FDA Issues Recall of Defibrillation Leads
The U.S. Food and Drug Administration (FDA) issued on Jan. 22 a Class I recall – the most serious type of recall – on St. Jude’s Optisure dual coil defibrillation leads, because of a faulty insulation layer on one of the shock coils. This manufacturing error could prevent the defibrillator from delivering electrical shocks to the patient when needed, resulting in serious injury or death.
St. Jude Medical recommends that health care providers carefully monitor patients with the recalled Optisure leads. The company has also sent a medical device advisory to providers with more information.
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