Recall Z-1598-2010 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Ev3, Inc.
ev3 Protg EverFlex Self-Expanding Biliary Stent System, Sterile EO, (REF: PRB35-06-150-080, REF PRB35-06-120-120 and PRB35-06-150-120), 4.5 - 5.5mm, Expiration: 2011-10-01, Rx only. ev3 Inc., 4500 Nathan Lane North, Plymouth, MN 55442-2929. Intended as a palliative treatment of malignant neoplasms in the biliary tree.
| Date | May 13, 2010 (initiated Mar 31, 2010) |
| Status | Terminated |
| Reason | ev3 is conducting a voluntary recall on three lots of the Protg EverFlex" Biliary Stent System. They determined that a lot of 120mm Protg EverFlex" Biliary Stent system may contain a 150mm length Self-Expanding stent and two lots o 150mm Protg EverFlex" Biliary Stent System may contain a 120 mm length Self-Expanding stent. |
| Root cause | Mixed-up of materials/components |
| Action | ev3 issued "Medical Device Recall" notifications dated March 31, 2010 addressed to "Dear Risk Manager or Cath Lab Manager". Each letter addressed the affected product. Users were instructed to locate and remove from use the affected product and a sales representative will be in contact shortly to arrange for return. For further information, contact ev3 Customer Service at 1-800-716-6700. |
| Quantity | 19 |
| Distribution | Nationwide Distribution -- CA, FL, IL, LA, MA, MI, NH, PA, TN, TX, UT, VA and WA. |
| 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 |