Recall Z-2023-2009 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Ev3, Inc.
ev3 The Endovascular Company, Protege GPS 6mm x 80mm Self Expanding Biliary Stent System, Rx Only, and SERB65-06-80-120. In the US, the intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the US, the intended for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions beli
| Date | Sep 8, 2009 (initiated Jun 10, 2009) |
| Status | Terminated |
| Reason | ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System because labeling did not match the actual stent size contained in the package. The affected product was labeled as a 6mm x 80mm Protege GPS stent but actually contained an 8mm x 40mm stent. This situation can lead to vessel damage or inadequate coverage of the target lesion. |
| Root cause | Labeling mix-ups |
| Action | Consignees were emailed a letter with a subject heading of "Medical Device Recall". The e-mail was dated June 10, 2009. The letter informed the consignee of the problem and product involved. They requested that any affected devices remaining in inventory be identified and returned and to fill out and return the "Device Recall Field Action Reconciliation Form". |
| Quantity | 5 |
| Distribution | International Distribution Only -- Brazil, Uruguay, & Malaysia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033314 | PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM Ev3, Inc., Nov 21, 2003 |