CHICAGO – Boston Scientific Corp. (BSX) Friday expanded its recall of a popular heart device because of a malfunction and said the recall would hurt its second-quarter results.
The company said the recall would involve about 85,000 Taxus drug-coated stents and 11,000 Express2 stent systems (search) after reports of deaths injuries related to the devices, which are used to clear clogged heart arteries.
Boston Scientific, which has been realizing significant profit on the new device, said its Taxus stents (search) have been linked to one death and 18 serious injuries, and the Express2 bare metal stent system to two deaths and 25 serious injuries.
The company's stock, which was halted most of the day on the New York Stock Exchange (search), resumed trade shortly before the close and ended at $37.40, off 7.6 percent.
The Natick, Mass.-based company said it sees a $45 million reversal of sales related to the recalled products in the second quarter. It said it expects a $50 million pretax charge to write down inventory when it reports second-quarter results on July 26, a delay of one week.
During a conference call with analysts, Boston Scientific Chief Financial Officer Larry Best declined to quantify the impact on earnings per share, saying it was a complicated model to work out. "It could be 4 to 6 cents or 6 to 8 cents," he said.
The news followed reports on Friday from hospitals, which had expressed concern that Boston Scientific's heart device may extend beyond the 200 stent systems recalled two weeks ago.
Brigham & Women's Hospital (search) in Massachusetts, one of the nation's leading hospitals, earlier on Friday said it pulled Boston Scientific's Taxus stent from its shelves after reports that problems with the system may extend beyond the 200 devices the company recalled two weeks ago.
Boston Scientific issued the recall after the Food and Drug Administration (search) informed it of at least one death and injuries related to the stent, which has been a big money-maker.
The move by Brigham & Women's, which is affiliated with Harvard Medical School, suggested to some doctors that the recall could have greater ramifications than originally thought.
The problem with the recalled stents involves the delivery catheters, which can prevent the balloon used to clear arteries of fatty deposits from deflating, the company said earlier.
If the balloon fails to deflate properly, it can cause complications, including death or the need for heart bypass surgery.
"Since (the recall), there have been some reports, certainly unsubstantiated and not involving our hospital, of recurring problems with non-deflation," Campbell Rogers, director of the cardiac catheterization laboratory at Brigham & Women's Hospital, told Reuters on Friday.
Rogers said none of the recalled lots were on the hospital's shelves.
Dr. Charles Davidson, who runs the cardiac catheterization laboratory at Northwestern Memorial Hospital in Chicago, said he was aware of problems outside of the two lots of stents that were recalled.
He said he had experienced no problems at his hospital.
Some analysts had speculated that the company could make an announcement regarding its relationship with Angiotech Pharmaceuticals Inc., the maker of the drug coating Boston Scientific uses for its Taxus stent. The drug coating prevents the build-up of scar tissue that can reclose the artery.
Trading in shares of Canada's Angiotech also were halted.
Shares of Johnson & Johnson (JNJ), which makes a device that competes with Boston Scientific's, touched a 15-month high on Friday. The stock, which climbed as high as $58.00 earlier in the session, closed up $1.45, or 2.62 percent, at $56.80 on the New York Stock Exchange.
Shares of cardiovascular device makers developing similar devices also rallied on the news. Guidant Corp.'s (GDT) shares closed up $1.30, or 2.44 percent, to $54.55, while shares of Medtronic Inc.(MDT) ended up 53 cents, or 1.07 percent, at $50.09.
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