inforMED
MalfunctionDSP

Arrow FIBEROPTIX ULTRA 8 IAB SC: 8FR 50CC

Received Jul 27, 2026 · Event occurred Jun 25, 2026

Report 3010532612-2026-00811 · MDR key 50009388

Device

Generic name

System, Balloon, Intra-aortic

Catalog number

IAB-05850-LWS-SC

Lot number

18F26A0039

Product problems

  • Increase in Pressure

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions