Device Recall BridgeAssurant

Specific lots of 7 and 8 mm in diameter:  2E16E06, 2F05E10, 2F11E12, 2E15E01, 2F20E13, 2H06E02, V432C25E12, V432D04E14, 2D16E09, 2D29E08, 2E06E09, 2E28E15, 2G11E01, 2G10E01, 2H01E07, 2H15E06, 2K17E02, 2E21E01, 2H29E08, 2K24E02, V432D1E12, 2D12E12, 2D17E13, 2E10E13, 2E22E20, 2E24E10, 2E30E01, 2G15E01, 2G26E01, 2G24E10, 2K03E01, 2K17E01, 2L11E09, 2D30E02, 2E13E14, 2E21E14, 2E28E16, 2H19E18, 2L13E01, 2E07E13, 2E18E01, 2K23E02, 2E21E12, 2H06E03, V432C23E01, V432C29E11, 2D08E14, V432D05E12, 2D25E10, 2E16E16, 2G18E02, 2G26E23, 2H09E08, 2H14E05, 2K11E14, 2L07E06, 2E24E01, 2G24E11, 2H28E22, 2L08E04, V432C28E12, V432D02E09, 2D15E24, 2D24E13, 2E01E10, 2D18E12, 2E1415, 2E21E15, 2F24E13, 2G11E11, 2G17E01, 2G22E13, 2G26E01, 2H16E09, 2K15E03, 2K21E06, 2K21E05, 2L13E02, 2D24E12, 2D26E09, 2E15E25, 2F04E12, 2F18E13, 2H15E05, 2H21E10, 2J03E11, 2K03E07

Gastroenterology-Urology Devices

2

Yes

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.

Medtronic AVE brand Bridge¿Assurant¿ 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