Abbott’s Assurity and Endurity Implantable Pacemakers Recalled Due to Electrical Short Dangers
The U.S. Food and Drug Administration (FDA) issued a recall notice affecting approximately 62,000 Abbott implantable pacemakers that were distributed between April 2015 and February 2019 after reports of moisture getting inside the medical device leading to an electrical short. The FDA stated that there had been about 135 complaints, 135 injuries related to the electrical short. The recall affects Abbott’s Endurity and Assurity implantable pacemakers.
Implantable pacemakers work by detecting when the patient’s heart rate is too slow. Once a slow heart rate has been detected, the medical device sends a “signal to the brain” to cause the heart to beat at the correct speed. When an electrical short occurs in the pacemaker, the device could send out the wrong information, lose its pacing capabilities, impact battery life, or require replacement.
According to the FDA, if the pacemaker is incapable of delivering heartbeat pacing, patients will experience slow or irregular heartbeats, fainting, tiredness, shortness of breath, discomfort, and dizziness. The issue could also necessitate that an additional pacemaker replacement procedure is performed much sooner than expected. Moreover, if the system cannot relay accurate data via telemetry, medical providers might not identify the proper treatment.
Abbott first informed its patients of the electric shock issue back in March and stated that there wasn’t a recommendation to replace the medical device since there wasn’t evidence of a defect due to the low rate of incidents. However, the company does recommend a replacement for devices that “experienced sudden battery depletion or end of service warnings or in patients who experienced a clinical impact.”
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