MalfunctionDSP
Sensation Plus 8Fr. 50cc IAB with Accessories, US Only
Received Jul 30, 2026 · Event occurred Jul 9, 2026
Report 2248146-2026-0001344 · MDR key 50079529
Device
Generic name
System, Balloon, Intra-aortic And Control
Manufacturer
Datascope Corp.Model number
0684-00-0576-01UCatalog number
0684-00-0576-01U
Lot number
3000511517
Product problems
- Deflation Problem
- Difficult to Insert
Patient
74 YR · Male
- No Clinical Signs, Symptoms or Conditions