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.