Recall Z-1802-2010 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Medtronic CardioVascular
Medtronic Racer Biliary Stent System, Model number XD518YF, UPC code 00721902758164 in a box containing sterilized pouch with product, manufactured by Medtronic Vascular, Sunnyvale, CA. Medical device system consisting of a balloon-expandable intraluminal stent premounted onto the balloon of an over the wire delivery catheter. The system as two radiopaque markers on the inner member and positione
| Date | Jun 14, 2010 (initiated Jul 30, 2009) |
| Status | Terminated |
| Reason | Mislabeling-- The incorrect Instructions for use may have been included with this product. |
| Root cause | Mixed-up of materials/components |
| Action | The firm, Medtronic, Inc., sent an "URGENT- VOLUNTARY MEDICAL DEVICE RECALL" dated July 30, 2009, to custumers (Sales Representatives, to health care provider, patient, and risk manager, hospital administrator). The letter describes the product, problem and the action to be taken by the customers. The customers were instructed to immediately segregate any Racer Biliary units from model number XD518YF (L#0000705315) in their possession to prevent inadvertent use. Medtronic, Inc., representative will contact the customer to review the labeling and retrieve the device should it be in their inv |
| Quantity | 13 |
| Distribution | Worldwide distribution: USA and Greater China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032768 | MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L) Medtronic Ave, Inc., Oct 9, 2003 |