ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010568.
FDA device recall Z-1085-06 · posted 2006-06-07 · Terminated
Recall details
- Recalling firm
- Guidant Endovascular Solutions, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- Approximately 38,203 units (all part #s) distributed US
- Distribution
- Nationwide
- Date initiated
- 2006-03-22
- Date posted
- 2006-06-07
- Date terminated
- 2012-08-13
- 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 |
|---|---|---|
| ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM (K033393) | Guidant Corp. | 2003-11-10 |