inforMED
MalfunctionDSP

Arrow FIBEROPTIX ULTRA 8 IAB SC: 8FR 50CC

Received Jul 29, 2026 · Event occurred Jul 4, 2026

Report 3010532612-2026-00851 · MDR key 50070249

Device

Generic name

System, Balloon, Intra-aortic

Catalog number

IAB-05850-LWS-SC

Lot number

18F26A0040

Product problems

  • Inflation Problem

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions