The United States Food and Drug Administration (FDA) has identified Boston Scientific’s Cardiac Resynchronization Therapy Pacemakers as a Class I recall. This is the FDA’s most severe type of recall. The recall was initiated after it was discovered that a defect increased the risk of “incorrect transition to safety mode.”
According to the FDA, the device’s safety mode is designed to give a backup when the Ingenio device is faulty. Should a device accidentally switch to safety mode, there is a risk of loss of pacing and sensing of muscle contractions, which may lead to serious injury or death. Moreover, when there is an incorrect transition to safe mode, the device is unable to be reprogrammed and needs to be replaced.
The affected pacemakers and Cardiac Resynchronization Therapy devices include model numbers:
- K184, and
The devices were distributed between November 1, 2011, and August 1, 2020.
According to the FDA’s announcement, there have been approximately 65 reported incidents, which included three injuries that necessitated temporary external pacing.
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