FDA issues stern warning on Medtronic devices - 21 News Now, More Local News for Youngstown, Ohio -

FDA issues stern warning on Medtronic devices

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 This material may not be published, broadcast, rewritten or redistributed.

  • More From wfmj.comMore>>

  • 1 of 2 Ohio plane crash victims not yet identified

    1 of 2 Ohio plane crash victims not yet identified

    Monday, July 28 2014 9:48 PM EDT2014-07-29 01:48:43 GMT
    FINDLAY, Ohio (AP) - Authorities in northwest Ohio are still trying to identify one of two people killed in a weekend plane crash. One of the victims in the crash near Findlay was the CEO of an Ohio manufacturing company. A coroner was trying to identify the remains of a woman killed in the crash, but the Hancock County Sheriff's Office says DNA testing may be needed. Deputies say Ralf Bronnenmeier, CEO of Grob Systems in Bluffton, was piloting the single-engine plane that crashed early Sund...More >>
    FINDLAY, Ohio (AP) - Authorities in northwest Ohio are still trying to identify one of two people killed in a weekend plane crash. One of the victims in the crash near Findlay was the CEO of an Ohio manufacturing company. A coroner was trying to identify the remains of a woman killed in the crash, but the Hancock County Sheriff's Office says DNA testing may be needed. Deputies say Ralf Bronnenmeier, CEO of Grob Systems in Bluffton, was piloting the single-engine plane that crashed early Sund...More >>
  • TSA finds gun, ammo in Pittsburgh airport carry-on

    TSA finds gun, ammo in Pittsburgh airport carry-on

    Monday, July 28 2014 9:35 PM EDT2014-07-29 01:35:49 GMT
    IMPERIAL, Pa. (AP) - The Transportation Security Administration says it found a pistol and ammunition in man's carry-on bag as he passed through security at Pittsburgh International Airport. TSA official tell the Pittsburgh Tribune-Review that the man wasn't allowed take the gun past security, and faces up to a $11,000 civil penalty for bringing the weapon to the checkpoint. But Allegheny County police say they don't plan to charge the man with a crime because he had a license to carry the ....More >>
    IMPERIAL, Pa. (AP) - The Transportation Security Administration says it found a pistol and ammunition in man's carry-on bag as he passed through security at Pittsburgh International Airport. TSA official tell the Pittsburgh Tribune-Review that the man wasn't allowed take the gun past security, and faces up to a $11,000 civil penalty for bringing the weapon to the checkpoint. But Allegheny County police say they don't plan to charge the man with a crime because he had a license to carry the ....More >>
  • 5 Pa. reps ask NCAA to halt Penn State sanctions

    5 Pa. reps ask NCAA to halt Penn State sanctions

    Monday, July 28 2014 9:29 PM EDT2014-07-29 01:29:22 GMT
    Five Pennsylvania congressmen are asking college sports' governing body to cancel penalties against Penn State imposed as a result of the Jerry Sandusky child molestation scandal.More >>
    Five Pennsylvania congressmen are asking college sports' governing body to cancel penalties against Penn State imposed as a result of the Jerry Sandusky child molestation scandal.
    More >>
Powered by WorldNow
All content © Copyright 2000 - 2014 Worldnow and WFMJ. All Rights Reserved. For more information on this site, please read our Privacy Policy and Terms