Recall of Abbott Ellipse Implantable Cardioverter Defibrillators Labeled as Class I Recall by the FDA
UNITED STATES – According to an online news article published by www.healio.com, the FDA has categorized the Abbott Ellipse Implantable Cardioverter Defibrillators (ICDs) recall as Class I, the most serious categorization available.
Abbott manufactures and sells the Ellipse Implantable Cardioverter Defibrillator (ICD) that is used in patients who suffer from bradycardia (slow heartbeat), tachycardia (fast heartbeat), and heart failure. The ICD is implanted underneath the skin in the upper chest and is connected to insulated wires (i.e., “leads”) that go into the patient’s heart.
Upon learning that some Ellipse ICDs had electrical failures resulting from faulty manufacturing, Abbott issued a recall of all Ellipse ICDs, as there is no known way to determine which ICDs may have an electrical failure. According to Abbott, electrical failures may cause exposure of aluminum wires which in turn may lead to electrical shorting of the capacitor (the component which stores electrical energy).
If electrical shorting occurs, patients may not receive a flow of electrical stimulation, which is necessary for the ICD to function correctly. An ICD that does not work correctly poses a risk of harm to patients, and in some cases, patients may suffer death.
While there have been no reports of injuries or death, the United States Food and Drug Administration (FDA) has categorized the Ellipse recall as Class I, the most serious categorization available, and one that is only assigned when a medical device has the potential to cause serious injury or death.
According to Abbott, a total of 108 devices are subject to recall, 31 of which have been implanted into patients. Abbott sent a notice to customers on June 21, 2019, alerting them of the Ellipse recall and providing instructions and information on how to obtain replacement devices for patients who have the recalled Ellipse ICDs already implanted.
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