Boston Scientific is issuing a massive recall of its implantable heart defibrillators. According to a Boston Scientific press release, the company is halting sales and retrieving field inventory of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) because it did not get approval from federal regulators for changes to its manufacturing processes.
All of the devices in the recall were acquired by Boston Scientific in 2006 when it purchased medical device manufacturer <"http://www.yourlawyer.com/topics/overview/guidant_defibrillators">Guidant Corp., of St. Paul, Minn., for $28.4 billion. The recall impacts seven brands of Boston Scientific defibrillators: COGNISÂ®, CONFIENTâ„¢, LIVIANâ„¢, PRIZMâ„¢, RENEWALÂ®, TELIGENÂ® and VITALITYâ„¢. The Company’s pacemakers and other products are not affected by the is action.
“A planned process review revealed that two manufacturing-process changes were not submitted for FDA approval,” Boston Scientific Chief Executive Ray Elliott said in the release. “We are acting voluntarily and expeditiously to resolve this situation, and we have seen no evidence of any risk to patient safety.”
According to The Boston Globe, Boston Scientific’s lapse was related to documentation, the paperwork that companies are required to submit to the Food & Drug Administration (FDA) whenever they make material changes in their production processes. Such changes could affect the way defibrillators deliver their electric pulses.
Boston Scientific informed the FDA on Sunday that it hadn’t filed for approval and would withdraw its devices. While Boston Scientific did not use the word “recall” in its press release, The Wall Street Journal said the FDA has characterized the action as such.
The recall is expected to take a heavy toll on the company’s bottom line. According to The Wall Street Journal, Boston Scientific will lose about $5 million in sales each day it can’t sell the devices.
This is not the first time Boston Scientific’s Guidant acquisition has proved troublesome for the device maker. In November, the company agreed to plead guilty and pay $296 million to resolve federal charges that failed to fully disclose earlier problems with its implantable defibrillators to the FDA.
In December, it also agreed to pay $22 million to settle a federal investigation into allegations that Guidant paid doctors kickbacks to get them to use its heart devices.