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 Guidant Corp., of St. Paul, Minn., for $28.4 billion. The recall impacts seven brands of Boston Scientific defibrillators: COGNIS®, CONFIENT™, LIVIAN™, PRIZM™, RENEWAL®, TELIGEN® and VITALITY™. The Company’s pacemakers and other products are not affected by the is action.
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.
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