The Irish Medicines Board has announced plans for a detailed examination of "all issues" related to a recall of heart surgery devices manufactured in Galway.
Boston Scientific, the market leader in the manufacture of coronary stents - devices inserted into human arteries during angioplasty surgery - recalled 96,000 of the products following reports of three deaths and 43 injuries related to them.
The recall, widened from an earlier 200-unit exercise, affects stents produced at Boston Scientific's two plants in Galway and Minnesota.
A spokesman for the company said the problems related to stents produced at both Galway and in the US, although the Medicines Board, which regulates the business here, said it was too early to say how many faulty stents came from the Irish plant.
Problems have been reported with 43 of around 500,000 Taxus stents used in surgery. These include one death and 18 injuries. The Taxus stent has proved extremely popular with hospitals since its introduction last year, helping Boston Scientific command a 70 per cent market share in stents.
The other product involved in the recall, the Express 2 (bare metal) stent, has been implicated in 52 product failures out of 600,000 uses, with two deaths and 25 serious injuries reported.
However, regulators and the company said the recall had no implications for patients who had already had the stents implanted. "The problem occurs during the initial placement and deployment of the stent and does not affect the performance of the stent itself," the Medicines Board said in a statement yesterday. The board intends to examine the Galway plant, something the US regulator the Food and Drug Administration is undertaking currently.
A Boston Scientific spokesman said the recall would have no implications for the future of the Galway plant. "We are continuing to produce both these products and, if anything, we are producing them in greater numbers than previously to make up for the numbers recalled," he said.
He said the company had made a small change to the manufacturing process following a microscopic examination of products following the recall.
Industry sources said the decision to recall the stents was a blow to a sector of growing importance to Ireland.
More than 8,000 of the 22,000 people employed in the medical devices sector in Ireland are involved in cardiovascular products.
