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Guidant Endovascular Solutions, Inc.

Country not established

Devices
1
FDA recalls
7

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Guidant Endovascular Solutions, Inc. makes

Guidant Endovascular Solutions, Inc. manufactures the OMNILINK 018 Biliary Stent System, a biliary stent designed for use in the biliary tree to relieve obstructions.

The OMNILINK 018 Biliary Stent System is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

FDA recalls7

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 7 recalls initiated by Guidant Endovascular Solutions, Inc., the earliest on 2005-08-08 and the most recent on 2006-03-22. By recorded status: 7 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2006

    • 22 Mar 2006 Z-1080-06 Unclassified (pre-2012) Terminated Design : increasing number of customer complaints with a trend of stent deployment difficulties. The difficulties are reported during acute deployment of the stent, therefore patients in whom a stent has successfully been implanted are not affected by this action. Distribution: Nationwide Submission number: K033393
    • 22 Mar 2006 Z-1081-06 Unclassified (pre-2012) Terminated Design : increasing number of customer complaints with a trend of stent deployment difficulties. The difficulties are reported during acute deployment of the stent, therefore patients in whom a stent has successfully been implanted are not affected by this action. Distribution: Nationwide
    • 22 Mar 2006 Z-1082-06 Unclassified (pre-2012) Terminated Design : increasing number of customer complaints with a trend of stent deployment difficulties. The difficulties are reported during acute deployment of the stent, therefore patients in whom a stent has successfully been implanted are not affected by this action. Distribution: Nationwide Submission number: K033393
    • 22 Mar 2006 Z-1083-06 Unclassified (pre-2012) Terminated Design : increasing number of customer complaints with a trend of stent deployment difficulties. The difficulties are reported during acute deployment of the stent, therefore patients in whom a stent has successfully been implanted are not affected by this action. Distribution: Nationwide Submission number: K033393
    • 22 Mar 2006 Z-1084-06 Unclassified (pre-2012) Terminated Design : increasing number of customer complaints with a trend of stent deployment difficulties. The difficulties are reported during acute deployment of the stent, therefore patients in whom a stent has successfully been implanted are not affected by this action. Distribution: Nationwide Submission number: K033393
    • 22 Mar 2006 Z-1085-06 Unclassified (pre-2012) Terminated Design : increasing number of customer complaints with a trend of stent deployment difficulties. The difficulties are reported during acute deployment of the stent, therefore patients in whom a stent has successfully been implanted are not affected by this action. Distribution: Nationwide Submission number: K033393

  • 2005

    • 8 Aug 2005 Z-1586-05 Unclassified (pre-2012) Terminated 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. Distribution: Nationwide and Argentina, Austria, Bahrain, Belgium, Brazil, Bulgaria, Chile, Czech Republic, Dominican Republic,…
      Full distribution text 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.
      Submission numbers: K011039, K011506, K032530, K033834

Frequently asked questions

How many devices does Guidant Endovascular Solutions, Inc. have in the registry?

The registry currently lists 1 device for Guidant Endovascular Solutions, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Guidant Endovascular Solutions, Inc.'s devices?

Among its 1 most recently registered device, Guidant Endovascular Solutions, Inc. has devices listed in FDA 510(k) (1 device).

What risk classes do Guidant Endovascular Solutions, Inc.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for Guidant Endovascular Solutions, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Guidant Endovascular Solutions, Inc.?

FDA recall records list 7 recalls initiated by Guidant Endovascular Solutions, Inc., the most recent initiated on 22 Mar 2006. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Guidant Endovascular Solutions, Inc. in the registry?

The most recently registered devices listed for Guidant Endovascular Solutions, Inc. include OMNILINK. 018 BILIARY STENT SYSTEM.

Generated automatically from registry data and not verified by a human reviewer.