WASHINGTON, DC – According to a news report on tctmd.com, Boston Scientific has initiated a recall of its Ingenio pacemakers and cardiac resynchronization (CRT) medical devices because of an “incorrect transition to safety mode” risk. The U.S. Food and Drug Administration categorized the recall as a Class I recall, the most severe type of recall.
The family of pacemakers affected includes the Ingenio DR EL, Advantio DR EL, and the Viatlio DR EL.
According to the FDA alert, the device’s safety mode provides a backup when the device is malfunctioning. However, the safety mode is to be used only during an emergency because the device can lose some of its muscle contracting sensing capabilities. The recall also states that “if the device incorrectly goes into safety mode, the device cannot be reprogrammed and must be replaced.” In addition, the FDA’s warning alert stated that the use of the recalled medical devices could lead to severe health outcomes, such as the loss of pacing, the loss of heart rate regulation, increased heart failure, and death.
There have been a total of 65 adverse medical events reported concerning the recalled medical devices. Three injuries have been reported, and those patients required temporary external pacing. According to the news report, Boston Scientific launched the recall in June 2021 for device code “LWP and model numbers J174, J177, K174, K184, and K187.” Boston Scientific manufactured the affected pacing devices between September 2011 and December 2018, and the units were distributed from November 1, 2011, until August 1, 2020.
There are approximately 48,000 affected pacing devices affected in the United States affected by this recall. Boston Scientific urges physicians to weigh “patient-specific factors,” such as pacemaker dependence and the patient’s health issues, when evaluating the possible risk of the device arrantly changing to safety mode. Moreover, patients that suffer an improper transition to safety mode should be scheduled for device replacement.”
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