MalfunctionDSP

Arrow FiberOptix Ultra 8 IAB: 8Fr 40cc

Received Jul 29, 2026 · Event occurred Jul 2, 2026

Report 3010532612-2026-00834 · MDR key 50069725

Device

Generic name

System, Balloon, Intra-aortic

Manufacturer

Arrow International Llc

Catalog number

IAB-05840-LWS

Product problems

Leak/Splash

Patient

Unknown

No Clinical Signs, Symptoms or Conditions