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 This material may not be published, broadcast, rewritten or redistributed.
Grappling with fast-changing technology, Supreme Court justices debated Tuesday whether they can protect the copyrights of TV broadcasters to…
For all the tens of billions of dollars that the nation has spent on screening passengers and their bags, few airports made a comparable…
The Supreme Court on Tuesday upheld Michigan's ban on using race as a factor in college admissions.
An infant is fighting for her life after she was left alone with her mother’s dead body for several days.
Netflix is preparing a sequel unlikely to be a hit with its subscribers. The Internet video service is about to raise its prices for the…
Some student loan borrowers who had a parent or grandparent co-sign the note are finding that they must immediately pay the loan in full if…
In honor of Earth Day, the Environmental Protection Agency has compiled a list of ways to start saving energy not just on April 22, but every day.
Meb Keflezighi wore the names of the four victims who died in 2013 on his running bib as he became the first American winner since 1985.
A U.S. marshal shot and critically wounded a defendant on Monday in a federal courthouse after the man rushed the witness stand with a pen at…
With security tight, nearly 36,000 runners hit the streets Monday in the first Boston Marathon since last year's deadly bombing.