Recall for Boston Scientific Implantable DefibrillatorsMar 16, 2010 | Parker Waichman LLP
A massive recall is being issued for seven brands of Boston Scientific implantable heart defibrillators. The recall is being issued because Boston Scientific has determined that it did not get approval from federal regulators for changes to its manufacturing processes.
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. The seven brands affected are: COGNIS®, CONFIENT™, LIVIAN™, PRIZM™, RENEWAL®, TELIGEN® and VITALITY™. The Company's pacemakers and other products are not affected by the is action.
All of the devices in the recall were acquired by Boston Scientific in 2006 when it purchased medical device manufacturer Guidant Corp., of St. Paul, Minn., for $28.4 billion.
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.