FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Boston Scientific/Microvasive Cone Tip Ureteral Catheter (5 Fr x 70 cm) Product Number: 400-211
- Recall number
- Z-0737-03
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific/Microvasive Cone Tip Ureteral Catheter (5 Fr x 70 cm) Product Number: 400-211
- 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
- 267 boxes (20 units/box)
- Distribution
- Nationwide Foreign:Singapore, Japan, Korea, Canada, Africa
- Lot, serial or model codes
- Lot Numbers: 5178119 5188905 5192526 5192527 5194308 5198455 5202075 5205549 5208875 5208878 5225910 5226327 5229088 5235251 5235252 5235253 5258360 5258361 5269990 5270281 5270281 5286299 5288682 5291571 5291572 5315936 5327922 5331374 5334829 5334830 5337023 5344015 5363071 5366442 5366443 5375808 5381688
- 510(k) numbers
- ["K870694"]
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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