Boston Scientific Galway plant gets FDA all-clear

US regulators have given the all-clear on Boston Scientific's Galway plant following a major recall of medical devices made at the facility.

The US company said yesterday that the inspectors from the Food & Drug Administration (FDA) found no problems at the Irish operation, one of Galway's major employers.

The plant is one of two Boston Scientific units producing the company's newest range of coronary stents, devices to keep the arteries open, which are used in angioplasty operations. Boston Scientific is the market leader in the coronary stent market.

Following reports of three deaths and 43 injuries related to malfunctioning stents, the company issued a limited product recall of 200 units in early July. This was later expanded significantly to 96,000 units.

The recalled stents were manufactured both in Galway and at the group's Minnesota factory.

Following a detailed examination of the recalled units, the company made adjustments to the manufacturing process.

Inspectors from the FDA visited arrived at the Galway plant last week. They spent a week examining the factory before departing on Tuesday.

In a statement yesterday, the company said the regulator had "reported no observations", effectively giving the company's operations the all-clear.

The FDA examined the company's Minnesota manufacturing line in July.

The Taxus stent, one of two involved in the recall, is Boston Scientific's biggest-selling product.

While the company lost market share in the wake of the recall, company officials said this week that it had regained that ground, with market share of 70 per cent at the end of August.

Boston Scientific said the recall cost it $78 million (€64 million). The company employs more than 2,500 people in Galway.

The medical device industry is increasingly important to Ireland, with 22,000 people employed in the sector. Of these, more than 8,000 people are involved in the manufacture of cardiovascular products.