Devicemaker Boston Scientific, Natick, Mass., has suspended sales of its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, according to a news release.
Boston Scientific suspends defibrillator sales
Company officials said they have stopped shipments and are recalling inventory on seven defibrillator brands because the devicemaker failed to submit recently instituted manufacturing changes to the Food and Drug Administration for approval, placing it out of compliance with regulatory rules. “A planned process review revealed that two manufacturing process changes were not submitted for FDA approval,” said Boston Scientific President and CEO Ray Elliott in the news release.
Boston Scientific's affected defibrillator product lines are Cognis, Confient, Livian, Prizm, Renewal, Teligen and Vitality. The defibrillators make up 15% of the company's total revenue, said Bernstein Global Wealth Management senior analyst Derrick Sung in a recently released research note. There is no indicated timetable for the suspension, but Sung estimated the company will lose $5 million in sales for each day it is in effect.
The company has said it plans to work with the FDA to resolve the compliance issue. Boston Scientific officials said they have seen no evidence of safety concerns as a result of the unapproved manufacturing changes, but they acknowledged that suspended sales and subsequent corrective action could affect revenue for the current fiscal year.
At midday trading, Boston Scientific was down nearly 17% from its March 12 closing price of $7.78.
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