Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems
FDA device recall Z-1586-05 · posted 2005-09-24 · Terminated
Recall details
- Recalling firm
- Guidant Endovascular Solutions, Inc.
- 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.
- Action taken
- (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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 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, Mex
- Date initiated
- 2005-08-08
- Date posted
- 2005-09-24
- Date terminated
- 2012-07-31
- Location
- Temecula, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OMNILINK .018 BILIARY STENT SYSTEM (K033834) | Guidant Corp. | 2004-01-02 |
| MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM (K032530) | Guidant Corporation | 2003-10-23 |
| OMNILINK .035 BILIARY STENT SYSTEM (K011506) | Guidant Corp. | 2001-06-15 |
| OMNILINK .018 BILIARY STENT SYSTEM (K011039) | Guidant Corp. | 2001-05-08 |