inforMED
MalfunctionLIT

FORTREX 0.035 OTW PTA BALLOON CATHETER

Received Jul 22, 2026 · Event occurred Jun 29, 2026

Report 2183870-2026-00334 · MDR key 25902734

Device

Generic name

Catheter, Angioplasty, Peripheral, Translumina

Manufacturer

Covidien

Catalog number

A35HPV05040080

Lot number

C185274

Product problems

  • Burst Container or Vessel
  • Leak/Splash

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions