NEW YORK (CNNMoney.com) -- 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. 
| Markets | Last | Change | % Change |
|---|---|---|---|
| Dow | 10,465.94 | -1.22 | -0.01% |
| Nasdaq | 2,254.70 | 3.01 | 0.13% |
| S&P 500 | 1,101.60 | 0.07 | 0.01% |
| Treasurys | 2.91 | -0.09 | -3.07% |
| U.S. Dollar | 1.31 | -0.00 | -0.23% |
| Company | Price | Change | % Change |
|---|---|---|---|
| Citigroup Inc | 4.10 | -0.02 | -0.49% |
| Bank of America Corp... | 14.04 | 0.01 | 0.07% |
| Ford Motor Co | 12.77 | -0.20 | -1.54% |
| Microsoft Corp | 25.81 | -0.22 | -0.85% |
| Sprint Nextel Corp | 4.57 | -0.19 | -3.99% |
|
Russian energy giant Gazprom tops the list, while BP and Toyota round out the top 5. More |
Sure, the GDP report showed the economy is slowing. But the good news for the long term is that consumers are acting responsibly. Spending is moderate and savings are up. More |
Microsoft CEO Steve Ballmer said the company needs to create a host of iPad competitors, but he gave no timeline for when they'll come to market. More |
Kenneth Feinberg is working overtime to make sure that Gulf area businesses know him, and although obstacles loom, locals express confidence in him. More |
Stay in a house or apartment instead. You'll save big money -- and have a more authentic experience. More |
| Market indexes are shown in real time, except for the DJIA, which is delayed by two minutes. All times are ET. Disclaimer LIBOR Warning: Neither BBA Enterprises Limited, nor the BBA LIBOR Contributor Banks, nor Reuters, can be held liable for any irregularity or inaccuracy of BBA LIBOR. Disclaimer. Morningstar: © 2010 Morningstar, Inc. All Rights Reserved. Disclaimer The Dow Jones IndexesSM are proprietary to and distributed by Dow Jones & Company, Inc. and have been licensed for use. All content of the Dow Jones IndexesSM © 2010 is proprietary to Dow Jones & Company, Inc Chicago Mercantile Association. The market data is the property of Chicago Mercantile Exchange Inc. and its licensors. All rights reserved. FactSet Research Systems Inc. 2010. All rights reserved. |
