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FDA Medical Device Recalls (openFDA)

Boston Scientific Corporation: Boston Scientific/Microvasive Cone Tip Ureteral Catheter (7 Fr x 70 cm) Product Number: 400-213

Recall number
Z-0739-03
Recalling firm
Boston Scientific Corporation
Product
Boston Scientific/Microvasive Cone Tip Ureteral Catheter (7 Fr x 70 cm) Product Number: 400-213
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
6 boxes (20 units/box)
Distribution
Nationwide Foreign:Singapore, Japan, Korea, Canada, Africa
Lot, serial or model codes
Lot Numbers: 5218586 5218586 5303655 5312172 5348155
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
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

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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

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