Boston Scientific Announces Worldwide Recall of
Flextome Cutting Balloon® Systems
NATICK, Mass., Dec. 8, 2005 -- Boston Scientific Corporation (NYSE: BSX
-
News)
today announced that it is voluntarily recalling all Flextome Cutting Balloon® Device
Monorail® Delivery System and Peripheral Cutting Balloon® Microsurgical Dilatation
Device Small Monorail® Delivery System. No other Boston Scientific Cutting Balloon
products are affected by this recall.
The Company is initiating this recall because it has determined through complaints and testing that the distal shaft of the catheter may separate during withdrawal of the device. A shaft separation may prolong the procedure or require additional surgery. A total of eight complaints involving patients have been received by the Company, of which three required surgery. Today's action does not affect patients who have already received treatment with the recalled devices because the potential problem occurs during the procedure. The total number of devices involved in this recall is estimated at 40,000.
The Cutting Balloon Device consists of an angioplasty balloon with microsurgical blades-called atherotomes-mounted to the balloon surface. As the balloon is expanded, the atherotomes score the lesions with incisions, allowing the balloon to dilate the vessel with less pressure. Balloon angioplasty is often used to open blocked arteries or vessels.
The products affected by this recall were distributed to hospitals worldwide. Boston Scientific is notifying affected hospitals through detailed recall notification letters, including instructions on how to return recalled product.
The Company is working with the U.S. Food and Drug Administration (FDA) and is notifying officials in other countries of this recall.
Boston Scientific is requesting that product no longer be used on patients and be returned to Boston Scientific. To arrange for return of affected product, contact Boston Scientific at 1-800-811-3211.
The Flextome Cutting Balloon Device Monorail Delivery System and Peripheral Cutting Balloon Microsurgical Dilatation Device Small Monorail Delivery System generated revenues of approximately $13 million year to date in 2005.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: http://www.bostonscientific.com.
This press release contains forward-looking statements. The Company wishes to caution the reader that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with the regulatory process, litigation, competitive product offerings and other factors described in the Company's filings with the Securities and Exchange Commission.
Source: Boston Scientific Corporation |
