Boston Scientific Corp on Monday said it was suspending all sales of its implantable heart defibrillators after it failed to notify regulators of changes in how it manufactures the devices.
Its shares fell 14.4 percent to $6.66 in early trading on the New York Stock Exchange.
The company said it has voluntarily stopped shipment and was retrieving the inventory of all of its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators. It said it found two instances where it had validated but not submitted manufacturing process changes for approval to the U.S. Food and Drug Administration.
The company said it has no indication that the manufacturing changes pose any risk to patient safety and was not recommending removal of the devices.
Boston Scientific said it has informed the FDA and plans to work closely with the agency to quickly resolve the situation.
Products affected include the company's Cognis, Confient, Livian, Prizm, Renewal, Teligen and Vitality device brands. Pacemakers are not affected.
The actions could have a material impact on the company's previously issued guidance, including revenue, operating profit and cash flows for the first quarter and full year of 2010, Boston Scientific said.
(Reporting by Susan Kelly, additional reporting by Debra Sherman and Lewis Krauskopf; Editing by Derek Caney and Maureen Bavdek)