Events

Recall of Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Guidant Endovascular Solutions, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    33117
  • Event Risk Class
    Class 2
  • Event Number
    Z-1586-05
  • Event Initiated Date
    2005-08-08
  • Event Date Posted
    2005-09-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41342
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
  • Reason
    This action is being taken as a preventative measure as a result of an increased rate of complaints associated with stents becoming loose or dislodged from the delivery catheter.
  • Action
    (1 )Identify all customers world wide who have been shipped affected product from 01/01/2003 through 08/03/2005. (2)Contact and coordinate with LA District FDA Recall Coordinator, KEMA Notified Body, and other Competent Authorities outside the US as mandated by country local law. (3)Deliver Physiciam Medical Device recall Notice and Reconciliation Form via Federal Express in US/Mexico/ Puerto Rico. (4)Reconcile receipt notification and physical product returns to expected returns.

Device

Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems
  • Model / Serial
    Model number of the device and manufacturing lots involved: OTW OmniLink 18 1007942-18 OTW OMNI 18 5.0MMX18MMX135CM 1007944-18 OTW OMNI 18 6.0MMX18MMX135CM 1007946-18 OTW OMNI 18 7.0MMX18MMX135CM 1007948-18 OTW OMNI 18 8.0MMX18MMX135CM 1007949-18 OTW OMNI 18 9.0MMX18MMX135CM 1007950-18 OTW OMNI 18 10.0MMX18MMX135CM 1007980-18 OTW OMNI 18 5.0MMX18MMX80CM 1007982-18 OTW OMNI 18 6.0MMX18MMX80CM 1007984-18 OTW OMNI 18 7.0MMX18MMX80CM 1007986-18 OTW OMNI 18 8.0MMX18MMX80CM 1007987-18 OTW OMNI 18 9.0MMX18MMX80CM 1007988-18 OTW OMNI 18 10.0MMX18MMX80CM 1007942-28 OTW OMNI 18 5.0MMX28MMX135CM 1007944-28 OTW OMNI 18 6.0MMX28MMX135CM 1007946-28 OTW OMNI 18 7.0MMX28MMX135CM 1007948-28 OTW OMNI 18 8.0MMX28MMX135CM 1007949-28 OTW OMNI 18 9.0MMX28MMX135CM 1007950-28 OTW OMNI 18 10.0MMX28MMX135CM 1007980-28 OTW OMNI 18 5.0MMX28MMX80CM 1007982-28 OTW OMNI 18 6.0MMX28MMX80CM 1007984-28 OTW OMNI 18 7.0MMX28MMX80CM 1007986-28 OTW OMNI 18 8.0MMX28MMX80CM 1007987-28 OTW OMNI 18 9.0MMX28MMX80CM 1007988-28 OTW OMNI 18 10.0MMX28MMX80CM 1007942-38 OTW OMNI 18 5.0MMX38MMX135CM 1007944-38 OTW OMNI 18 6.0MMX38MMX135CM 1007946-38 OTW OMNI 18 7.0MMX38MMX135CM 1007948-38 OTW OMNI 18 8.0MMX38MMX135CM 1007949-38 OTW OMNI 18 9.0MMX38MMX135CM 1007950-38 OTW OMNI 18 10.0MMX38MMX135CM 1007980-38 OTW OMNI 18 5.0MMX38MMX80CM 1007982-38 OTW OMNI 18 6.0MMX38MMX80CM 1007984-38 OTW OMNI 18 7.0MMX38MMX80CM 1007986-38 OTW OMNI 18 8.0MMX38MMX80CM 1007987-38 OTW OMNI 18 9.0MMX38MMX80CM 1007988-38 OTW OMNI 18 10.0MMX38MMX80CM 1007942-58 OTW OMNI 18 5.0MMX58MMX135CM 1007944-58 OTW OMNI 18 6.0MMX58MMX135CM 1007946-58 OTW OMNI 18 7.0MMX58MMX135CM 1007948-58 OTW OMNI 18 8.0MMX58MMX135CM 1007949-58 OTW OMNI 18 9.0MMX58MMX135CM 1007950-58 OTW OMNI 18 10.0MMX58MMX135CM 1007980-58 OTW OMNI 18 5.0MMX58MMX80CM 1007982-58 OTW OMNI 18 6.0MMX58MMX80CM 1007984-58 OTW OMNI 18 7.0MMX58MMX80CM 1007986-58 OTW OMNI 18 8.0MMX58MMX80CM 1007987-58 OTW OMNI 18 9.0MMX58MMX80CM 1007988-58 OTW OMNI 18 10.0MMX58MMX80CM 1007940-12 OTW OMNI 18 4.0MMX12MMX135CM 1007942-12 OTW OMNI 18 5.0MMX12MMX135CM 1007944-12 OTW OMNI 18 6.0MMX12MMX135CM 1007946-12 OTW OMNI 18 7.0MMX12MMX135CM 1007978-12 OTW OMNI 18 4.0MMX12MMX80CM 1007980-12 OTW OMNI 18 5.0MMX12MMX80CM 1007982-12 OTW OMNI 18 6.0MMX12MMX80CM 1007984-12 OTW OMNI 18 7.0MMX12MMX80CM 1007940-16 OTW OMNI 18 4.0MMX16MMX135CM 1007942-16 OTW OMNI 18 5.0MMX16MMX135CM 1007944-16 OTW OMNI 18 6.0MMX16MMX135CM 1007946-16 OTW OMNI 18 7.0MMX16MMX135CM 1007978-16 OTW OMNI 18 4.0MMX16MMX80CM 1007980-16 OTW OMNI 18 5.0MMX16MMX80CM 1007982-16 OTW OMNI 18 6.0MMX16MMX80CM 1007984-16 OTW OMNI 18 7.0MMX16MMX80CM 1007978-18 OTW OMNI 18 4.0MMX18MMX80CM 1007940-18 OTW OMNI 18 4.0MMX18MMX135CM  US Part Numbers Omnilink .035 1008159-18 OTW OMNI 35 4.0MMX18MMX135CM 1008161-18 OTW OMNI 35 5.0MMX18MMX135CM 1008163-18 OTW OMNI 35 6.0MMX18MMX135CM 1008165-18 OTW OMNI 35 7.0MMX18MMX135CM 1008167-18 OTW OMNI 35 8.0MMX18MMX135CM 1008168-18 OTW OMNI 35 9.0MMX18MMX135CM 1008169-18 OTW OMNI 35 10.0MMX18MMX135CM 1008174-18 OTW OMNI 35 4.0MMX18MMX80CM 1008176-18 OTW OMNI 35 5.0MMX18MMX80CM 1008178-18 OTW OMNI 35 6.0MMX18MMX80CM 1008180-18 OTW OMNI 35 7.0MMX18MMX80CM 1008182-18 OTW OMNI 35 8.0MMX18MMX80CM 1008183-18 OTW OMNI 35 9.0MMX18MMX80CM 1008184-18 OTW OMNI 35 10.0MMX18MMX80CM 1008161-28 OTW OMNI 35 5.0MMX28MMX135CM 1008163-28 OTW OMNI 35 6.0MMX28MMX135CM 1008165-28 OTW OMNI 35 7.0MMX28MMX135CM 1008167-28 OTW OMNI 35 8.0MMX28MMX135CM 1008168-28 OTW OMNI 35 9.0MMX28MMX135CM 1008169-28 OTW OMNI 35 10.0MMX28MMX135CM 1008176-28 OTW OMNI 35 5.0MMX28MMX80CM 1008178-28 OTW OMNI 35 6.0MMX28MMX80CM 1008180-28 OTW OMNI 35 7.0MMX28MMX80CM 1008182-28 OTW OMNI 35 8.0MMX28MMX80CM 1008183-28 OTW OMNI 35 9.0MMX28MMX80CM 1008184-28 OTW OMNI 35 10.0MMX28MMX80CM 1008161-38 OTW OMNI 35 5.0MMX38MMX135CM 1008163-38 OTW OMNI 35 6.0MMX38MMX135CM 1008165-38 OTW OMNI 35 7.0MMX38MMX135CM 1008167-38 OTW OMNI 35 8.0MMX38MMX135CM 1008168-38 OTW OMNI 35 9.0MMX38MMX135CM 1008169-38 OTW OMNI 35 10.0MMX38MMX135CM 1008176-38 OTW OMNI 35 5.0MMX38MMX80CM 1008178-38 OTW OMNI 35 6.0MMX38MMX80CM 1008180-38 OTW OMNI 35 7.0MMX38MMX80CM 1008182-38 OTW OMNI 35 8.0MMX38MMX80CM 1008183-38 OTW OMNI 35 9.0MMX38MMX80CM 1008184-38 OTW OMNI 35 10.0MMX38MMX80CM 1008161-58 OTW OMNI 35 5.0MMX58MMX135CM 1008163-58 OTW OMNI 35 6.0MMX58MMX135CM 1008165-58 OTW OMNI 35 7.0MMX58MMX135CM 1008167-58 OTW OMNI 35 8.0MMX58MMX135CM 1008168-58 OTW OMNI 35 9.0MMX58MMX135CM 1008169-58 OTW OMNI 35 10.0MMX58MMX135CM 1008176-58 OTW OMNI 35 5.0MMX58MMX80CM 1008178-58 OTW OMNI 35 6.0MMX58MMX80CM 1008180-58 OTW OMNI 35 7.0MMX58MMX80CM 1008182-58 OTW OMNI 35 8.0MMX58MMX80CM 1008183-58 OTW OMNI 35 9.0MMX58MMX80CM 1008184-58 OTW OMNI 35 10.0MMX58MMX80CM 1008159-12 OTW OMNI 35 4.0MMX12MMX135CM 1008161-12 OTW OMNI 35 5.0MMX12MMX135CM 1008163-12 OTW OMNI 35 6.0MMX12MMX135CM 1008165-12 OTW OMNI 35 7.0MMX12MMX135CM 1008174-12 OTW OMNI 35 4.0MMX12MMX80CM 1008176-12 OTW OMNI 35 5.0MMX12MMX80CM 1008178-12 OTW OMNI 35 6.0MMX12MMX80CM 1008180-12 OTW OMNI 35 7.0MMX12MMX80CM 1008159-16 OTW OMNI 35 4.0MMX16MMX135CM 1008161-16 OTW OMNI 35 5.0MMX16MMX135CM 1008163-16 OTW OMNI 35 6.0MMX16MMX135CM 1008165-16 OTW OMNI 35 7.0MMX16MMX135CM 1008174-16 OTW OMNI 35 4.0MMX16MMX80CM 1008176-16 OTW OMNI 35 5.0MMX16MMX80CM 1008178-16 OTW OMNI 35 6.0MMX16MMX80CM 1008180-16 OTW OMNI 35 7.0MMX16MMX80CM
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide and Argentina, Austria, Bahrain, Belgium, Brazil, Bulgaria, Chile, Czech Republic, Dominican Republic, Findland, France, Germany, Greece, Hungary, Israel, Italy, Jordan, Lebanon, Malta, Mexico, Netherlands, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, South Africa, Spain, Tunisia, Turkey, United Arab Emirates, & United Kingdom.
  • Product Description
    Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems
  • Manufacturer
    Guidant Endovascular Solutions, Inc.

Manufacturer

Guidant Endovascular Solutions, Inc.
  • Manufacturer Address
    Guidant Endovascular Solutions, Inc., 26531 Ynez Rd, Temecula CA 92591-4630
  • Source
    USFDA