Medtronic, one of the world's largest producers of medical devices, made headlines last month when it announced that it was recalling nearly 15,000 guidewires following a comprehensive internal investigation, which revealed at least one patient injury and at least three other complaints.
For those unfamiliar with guidewires, they are extremely thin wires coated with polytetrafluoroethylene (PTFE) that can be threaded through blood vessels as a means to guide other medical devices into the appropriate location during heart procedures. To illustrate, a surgeon can use guidewires to help place stents in blocked arteries or to transfer the leads for an implanted pacemaker.
According to Medtronic, the 14,896 guidelines covered by the recall may have faulty PTFE coatings that can actually separate and detach, creating an elevated risk of blood clots/obstructions in the patient, which can result in heart attack or stroke. Indeed, the one aforementioned injury involved a patient who went into cardiac arrest but who was successfully resuscitated.
In recent developments, the U.S. Food and Drug Administration announced last week that the PTFE defect on the nearly 15,000 guidewires had the potential to cause serious harm or even death. As such, the agency announced that it was officially classifying Medtronic's recall action as a Class I recall, a rather serious move.
In general, recalls are undertaken by a firm on their own initiative. However, the FDA is also empowered to request that a recall be undertaken or order one using its statutory authority. The agency defines a Class I recall "as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
For its part, Medtronic claims to have introduced the necessary measures to ensure that no more defective guidewires are shipped to hospitals and distributors.
Stay tuned for updates ...
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Source: The Wall Street Journal, "FDA issues warning on recalled Medtronic device," Joseph Walker, Nov. 16, 2013