inforMED
MalfunctionOWQ

N/A

Received Jul 30, 2026 · Event occurred Jul 7, 2026

Report 2134070-2026-00020 · MDR key 50092907

Device

Generic name

Reprocessed Intravascular Ultrasound Catheter

Manufacturer

Sterilmed, Inc.

Catalog number

R10439236

Lot number

2255204

Product problems

  • Tear, Rip or Hole in Device Packaging

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions