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Boston Scientific Corp. stock dropped more than 11 percent, after it announced it would temporarily halt shipments and recall inventory of several brands of implantable heart defibrillators because parts of the manufacturing process have not been approved by the U.S. Food and Drug Administration. The company announced that halting sales could have a material impact on its previously announced financial guidance for 2010.
“A planned process review revealed that two manufacturing process changes were not submitted for FDA approval,” said Ray Elliott, president and CEO of Boston Scientific, in a statement. “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.”
The Natick-based medical device maker said it is not recommending that physicians remove the devices from patients.
The affected products include several brands, including the Cognis, Confient, Livian, Prizm, Renewal, Teligen and Vitality product lines. The company’s pacemakers and other products are not affected .
Boston Scientific officials said they would evaluate the financial impact of these actions and provide an update to the guidance if necessary.
The company’s (NYSE: BSX) stock was trading at $6.88 in mid-morning trading on Monday, down from $7.78 at the previous close.
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