Recall Z-0642-2009 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Medtronic Cardiovascular
Medtronic COMPLETE SE Self Expanding Biliary Stent System, Model number SC760L, includes a pre-loaded self-expanding Nickel-Titanium (Nitinol) stent with 8 tantalum radiopaque markers, 4 on each end, and an over the wire retractable sheath delivery system.
| Date | Mar 18, 2009 (initiated Nov 24, 2008) |
| Status | Terminated |
| Reason | Mislabeled: Product may contain wrong instructions for use-- may contain International IFU instead of the correct US (for Biliary indication use only) IFU. |
| Root cause | Process control |
| Action | Medtronic sent a notification entitled "URGENT - VOLUNTARY MEDICAL DEVICE RECALL" to consignees on 11/21/2008. All products are to be returned to the firm's distribution center. For further information, please contact Medtronic Cardiovascular by telephone at 707-566-0111. |
| Quantity | 23 units |
| Distribution | Nationally in the states of NY, TX, CA, IA, AZ, PA, IN, and KS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062264 | COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM Medtronic Vascular, Nov 8, 2007 |