FDA Medical Device Recalls (openFDA)
Guidant Endovascular Solutions, Inc.: Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems
- Recall number
- Z-1586-05
- Recalling firm
- Guidant Endovascular Solutions, Inc.
- Product
- Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems
- Status
- Terminated
- Initiated
- 2005-08-08
- Posted
- 2005-09-24
- Terminated
- 2012-07-31
- 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.
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K011039","K011506","K032530","K033834"]
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 2024168
- Firm city
- Temecula
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28