Aug. 5 (Bloomberg) -- Boston Scientific Corp., the world's largest maker of stents used to prop open heart arteries, expanded its recall of the drug-coated Taxus heart device for a second time to include 3,000 more.

The company cited the same risk of complications during the surgery to insert the stent after receiving four more reports of patient injuries, said spokesman Paul Donovan. After two recalls in July, Boston Scientific said sales of the device plunged 18 percent to $6.5 million a day at the end of last month.

The U.S. Food and Drug Administration will meet with the company tomorrow and may broaden its probe of the recall, which now involves more than 99,000 devices. Natick, Massachusetts- based Boston Scientific's share of the $5 billion-a-year stent market fell to 55 percent at the end of July from 70 percent at the start of the recall.

``A few weeks ago people were saying that Boston's market share was going back up again -- at this point, you can pretty much forget it,'' said Susan Cross, an analyst at Wilmington Trust Co. in Delaware, which owns 50,000 Boston Scientific shares and about 9 million shares of rival stent-maker Johnson & Johnson. ``This is just going to kill it, at least for a while.''

Johnson & Johnson, the world's biggest maker of medical devices, said it is producing more of its rival Cypher stents, which were once the top sellers. Doctors at some of the biggest cardiac hospitals have reported switching to the Cypher.

Johnson & Johnson

``We have the capacity to make as many stents as needed and have ramped up production to meet any additional customer needs,'' said Rick Anderson, president of the cardiology division of Johnson & Johnson's stent-making Cordis unit.

Shares of Boston Scientific fell $2.41 or 6.6 percent, to $33.90 as of 4:15 p.m. in New York Stock Exchange composite trading. The shares have lost 21 percent since July 2. New Brunswick, New Jersey-based Johnson & Johnson slipped 36 cents to $55.22.

The FDA will meet with Boston Scientific officials tomorrow to discuss the recall in detail, according to Dan Schultz, head of the FDA division that regulates medical devices. Agency officials are concerned that the company had to expand the recall again, he said.

The agency is broadening its probe of the recall and is interested in whether the problems that have plagued the stents might pose risks for other products.

`Frank Discussion'

``We are going to be asking the company to provide assurance that all the product that's being affected is being looked at,'' Schultz said in an interview. ``We need to have a frank discussion with the company to make sure that whatever solutions are applied are being applied across the board so we don't go through this lot-by-lot and stent-by-stent.''

Physicians implant heart stents by threading a balloon- tipped catheter through blood vessels from the groin to the heart and inflating a tiny balloon within the catheter to push the stent against the vessel wall. Doctors then deflate the balloon and snake the catheter out. The stent stays in place, allowing blood to flow freely.

In some cases, the Boston Scientific balloon didn't deflate enough for physicians to pull it out through the catheter. In the worst cases, emergency bypass surgery had to be performed.

``There are two concerns,'' said Herman Gold, a cardiologist at Massachusetts General Hospital in Boston, where about 2,500 patients receive stent implants annually. ``One is the failure of the balloon to deflate. The other is their failure to reassure us that every time they withdraw these lots, it's the last of the problems.''

Massachusetts General

Gold said 60 percent to 80 percent of the stents implanted at Massachusetts General Hospital are drug-coated such as the Taxus and the Cypher. The hospital hasn't restocked Taxus stents since the July 16 recall, Gold said.

The Taxus and Cypher stents are coated with drugs to prevent the growth of tissue that can re-block arteries. Angiotech Pharmaceuticals Inc., the Canadian company that owns the rights to the cancer drug that coats the Taxus stent, fell 74 cents, or 4.6 percent, to $15.51 in Nasdaq Stock Market composite trading.

Patients who already have the device aren't at risk, because the complications arise when doctors are implanting the stents, Boston Scientific said.

Boston Scientific said it has fixed the problem. The company found that in some of its stent systems, the welded joint between the balloon and the catheter was too small, making it difficult to deflate the balloon and pull it back into the catheter.

Irish Plant

To make sure that the welded joint was big enough, the company's manufacturing facilities are inspecting the systems visually, using a microscope.

Through its monitoring of the recall, the company found that its Galway, Ireland, plant was using the wrong lens in the inspection. All 3,000 of the newly recalled stents were produced in Galway, according to Donovan.

``We immediately recalled everything that had been made in Galway in those three days,'' he said.

To contact the reporter on this story: Theresa Barry in Washington Tbarry2@bloomberg.net

Last Updated: August 5, 2004 17:00 EDT