The U.S. Food and Drug Administration (FDA) has reclassified as a Class 1 Advisory a recent recall of high voltage defibrillator leads.
Announced in November 2015, the original recall involved St. Jude Medical’s Optisure-brand dual coil defibrillation leads. An unexpected variation in the manufacturing process reportedly resulted in a compromise of the lead insulation, with the potential for an electrical malfunction of the device. The company notified physicians who implanted the Optisure leads in patients, and has not received any reports of lead malfunction or patient injury related to the defect.
Class 1 recalls are reserved for those situations in which there is a reasonable probability that the use of a device could cause serious adverse health consequences or death.