877-803-7650 | Contact Us Joe Niekro Foundation, 26780 N. 77th St. Scottsdale, AZ 85266
Donate

Knuckling Up for Brain Aneurysms, AVMs & Hemorrhagic Strokes
  • Give
    • General Donation
    • Apparel
    • Gifts in Memory
    • Gifts in Honor
    • Legacy and Planned Giving
    • Other Ways to Give
  • About Us
    • Who We Are
    • Why We Exist
    • Mission Statement
    • Founder
    • Board of Directors
    • Staff
    • Medical Advisory Board
    • Contact Us
  • Education
    • Understanding
      • Brain Basics
      • What is an Aneurysm?
      • What is an AVM?
      • What is a Hemorrhagic Stroke?
      • Types of Cerebral Aneurysms
      • Factors of a Brain Aneurysm
      • Symptoms of a Brain Aneurysm
      • Dangers of a Brain Aneurysm
      • How Does a Brain Aneurysm Develop?
      • What Happens When an Aneurysm Bleeds?
      • How is a Brain Aneursym Diagnosed?
    • Treatment
      • Unruptured Aneurysm
      • Ruptured Aneurysm
      • Clipping
      • Occlusion and Bypass
      • Endovascular Embolization / Coiling
      • Flow Diversion
      • Onyx Liquid Embolic System
      • Gamma Knife
      • Questions to Ask Your Doctor
      • Should I Get a Second Opinion?
      • Treating Physicians
  • Support
    • Joe Niekro Foundation Support Groups
    • Patient / Survivor Support Facilitators
    • Facilitator Spotlight
    • Recovery
      • Denial
      • Anger and Frustration
      • Depression
      • Bargaining
      • Acceptance
      • Post Recovery Issues
    • Caregivers
      • What a Caregiver Needs to Know
      • Recharging and Finding Balance
      • Looking After Yourself
    • What to Expect
  • Connect
    • Social Media
      • Facebook
        • Patients Online Support Group
        • Caregivers Online Support Group
        • Young Adult Online Survivor’s Support Group
        • Parents Online Support Group
        • Honoring the Taken Online Support Group
      • Twitter
      • Instagram
      • YouTube
      • Pinterest
      • LinkedIn
      • Google+
    • Stories
      • Survivors Around the Globe
      • The Caregiver’s Side
      • Honoring the Taken
      • Submit Your Story
    • Webinars
    • Blog
    • Articles
    • Videos
    • Audio
    • Public Service Announcements
    • Knuckle Up Newsletter
    • The Mighty
  • Events
    • 4th Annual Phoenix Knuckle Ball – 2018
  • Grants
    • Genetics of Sporadic Arteriovenous Malformation Study
    • Joe Niekro Research Grant
      • Grant Guidelines
      • Grant Application
      • Letter of Intent
      • Grant Recipients
    • Joe Niekro Medical Humanitarian of the Year Award
    • Joe Niekro Humanitarian of the Year Award
Home > Blog > Aneurysms > Penumbra Coil Recall…Aneurysm Device May Migrate to the Brain
  •  

    Penumbra Coil Recall…Aneurysm Device May Migrate to the Brain

    The FDA upgraded the recall of the Penumbra platinum coil for treating brain aneurysms to class I due to the potential for the device to detach and migrate, which can lead to stroke.  The Penumbra Coil 400, a medical device placed in the brain to treat an aneurysm, has been recalled because the device may migrate inside the brain, causing a stroke, blood clot or even death. 

    The Penumbra Coil 400 recall includes 267 lots — F17211 to F18553 — distributed in February 2011, according to an FDA statement.

    The small coil is placed into a brain aneurysm by threading it through blood vessels leading to the brain. Once in place, a clot forms around the coil mass, occluding the aneurysm and protecting the vessel from ruptures or leaks.

    The recalled device has a pull wire attached to an included tool used to implant the coil. The wire can slip and allow the coil to detach prematurely, migrating to unaffected areas to potentially cause serious injury, including blood clots and stroke, the FDA said.

    The coil’s manufacturer, Penumbra of Alameda, Calif., initiated the recall on March 4, 2011 notifying customers and distributors of the problem by mail, with instructions to return the recalled product to the company.

    The affected product was half-distributed in the U.S. and half-distributed internationally, the agency statement said.

    Class I recalls affect products with reasonable risk of serious adverse events or death with use.

    Any customers with questions can call Penumbra, Inc. at 510-748-3224. Any health care professionals or consumers who have experienced an adverse event due to Penumbra Coil side effects should report it through the FDA MedWatch Safety Information and Adverse Event Reporting Program.

    Posted on Saturday, April 23, 2011
  •  

    Comments

Common Questions

  • What is a brain aneurysm?
  • What is an AVM?
  • What is a hemorrhagic stroke?
  • What are the risk factors of a brain aneurysm?
  • What are the symptoms of a brain aneurysm?
  • What are the dangers of a brain aneurysm?
  • How does a brain aneurysm develop?
  • How is a brain aneurysm diagnosed?

Upcoming Events

  • 4th Annual Phoenix Knuckle Ball – 2018

News Room

  • Stories
  • Videos
  • Knuckle Up Newsletter

Connect with Us

  • Subscribe to our Knuckle-Up Newsletter
  • Become a Fan on Facebook
  • Follow us on Twitter
  • Follow us on Instagram
  • Join our Online Aneurysm/AVM Support Group
  • Join our Online Parents Support Group
  • Join our Online Young Adult Survivor’s Support Group
  • Join our Online Aneurysm/AVM Caregivers Support Group
  • Join our Online Honoring the Taken Support Group
  • Support Group Locations
  • Contact Us
  • References
  • Privacy Policy
© 2018 Joe Niekro Foundation. All Rights Reserved.
  • Mission Statement

    The Joe Niekro Foundation is committed to supporting patients and families, research, treatment and awareness of brain aneurysms, AVMs and hemorrhagic strokes. We provide education on the risk factors, causes and treatments of these conditions, while funding the advancement of neurological research.

  • Donate

    Every donation matters - every dollar counts. The Joe Niekro Foundation is a registered 501 (c)(3) which means your donations are 100% tax deductible. Your donations are used to enhance the research and treatment of brain aneursysms, AVM and hemorrhagic strokes, while supporting patients and families through the recovery process.

    Donate Now!
  • Newsletter Sign Up

    The best way to keep up to date on all the JNF happenings. Sign up today for our FREE quarterly Knuckle Up Newsletter!