inforMED
MalfunctionFGE

NaviFlex? RX Delivery System

Received Jul 28, 2026 · Event occurred Apr 29, 2026

Report 3005099803-2026-03062 · MDR key 50057608

Device

Generic name

Catheter, Biliary, Diagnostic

Model number

M00533580

Catalog number

M00533580

Lot number

0038019809

Product problems

  • Break
  • Entrapment of Device
  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions