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FDA Backs Boston Scientific Recall Plan
FDA announced that it met last week with Boston Scientific to discuss its latest recall plan and that it endorses the steps the company has taken so far. The firm has asked hospitals to remove certain models of pacemakers and implantable cardioverter-defibrillators (developed by Guidant before Boston Scientific bought it out) and asked doctors to perform follow-up exams on patients who might be affected.
July 12, 2006
1 Min Read
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The problem is linked to certain lots of a supplier's low-voltage capacitor, which controls how the device holds its power supply. Five malfunctions (but no deaths so far) have been reported in the 27,700 patients in whom the affected devices were implanted. Boston Scientific is doing the right thing by being forthcoming about the problem, which was not the case with Guidant before it was sold.
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