—#26513

Product

Boston Scientific/Microvasive Open End Ureteral Catheter (7 Fr x 70 cm) Product Number: 400-203

FDA product code: GBM — Catheter, Urethral
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K830840
Affected lot / code info: Lot Numbers: 5225786 5303820 5312170 5340602

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 #26513. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.