of the exact device models, including three models that have identical serial numbers, were recalled back in 2018 due to a separate manufacturing defect that sent dangerous electrical shocks to the patient’s heart. Medtronic issued its urgent medical device correction letter to physicians on February 3, 2021. Medtronic’s medical device status can be reviewed by serial number on Medtronic’s product performance website.
Have you or a loved one been harmed by one of Medtronic’s implantable cardioverter-defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds)?
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