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MiniMed Extended Supply Kit MMT-445B

by Medtronic, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

7 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 Number00199150084050 UDI-DI Date19 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

7 recalls · 7 ongoing · FDA

    • Ongoing Z-0088-2027 FDA Class II initiated 20 Aug 2026

    Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9 functional tests. The unverified/failed pumps released to users potentially have one or more of the following issues: inoperable pump at setup, lack of protection for moisture exposure, slow battery charging, disconnection issues with other system components (i.e., continuous glucose monitoring sensor or MiniMed mobile app), reduced ability to detect occlusion events, compromised audio for pump alarms/alerts, and/or inaccurate insulin delivery.

  • 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 Extended Supply Kit
Generic Name
Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
Model / Reference
MMT-445B
Primary DI / UDI-DI
00199150084050
510(k) Number
FDA Product Code
QFG
GMDN Term
Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
Device Class
Class II
Regulation Number
880.5730
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K251032)

Cleared under the same submission (K253743)

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Sterile
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number

Other properties (10)

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