St. Jude recalls heart-plug component as FDA warns of fatal risk
|St. Jude Medical is recalling a component of its Amplatzer PFO Occluder--courtesy of St. Jude Medical|
The FDA has assigned its most-serious Class I tag to the recall, saying that in a small number of cases, the distal end of the device's core wire can fracture, possibly leading to severe adverse events including death. St. Jude informed customers of the recall in mid-January, the FDA says, and the company is in the midst of dispatching sales associates to replace the devices.
So far, no injuries have been reported, a St. Jude spokeswoman told Bloomberg, and doctors can safely use an older version of the delivery device in future Amplatzer PFO procedures.
The recall doesn't affect the Amplatzer heart plug, a device designed to prevent future strokes by plugging a hole between the heart's upper chambers called the patent foramen ovale. But St. Jude still has to deal with growing skepticism over the device's effectiveness. In October, a study found that Amplatzer PFO didn't significantly reduce the rate of repeat strokes after 12 years, likely hurting the company's chances of getting an expanded FDA indication for the plug.
St. Jude's said it's "taking a conservative approach" in yanking the delivery components, but the net result is another recall for a devicemaker plagued with regulatory failings and industry-wide whispers over the past year. Last month, St. Jude disclosed that it received an FDA warning letter over manufacturing practices at a plant that produces Durata ICD leads, only adding to the worry that St. Jude is on the verge of another large-scale recall that could blunt profits.