MalfunctionDSP
Arrow RediGuard IAB: 8Fr 40cc
Received Jul 27, 2026 · Event occurred Nov 21, 2025
Report 3010532612-2026-00820 · MDR key 50011583
Device
Generic name
System, Balloon, Intra-aortic
Manufacturer
Arrow International LlcCatalog number
IAB-S840C
Lot number
18F25C0104
Product problems
- Material Rupture
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
QN# (b)(4).n/a.Other Remarks: n/a.Corrected Data: n/a.