inforMED
MalfunctionLZG

Omnipod DASH Insulin Management System

Received Jul 28, 2026 · Event occurred May 2, 2026

Report 3014585508-2026-50358 · MDR key 50051406

Device

Generic name

Pump, Infusion, Insulin

Model number

18320

Catalog number

BLE-I1-529

Lot number

PD1U11152411

Product problems

  • Fluid/Blood Leak

Patient

Female

  • Hyperglycemia

Remedial action

  • Recall