said Friday that it has voluntarily stopped production and sales of the
system, which is used to treat life-threatening abdominal aortic aneurysms.
The company halted production after finding deficiencies with its Ancure-related regulatory processes and following discussions with the
Food and Drug Administration
"The FDA has been notified and a meeting has been scheduled to discuss these issues,'' the company said in a statement. ''This review is a top priority and we will be doing everything we can to correct the deficiencies and their causes and to resume normal operations as soon as possible.''
The problems are limited to the regulatory issues associated with the deployment system of the product, the company said. The Ancure system accounts for about 3% to 4% of Guidant's sales. The company will take a charge of $12 million to $15 million in the first quarter associated with the recall of the existing systems in hospitals. Excluding the charge, Guidant is still comfortable with earnings estimates for the period, which call for the company to earn 41 cents a share, according to
First Call/Thomson Financial
Shares of Guidant, which is based in Indianapolis, fell $1.40, or 2.8%, to $48.43 at the close of
New York Stock Exchange
Earlier today, the company said it received FDA
approval to market Powersail and Highsail, two new catheters designed to treat blocked coronary arteries.