Z-0735-03

Boston Scientific/Microvasive Open End Ureteral Catheter (5 Fr x 70 cm) Product Number: 400-201

Name: Z-0735-03 Boston Scientific/Microvasive Open End Ureteral Catheter (5 Fr x 70 cm) Product Number: 400-201
Creator: Boston Scientific Corporation
Published: 2003-03-17
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2003-03-17 / Terminated

FDA source

Boston Scientific Corporation began a recall of Boston Scientific/Microvasive Open End Ureteral Catheter (5 Fr x 70 cm) Product Number: 400-201 on 2003-03-17. The reason FDA records is "Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0735-03
Status: Terminated
Initiated: 2003-03-17
Posted: 2003-04-17
Terminated: 2016-03-07
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific/Microvasive Open End Ureteral Catheter (5 Fr x 70 cm) Product Number: 400-201
Product code: GBM Catheter, Urethral
Reason for recall: Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use
FDA root cause: Other
Action: Boston Scientific/Microvasive, Natick, MA notified domestic accounts by letter on 3/17/03. Users are requesed to check inventory and return product to Boston Scientific. A responsed form was requested to be completed. and returned by facsmile.
Quantity in commerce: 293 boxes (20 units/box)
Distribution: Nationwide Foreign:Singapore, Japan, Korea, Canada, Africa
Product codes and lots: Lot Numbers: 5178078 5180218 5195624 5198454 5202074 5205547 5208877 5215596 5218848 5225787 5228124 5229087 5230642 5238639 5241768 5243189 5243189 5243190 5246163 5252047 5252048 5252049 5253538 5256810 5259786 5269989 5291570 5303658 5315933 5315934 5326181 5326182 5327127 5331373 5334828 5337025 5337026 5337026 5344010 5345288 5355951 5358877

Product code GBM

K830840Class IIOpen Ended Ureteral CatheterVan-Tec, Inc. / cleared 1983-04-06

Hollister recalls 2.5 million intermittent catheters over a manufacturing defect11 SEP 2026 / by Medical Device Manufacturing

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)