—#26511

Product

Boston Scientific/Microvasive Open End Ureteral Catheter (5 Fr x 70 cm) Product Number: 400-201

FDA product code: GBM — Catheter, Urethral
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K830840
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Boston Scientific Place, Natick, Massachusetts 01760

Distribution

Distribution pattern: Nationwide Foreign:Singapore, Japan, Korea, Canada, Africa

Timeline

Recall initiated: 2003-03-17
Posted by FDA: 2003-04-17
Terminated: 2016-03-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #26511. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.