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MiniMed 780G Insulin Pump MMT-1894MD

by Medtronic Minimed, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

6 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00199150047055 UDI-DI Date8 Nov 2025ListedStatusListed GUDID: in commercial distribution

Recalls

6 recalls · 6 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2982-2026 FDA Class II initiated 13 Jul 2026
    • Ongoing Z-2980-2026 FDA Class II initiated 13 Jul 2026

    Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.

    • Ongoing Z-2698-2026 FDA Class II initiated 27 May 2026

    A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23. Insulin delivery will stop which may lead to delayed therapy and an increased risk of hyperglycemia or diabetic ketoacidosis (DKA).

    • Ongoing Z-1741-2026 FDA Class II initiated 13 Feb 2026

    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.

    • Ongoing Z-1635-2026 FDA Class II initiated 30 Jan 2026

    Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery).

    • Ongoing Z-1238-2026 FDA Class II initiated 2 Nov 2025 on shared 510(k) K251032

    A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
MiniMed 780G Insulin Pump
Generic Name
Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
Model / Reference
MMT-1894MD
Primary DI / UDI-DI
00199150047055
510(k) Number
FDA Product Code
NDC, QFG
GMDN Term
Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
Device Class
Class II
Regulation Number
868.1890, 880.5730
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K251032)

Other devices from Medtronic Minimed, Inc.

See all devices from Medtronic Minimed, Inc. →

Properties

  • Prescription Use
  • Convenience Kit
  • Serial Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No