FDA Issues Stern Warning on Medtronic Devices - WBOC-TV 16, Delmarvas News Leader, FOX 21 -

FDA Issues Stern Warning on Medtronic Devices

Posted:

WASHINGTON (AP) - 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.
 

  • Delmarvawide NewsDelmarvawide NewsMore>>

  • Delaware State Auditor Does Not Seek Re-election

    Delaware State Auditor Does Not Seek Re-election

    Feb 17, 2018 11:41 PM2018-02-18 04:41:00 GMT
    Saturday, February 17 2018 11:41 PM EST2018-02-18 04:41:58 GMT
    DOVER, De.- Delaware state auditor, Tom Wagner, has announced he will not seek re-election this year. Wagner was appointed to the position in 1989 and was elected to his seventh term in 2014. He’s one of two Republicans elected to statewide office. More
    DOVER, De.- Delaware state auditor, Tom Wagner, has announced he will not seek re-election this year. Wagner was appointed to the position in 1989 and was elected to his seventh term in 2014. He’s one of two Republicans elected to statewide office. More
  • Maryland Statehouse Hopeful Says He'll Still Hold Gun Raffle

    Maryland Statehouse Hopeful Says He'll Still Hold Gun Raffle

    Feb 17, 2018 9:16 PM2018-02-18 02:16:00 GMT
    Saturday, February 17 2018 9:16 PM EST2018-02-18 02:16:48 GMT
    A candidate for a Maryland House seat has pledged to hold a campaign fundraiser that includes raffling off an AR-15 assault rifle, the same type used in the Florida school shooting this week.More
    A candidate for a Maryland House seat has pledged to hold a campaign fundraiser that includes raffling off an AR-15 assault rifle, the same type used in the Florida school shooting this week.
    More
  • Freshmen Democrats See Most Bills Die in GOP-Led House

    Freshmen Democrats See Most Bills Die in GOP-Led House

    Feb 17, 2018 9:14 PM2018-02-18 02:14:00 GMT
    Saturday, February 17 2018 9:14 PM EST2018-02-18 02:14:01 GMT
    More than a dozen Democrats were elected to Virginia's House last fall, riding a wave of resentment against President Donald Trump. But they're having trouble keeping their bills alive in the Republican-led chamber.More
    More than a dozen Democrats were elected to Virginia's House last fall, riding a wave of resentment against President Donald Trump. But they're having trouble keeping their bills alive in the Republican-led chamber.More
  • Most Popular StoriesMost Popular StoriesMore>>

  • Traffic Stop Leads to Police Pursuit; Weapons and Drugs Seized

    Traffic Stop Leads to Police Pursuit; Weapons and Drugs Seized

    Feb 17, 2018 3:27 PM2018-02-17 20:27:00 GMT
    Saturday, February 17 2018 3:32 PM EST2018-02-17 20:32:23 GMT
    Courtesy of the Georgetown Police Department Courtesy of the Georgetown Police Department
    The Georgetown Police Department said they arrested a Brooklyn, NY, man early Friday morning after he lead them on a pursuit and had various drugs and guns in his car.More
    The Georgetown Police Department said they arrested a Brooklyn, NY, man early Friday morning after he lead them on a pursuit and had various drugs and guns in his car. More
  • Delaware State Auditor Does Not Seek Re-election

    Delaware State Auditor Does Not Seek Re-election

    Feb 17, 2018 11:41 PM2018-02-18 04:41:00 GMT
    Saturday, February 17 2018 11:41 PM EST2018-02-18 04:41:58 GMT
    DOVER, De.- Delaware state auditor, Tom Wagner, has announced he will not seek re-election this year. Wagner was appointed to the position in 1989 and was elected to his seventh term in 2014. He’s one of two Republicans elected to statewide office. More
    DOVER, De.- Delaware state auditor, Tom Wagner, has announced he will not seek re-election this year. Wagner was appointed to the position in 1989 and was elected to his seventh term in 2014. He’s one of two Republicans elected to statewide office. More
  • Teen Arrested for Threat Against High School

    Teen Arrested for Threat Against High School

    Feb 16, 2018 3:36 PM2018-02-16 20:36:00 GMT
    Friday, February 16 2018 4:07 PM EST2018-02-16 21:07:54 GMT
    Channing Fisher; Photo Credit: DPSDChanning Fisher; Photo Credit: DPSD
    Delaware State Police have arrested a Dover teenager after it was discovered that he made a threatening comment towards a high schoolMore
    Delaware State Police have arrested a Dover teenager after it was discovered that he made a threatening comment towards a high schoolMore
Powered by Frankly

All content © Copyright 2000 - 2018 WBOC. All Rights Reserved. For more information on this site, please read our Privacy Policy, and Terms of Service, and Ad Choices