inforMED
MalfunctionDSP

Sensation Plus 8Fr. 50cc IAB with Accessories, US Only

Received Jul 27, 2026 · Event occurred Jul 2, 2026

Report 2248146-2026-0001324 · MDR key 50032180

Device

Generic name

System, Balloon, Intra-aortic And Control

Manufacturer

Datascope Corp.

Model number

0684-00-0576-01U

Catalog number

0684-00-0576-01U

Lot number

3000518873

Product problems

  • Unraveled Material
  • Failure to Advance

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions