Boston Scientific issues recall

Boston Scientific Corp. yesterday recalled all of its Hemashield Vantage vascular grafts after disclosing that the devices could fray or tear during suturing and lead to complications.

The recall is small and affects one of the Natick company's least significant products. Boston Scientific said just 500 grafts that had not been implanted remained in the distribution pipeline yesterday. The company sells about 2,180 units a year, with earnings in 2004 of $1.2 million, it said.

For patients who received one of the implants, which are typically inserted to bypass an arterial leg blockage the danger period is three to seven days after surgery, said Boston Scientific spokesman Charles Rudnick.

''After that time, as time goes on, the risk of the graft failing is mitigated as the graft becomes incorporated into the surrounding body tissue," he said.

The company said it was aware of three reported failures. In each case, it said, the patients were successfully treated by resuturing the graft or by replacing it.

Boston Scientific said it is ''working with the US Food and Drug Administration" and also notifying officials in other countries.

Signs of a Hemashield Vantage failure include ''pain, swelling, bruising, bleeding through incision, rapid pulse, or low blood pressure," the company said.

Boston Scientific disclosed the recall after the stock market closed yesterday. In after-hours trading, its shares declined 51 cents to $27.01, a 1.9 percent dip.

Meanwhile, a trial began yesterday in Manhattan federal court on a lawsuit by Medinol Ltd., a Jerusalem-based medical device maker.

Medinol alleges Boston Scientific breached a contract to jointly manufacture arterial stents when it set up a secret factory in Ireland to make the stents on its own.

Rory Millson, a lawyer for Medinol, said the company is owed $2 billion to $4 billion in damages. Boston Scientific maintains Medinol breached the contract first.

Material from Bloomberg News was used in this report. Christopher Rowland can be reached at crowland@globe.com.