Federal health officials say that defects in some Medtronic devices used in heart procedures are severe enough that they could cause serious injury or death.
The warning covers about 15,000 recalled guidewires, which are inserted through an artery and used to guide other devices into place, such as stents to hold open blocked arteries.
A recall of the guidewires began Oct. 21 after Medtronic received reports of four complaints, including one patient who went into cardiac arrest but was resuscitated, company spokesman Joseph McGrath said Saturday.
The recall notice warned hospitals and distributors worldwide that coating on the guidewires could break off, which could raise the possibility of blocking a blood vessel. The wires are coated to make them slide through blood vessels more easily.
Medtronic announced Friday night that the Food and Drug Administration had classified the recall as Class I, a category reserved for products with reasonable potential to cause serious injury or death.
The Minneapolis company said the recall affected certain lots made since April. The company said it has taken steps to prevent new shipments of the wires. It also has notified regulators around the world.
Problems with the guide wires can be reported to Medtronic by calling 877-526-7890 during weekdays from 8 a.m. to 5 p.m. CST; adverse reactions or quality problems can be reported to the FDA at HTTP://WWW.FDA.GOV/SAFETY/MEDWATCH/HOWTOREPORT/DEFAULT.HTM
Copyright 2013 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
Shalane Flanagan grew up in nearby Marblehead with a reverence for the Boston Marathon and dreamed, like many locals and foreign…
President Barack Obama is encouraging Americans to draw strength and inspiration from the Easter and Passover holidays.
A Tennessee woman says she made a grisly discovery while hunting for Easter eggs in her back yard with her 3-year-old son: a dead body.
A SpaceX commercial rocket blasted off from Cape Canaveral on schedule Friday afternoon and is heading to the International Space Station.
“The destruction of more than three transmission substations would cause long-term blackouts in many areas of the country,”…
Several local runners are heading to Boston this weekend to make a statement to the world.
President Barack Obama's national security adviser says anti-Semitic leaflets distributed in Ukraine were "utterly sickening"…
An Ohio woman, who eats a salad nearly every day and makes spinach smoothies, has lost her appetite for her favorite vegetable after making a…
After running more than 25 miles, exhaustion was setting in for Roswitha Goossens-Winter, but she was determined to complete the 2013 Boston…
If a judge could throw the book at a woman, he managed to do so Wednesday.