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.
President and CEO Ray Elliott said the problem was discovered during a planned review of the Natick, Mass.-based firm’s manufacturing processes.
"We are acting voluntarily and expeditiously to resolve this situation, and we have seen no evidence of any risk to patient safety. We apologize for the inconvenience these actions will cause patients and physicians," Elliott said in prepared remarks.