FDA issues stern warning on Medtronic devices - WFMJ.com News weather sports for Youngstown-Warren 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 This material may not be published, broadcast, rewritten or redistributed.

  • SpotlightSpotlightMore>>

  • Stuff the Bus!

    Stuff the Bus!

    Sunday, August 13 2017 7:52 PM EDT2017-08-13 23:52:49 GMT

    21 WFMJ, Great Clips, Cocca’s Pizza and Huntington Bank have teamed up with the United Way to “Stuff the Bus,” now through September 3rd.   

    More >>

    21 WFMJ, Great Clips, Cocca’s Pizza and Huntington Bank have teamed up with the United Way to “Stuff the Bus,” now through September 3rd.   

    More >>
  • Panerathon 2017 Team Peacock Registration

    Panerathon 2017 Team Peacock Registration

    Sunday, July 30 2017 8:13 PM EDT2017-07-31 00:13:49 GMT

    Join 21 WFMJ this year for Panerathon 2017!  We want to have the biggest team at Panerathon this year and we need your help. 

    More >>

    Join 21 WFMJ this year for Panerathon 2017!  We want to have the biggest team at Panerathon this year and we need your help. 

    More >>
  • Weather Pics

    Weather Pics

    Check out weather related pics from our viewers!  Please send your pics to weatherpics@wfmj.com.

    More >>

    Check out weather related pics from our viewers!  Please send your pics to weatherpics@wfmj.com.

    More >>
Powered by Frankly
All content © Copyright 2000 - 2017 WFMJ. All Rights Reserved. For more information on this site, please read our Privacy Policy and Terms