FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Boston Scientific/Microvasive Open End Ureteral Catheter (6 Fr x 70 cm) Product Number: 400-202
- Recall number
- Z-0740-03
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific/Microvasive Open End Ureteral Catheter (6 Fr x 70 cm) Product Number: 400-202
- 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
- 72 boxes (20 units/box)
- Distribution
- Nationwide Foreign:Singapore, Japan, Korea, Canada, Africa
- Lot, serial or model codes
- Lot Numbers: 5161012 5174860 5174861 5180481 5185487 5218431 5221729 5243192 5243192 5252957 5296861 5296862 5303657 5327920 5327921 5327921 5345290 5348157 5355947
- 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