FDA Device recall Z-1750-2026
Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
- FDA Device
- Class II
- ongoing
- Published 2026-04-08
On 2026-04-08 the FDA classified a Class II recall of Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723) by Medtronic Minimed, citing all Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1750-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-13 |
| Published | 2026-04-08 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medtronic Minimed |
| Distribution | US |
Product
Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
Reason
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Identifiers
| code_info | Pump: UDI-DI(GTIN): User Guide Name(Part-Version): Paradigm Real-Time Revel Insulin Pump: 00613994951502, 007630001612…Pump: UDI-DI(GTIN): User Guide Name(Part-Version): Paradigm Real-Time Revel Insulin Pump: 00613994951502, 00763000161262, 00613994743930, 00643169077737, 00613994904485, 00643169202399, 00643169151369, 00643169478602, 00643169513914, 00643169933170, 00763000161132, 00643169464520: Artwork, CRB D Process, Paradigm REAL-Time Revel Insulin Pump UG (MP6025306-011A 1); Artwork, CRB D Process, Instr, X23 revel, EN (MP6025306-019 1) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1750-2026%22
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