Date Initiated by Firm | March 22, 2006 |
Date Posted | June 07, 2006 |
Recall Status1 |
Terminated 3 on August 13, 2012 |
Recall Number | Z-1085-06 |
Recall Event ID |
35099 |
510(K)Number | K033393 |
Product Classification |
Biliary Self-Expanding Stent System - Product Code FGE
|
Product | ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010568. |
Code Information |
All part numbers and all lot numbers of the 135 cm length delivery catheter are affected: 1) Base Part # FG1010568; Suffix (Stent Length, mm) = -20, -30, -40, -60, -80, -100. |
Recalling Firm/ Manufacturer |
Guidant Endovascular Solutions, Inc. 26531 Ynez Rd Temecula CA 92591-4630
|
For Additional Information Contact | Don Swanston 951-914-2774 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | Approximately 38,203 units (all part #s) distributed US |
Distribution | Nationwide |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = FGE
|