US manufacturing company Boston Scientific, which has a large plant in Galway, is recalling more than 90,000 items of a medical product used in heart surgery procedures.
The company says it is undertaking a worldwide recall of the devices, known as stents, after reports that three deaths and 43 serious injuries have been associated with their use in the US.
Stents are small expandable tubes that are inserted into diseased arteries to hold them open.
Boston Scientific is a world leader in the manufacture of life saving stents. Its plant in Galway has been in production since 1994 and employs a workforce of over 2,000.
Last night it confirmed that some of the 96,000 stents which are being recalled were manufactured in Galway. Others came from a sister plant in Minnesota.
The company said the recall was undertaken in the interest of patient safety following the linking of one death and 18 serious injuries to one type of stent and two deaths and 25 serious injuries to another.
It said the decision would not, however, affect patients who had already received these stents, because the difficulty is with the delivery system and occurs at the time of insertion and not afterward.
Company President Jim Tobin said patient safety continued to be its highest priority and it regretted the disruption the recall would cause to doctors and their patients.
Boston Scientific said that due to the recall, it now expected to record about $45m in reversals of sales and a write-down charge of about $50m.