FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0789-03
- Recalling firm
- Medtronic Ave Inc
- Product
- 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
- Status
- Terminated
- Initiated
- 2003-02-27
- Posted
- 2003-05-07
- Terminated
- 2003-09-22
- 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.
- Quantity
- not on file
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 3001452571
- Firm city
- Santa Rosa
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28