Recall Z-0789-03 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Medtronic Ave Inc
Medtronic AVE brand BridgeAssurant Balloon Expandable Stent Delivery System for Biliary Catheter;Model #s: FB720VF, FB730 VF, FB740 VF, FB760 VF, FB820VF, FB830VF, FB840VF, FB860VF; FB720VL, FB730VL, FB820VL, FB830VL; FB720F, FB730F, FB740F, FB760F, FB820F, FB830F, FB840F, FB860F; FB720L, FB730L, FB820L, FB830L
| Date | May 7, 2003 (initiated Feb 27, 2003) |
| Status | Terminated |
| Reason | During use, device may exhibit high insertional resistance which may result in device damage, kinking and subsequent balloon deflation difficulties. |
| Root cause | Other |
| Action | A letter was sent to each US commercial accounts via UPS overnight mailing on Saturday, March 1st, 2003 for delivery on Monday, March 3rd 2003. The notification instructs firm''s customers to sequester product from the specific lot numbers so that firm''s rep could assist in removing the affected product. |
| Distribution | Product was released for distribution to 446 consignees nationwide. The recall was appropriately extended to the user level; i.e., Clinics, hospitals and medical Centers who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.