Z-1586-05

Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems

Name: Z-1586-05 Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems
Creator: Guidant Endovascular Solutions, Inc.
Published: 2005-08-08
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2005-08-08 / Terminated

FDA source

Guidant Endovascular Solutions, Inc. began a recall of Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems on 2005-08-08. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1586-05
Status: Terminated
Initiated: 2005-08-08
Posted: 2005-09-24
Terminated: 2012-07-31
Recalling firm: Abbott Vascular
Product: Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: 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.
FDA root cause: Other
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.
Quantity in commerce: 69,700
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 codes and lots: 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 code FGE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)