Guidant Recalls Aorta Patch Product

Guidant Corp., which makes products that treat heart disease, said it halted production and sales of a patch for weakened spots in the aorta because of “regulatory issues associated with the deployment system of the product.” Guidant is voluntarily recalling the product, known as the Ancure System, from hospitals, a move that will result in first-quarter charges of $12 million to $15 million. The patch product accounts for about 3% to 4% of Guidant’s sales. The Indianapolis-based company said that patients who already have received the device won’t be affected. Guidant said it will meet with the Food and Drug Administration to discuss “deficiencies,” which it didn’t specify. Guidant won regulatory approval to sell the patch in September 1999, which put it in competition with Medtronic Inc.’s AneuRx Stent Graft. Guidant spokesman Steven Tragash declined to comment on the recall. The Ancure System is manufactured in Menlo Park, Calif. Guidant shares fell $1.40 to close at $48.43 on the New York Stock Exchange before news of the recall was announced.