Z-0268-06

Bard UroForce Balloon Dilation Catheter with Glissando Coating * BARD * C.R. Bard, Inc. Covington, Georgia...

Name: Z-0268-06 Bard UroForce Balloon Dilation Catheter with Glissando Coating * BARD * C.R. Bard, Inc. Covington, Georgia...
Creator: C.R. Bard, Inc., Urological Division
Published: 2005-11-03
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2005-11-03 / Terminated

FDA source

C.R. Bard, Inc., Urological Division began a recall of Bard UroForce Balloon Dilation Catheter with Glissando Coating * BARD * C.R. Bard, Inc. Covington, Georgia 30014 * 1-800-526-4455 * Sterile/EO on 2005-11-03. The reason FDA records is "There is a potential for the lumen to collapse and prevent passage over a guidewire". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0268-06
Status: Terminated
Initiated: 2005-11-03
Posted: 2005-12-03
Terminated: 2006-01-24
Recalling firm: C.R. Bard Inc
Product: Bard UroForce Balloon Dilation Catheter with Glissando Coating * BARD * C.R. Bard, Inc. Covington, Georgia 30014 * 1-800-526-4455 * Sterile/EO
Product code: EZN Dilator, Catheter, Ureteral
Reason for recall: There is a potential for the lumen to collapse and prevent passage over a guidewire.
FDA root cause: Other
Action: Consignees were notified via overnight courier on 11/7&8/2005
Quantity in commerce: 480 units
Distribution: Nationwide, Belgium, Canada
Product codes and lots: Catalog #887504, Lot #GFPG2394; Catalog #887510, Lot #GFPG2399; Catalog #887604, GFPG2401, GFPG2402, GFPG2403, GFPG2404, GFPG2405, GFPG2424; Catalog #887610, Lot #GFPF3439, GFPG2406; Catalog #888404, Lot #GFPG2409, Catalog #888604, Lot #GFPG2411, GFPH1415; Catalog #888510, Lot #GFPG2415, GFPH2024; Catalog #888604, Lot #GFPG2417, GFPG2418; Catalog #888610, Lot #GFPF3451.

Product code EZN

K993840Class IIBard Uroforce Balloon Dilation CatheterC.R. Bard, Inc. / cleared 2000-01-31

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)