inforMED
MalfunctionDSP

Balloon Catheter

Received Jul 28, 2026 · Event occurred Jun 19, 2026

Report 2248146-2026-0001332 · MDR key 50050616

Device

Generic name

System, Balloon, Intra-aortic And Control

Manufacturer

Datascope Corp.

Product problems

  • Inability to Auto-Fill
  • Leak/Splash

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions