Guidant Endovascular Solutions, Inc. Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

(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.