Boston Scientific/Microvasive Open End Ureteral Catheter (4 Fr x 70 cm) Product Number: 400-200
FDA Recall Z-0734-03 · Posted 2003-04-17
Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeGBM
Date Initiated2003-03-17
Date Terminated2016-03-07
Product Quantity12 boxes (20 units/box)
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
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide Foreign:Singapore, Japan, Korea, Canada, Africa
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.