Recall Z-1083-06 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Guidant Endovascular Solutions, Inc.
Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010566.
| Date | Jun 7, 2006 (initiated Mar 22, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | Identify all customers who have been shipped affected product 2) Deliver Physician Medical Device Recall Notice and Reconciliation Form via Federal Express 3) Guidant field representatives contact hospitals by phone and in person to reinforce letter and recall plan4) Reconcile receipt notifications and physical product returns to expected returns. |
| Quantity | Approximately 38,203 units (all part #s) distributed US |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033393 | ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM Guidant Corp., Nov 10, 2003 |