Z-0789-03

Medtronic AVE brand BridgeAssurant Balloon Expandable Stent Delivery System for Biliary Catheter;Model #s...

Name: Z-0789-03 Medtronic AVE brand BridgeAssurant Balloon Expandable Stent Delivery System for Biliary Catheter;Model #s...
Creator: Medtronic Ave Inc
Published: 2003-02-27
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2003-02-27 / Terminated

FDA source

Medtronic Ave Inc began a recall of Medtronic AVE brand BridgeAssurant Balloon Expandable Stent Delivery System for Biliary Catheter;Model #s: FB720VF, FB730 VF, FB740 VF, FB760 VF, FB820VF... on 2003-02-27. The reason FDA records is "During use, device may exhibit high insertional resistance which may result in device damage, kinking and subsequent balloon deflation difficulties". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0789-03
Status: Terminated
Initiated: 2003-02-27
Posted: 2003-05-07
Terminated: 2003-09-22
Recalling firm: Medtronic, 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
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: During use, device may exhibit high insertional resistance which may result in device damage, kinking and subsequent balloon deflation difficulties.
FDA 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.
Product codes and lots: 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

Product code FGE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)