We wrote earlier this week about the differences in FDA recall classifications. As we mentioned, Class I recalls pose the highest risk to patients. In a recent Class I recall, St. Jude Medical announced at the end of 2011 that its Riata defibrillator leads could potentially injure or kill patients.
An estimated 79,000 patients remain implanted with the recalled devices. The company sent out a voluntary letter to doctors informing them that the wires, which are used to connect the devices to the heart, had a higher failure rate than was previously known. According to St. Jude, the wires inside some leads can penetrate the insulation, compromising the device’s integrity. Patients may be shocked.
As we mentioned in our previous post, patients using recalled drugs or devices need to consult with their physicians. St. Jude issued just such a recommendation.
Anne Curtis, chairwoman of medicine at the University at Buffalo in New York and a member of St. Jude’s medical advisory board, released this statement about the recall:
“At this time, no blanket statement can be made about clinical recommendations. Until more data are collected, physicians should follow standard practice of care to manage their patients with Riata silicone leads.”
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