Boston Scientific holds ICD, CRT shipments on FDA snafu
March 15, 2010 by MassDevice staff
Boston Scientific Corp.'s stock dips on news that it's holding all shipment of its implantable cardiac defibrillators and cardiac resynchronization therapy devices, after discovering it missed filings with the Food & Drug Administration.
Boston Scientific Corp. (NYSE:BSX) is holding all shipments of its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators and pulling all inventory from the field after discovering that it missed a pair of filings with the Food & Drug Administration.
The medical device-making giant said it failed to notify the FDA of two changes to its manufacturing process for its Cognis, Confient, Livian, Prizm, Renewal, Teligen and Vitality ICDs and CRT-Ds. The changes were "successfully validated" and there is no risk to patient safety, according to a press release. Boston Scientific's pacemakers and other products are not affected by the move.
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