inforMED
MalfunctionOWQ

COLABEL

Received Jul 20, 2026 · Event occurred Jun 25, 2026

Report 3032391-2026-00061 · MDR key 25881121

Device

Generic name

Eagle Eye Plat St Digital Ivus 5fx15

Manufacturer

Medline Renewal

Catalog number

85900PSTRH

Lot number

571140

Product problems

  • Component Incompatible

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions