inforMED
MalfunctionJOH

Bivona Customized Tracheostomy Tubes

Received Jul 30, 2026 · Event occurred Jul 3, 2026

Report 2025816-2026-00072 · MDR key 50084236

Device

Generic name

Tube Tracheostomy And Tube Cuff

Manufacturer

Icu Medical, Inc.

Catalog number

SA25EN80ZTZ261N

Product problems

  • Inflation Problem

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions