—#26512

Product

Boston Scientific/Microvasive Open End Ureteral Catheter (6 Fr x 70 cm) Product Number: 400-202

FDA product code: GBM — Catheter, Urethral
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K830840
Affected lot / code info: Lot Numbers: 5161012 5174860 5174861 5180481 5185487 5218431 5221729 5243192 5243192 5252957 5296861 5296862 5303657 5327920 5327921 5327921 5345290 5348157 5355947

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 #26512. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.