Guidant Voluntarily Recalls Artery Stent

Guidant Makes Voluntary, Partial Recall of Artery Stent Over Quality Issues

Oct 8, 2003 | AP Guidant Corp. has begun a voluntary, partial recall of a stent that won federal approval less than three months ago, the company disclosed Wednesday.

The Indianapolis-based medical device maker is recalling certain lots of its three millimeter-diameter Multi-Link Vision stent because some of the devices failed in quality tests. A stent is a metal-mesh tube inserted into a coronary artery to prop it open after a blockage has been cleared.

Patients who already have received the stents are not affected by the recall, but doctors have been notified, the company said.

The recall involves stents shipped in the United States and to Europe and Australia. Guidant received U.S. approval for the stents on July 16 from the Food and Drug Administration.

At the time of FDA approval, Guidant said the new stent could be used to treat more challenging blockages and did not seem to allow reclogging as much as other stents.

Guidant said it was working with the FDA and other regulatory bodies on the recall.

Information on how many stents were involved in the recall and the defect was not immediately available.