inforMED
MalfunctionDSP

Sensation Plus 7.5Fr. 40cc IAB with Accessories, US Only

Received Jul 27, 2026 · Event occurred Jul 5, 2026

Report 2248146-2026-0001321 · MDR key 50016772

Device

Generic name

System, Balloon, Intra-aortic And Control

Manufacturer

Datascope Corp.

Model number

0684-00-0568-01U

Catalog number

0684-00-0568-01U

Lot number

3000526761

Product problems

  • Leak/Splash
  • Obstruction of Flow

Patient

60 YR · Male

  • No Clinical Signs, Symptoms or Conditions