FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Boston Scientific/Microvasive Open End Ureteral Catheter (5 Fr x 70 cm) Product Number: 400-201
- Recall number
- Z-0735-03
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific/Microvasive Open End Ureteral Catheter (5 Fr x 70 cm) Product Number: 400-201
- Status
- Terminated
- Initiated
- 2003-03-17
- Posted
- 2003-04-17
- Terminated
- 2016-03-07
- Reason
- Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use
- 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
- 293 boxes (20 units/box)
- Distribution
- Nationwide Foreign:Singapore, Japan, Korea, Canada, Africa
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K830840"]
- PMA numbers
- not on file
- Product code
- GBM
- Firm FEI
- 3001451463
- Firm city
- Natick
- Firm state
- MA
- 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