Boston Scientific sinks on FDA review foulup

By Ben Rooney, staff reporter

NEW YORK ( -- Shares of Boston Scientific fell sharply Monday after the biotechnology company said it has stopped delivery of certain implantable devices for patients with heart disease.

The Natick, Mass-based company's stock was down 16% to $6.50 in morning trading.


The company said it has identified two instances when changes in the manufacturing process for the devices were not submitted for approval to the U.S. Food and Drug Administration.

"A planned process review revealed that two manufacturing process changes were not submitted for FDA approval," said Boston Scientific chief executive Ray Elliott in a statement. "We apologize for the inconvenience these actions will cause patients and physicians."

Boston Scientific said it has no indication that the changes pose any risk to patient safety. The company said it has informed the FDA of the problem and plans to work closely with the agency to resolve this situation as soon as possible.

The devices in question, cardioverter defibrillators and cardiac resynchronization therapy defibrillators, are surgically implanted and are designed to help patients with chronic heart disease. The company said it does not recommend "explantation" of the devices.

The company said its pacemakers and other products are not affected by Monday's advisory.

Boston Scientific (BSX, Fortune 500) warned that the move could have a "material impact" on its previously issued forecasts for revenue and profit. It plans to "fully evaluate" the impact of the actions on its financial results and provide an update when the evaluation is completed. To top of page

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