Recall Z-0478-2010 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Ev3, Inc.
Protg EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6 x 150mm, Model # PRB35-06-150-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, MN 55442-2920, Rx only. Protg EverFlex" Self-Expanding Peripheral Stent System (for Outside United States distribution). 6 x 100mm, Model Number PRP35-06-100-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, M
| Date | Dec 1, 2009 (initiated Nov 6, 2009) |
| Status | Terminated |
| Reason | ev3 has determined that a lot of 150mm Protg EverFlex Biliary Stent System contains a 100mm length Self-Expanding stent. The implantation of a stent 50mm shorter than expected may not cover the full length of the target lesion and may require subsequent intervention. |
| Root cause | Labeling mix-ups |
| Action | Two separate letters were sent to United States and international consignees on November 9, 2009. The letter to US consignees was addressed to Cath Lab Managers while the letter to foreign consignees was addressed to the Risk Manager or Cath Lab Manager. The letters described the affected product, gave an Issue Summary and Required Action, which advised consignees to locate and remove the recalled product. An Ev3, Inc. sales representative will contact consignees to arrange return of all unused product to Ev3, Inc. Direct questions regarding the recall to Ev3, Inc. by calling Customer Serv |
| Quantity | 6 (United States) and 6 (Outside United States) |
| Distribution | Worldwide Distribution -- United States (TX and FL), GERMANY, FRANCE and UNITED KINGDOM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060057 | PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM Ev3, Inc., Mar 8, 2006 |