The U.S. Food and Drug Administration has issued its strictest Class I recall on faulty parts of St. Jude Medical Inc. devices implanted into patients to control irregular heartbeats.
The device under speculation, known as Optisure dual coil defibrillation leads, is connected to Implantable Cardioverter Defibrillators or ICDs, which monitor patients with abnormal heartbeats and then delivers an electric current to restore it to normal levels.
A failure in the Optisure Defibrillation Leads when used in patients with serious heartbeat variations could result in cardiac arrest.
A Class I recall is the strictest kind of recall issued by the FDA and is applied in situations where the use of faulty devices may cause serious injury or death.
According to the FDA, the reason for recalling the Optisure Defibrillation leads is, "...due to a manufacturing error that may have caused damage to the insulation layer of one of the shock coils. Depending on device programming and the depth of the cut, this could result in the inability of the defibrillator to deliver electrical therapy to the patient."
The device maker stated that it had advised physicians to monitor the patients who were implanted with the 447 Optisure Defibrillation leads that are the subject of the recall. At this point, St. Jude claims it has not yet received any reports of compromised performance of the device.
Of the 447 damaged Optisure Defibrillation leads, 278 were distributed in the United States, St. Jude said in a statement.
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