The Food and Drug Administration (FDA) has issued a recall of nearly 62,000 heart-health” target=”_blank”>pacemakers<
“If the device is unable to deliver pacing, patients may experience slow or irregular heartbeat, fainting, shortness of breath, tiredness, dizziness or discomfort,” the FDA said, on its recall notice. “Additionally, shorter battery life and device life may lead to an additional pacemaker replacement procedure sooner than expected. Finally, if the system does not relay accurate information via telemetry, medical providers may not know to provide treatment.”
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Abbott first notified patients of the issue in March, and said there was no recommendation to replace the device if there was no evidence of an issue due to low incident rate. It did recommend replacement for devices that experienced sudden battery depletions or end of service warnings, or in patients who experienced “a clinical impact.”
