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Boston Scientific Expands Recall of TAXUS Coronary Stent System |
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Natick, Mass., Aug. 5 -- Boston Scientific Corporation (NYSE: BSX - News) today provided an update on its TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System. On July 2 and 16, the Company announced the voluntary recall of certain TAXUS and Express2™ coronary stent systems, due to characteristics in the delivery catheters that had the potential to impede balloon deflation during a coronary angioplasty procedure, a condition known as focal neckdown, and which could result in serious injury to patients. The Company today announced that its own ongoing monitoring has revealed the need to expand the July 16th recall nationwide to include approximately 3,000 additional TAXUS stent systems, predominantly in the United States. These stent systems are within the parameters defined in the July 16th action. The Company is notifying institutions with affected units. The Company is aware of one death and 22 serious injuries associated with the balloon deflation problem for the TAXUS stent system. The Company reiterated that patients who have already received stents are not at risk, because any difficulty associated with non-deflation occurs during the implantation procedure. Clinician and patient inquiries may be directed to Boston Scientific at 800-832-7822. The Company also said that since it modified its manufacturing process, implemented new tracking software and introduced new inspection protocols, it has not yet had any confirmed no-deflate complaints caused by focal neckdown in non-recalled units, although some complaints remain under investigation. Since July 16, the Company has shipped more than 100,000 new TAXUS units. The Company announced preliminary worldwide July TAXUS net sales of $207 million, which includes approximately $17 million of sales recorded for the replenishment of recalled units ($163 million were U.S. sales and $44 million were sales outside the U.S.). Preliminary average daily U.S. net sales for the last five business days of July were approximately $6.5 million, excluding revenue related to replenishment of units. 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.
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