Medtronic Minimed, Inc.
Medtronic Minimed, Inc. holds FDA 510(k) medical device clearances, first cleared 2007, most recent 2026, with 55 FDA device recalls on record.
Top product codes for Medtronic Minimed, Inc.
FDA recalls by Medtronic Minimed, Inc.
10 most recent of 55- Z-0203-2027 — CareLink Clinic, REF: MMT-7350
- Z-0265-2027 — Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (Android) Software Version: Software version 1.2.1 Product Description: The MiniMed Go app for iOS or MiniMed Go app for Android is compatible with the following components: " Simplera sensor " Instinct sensor " InPen smart insulin pen " Apple Watch [Optional] Continuous glucose monitoring (CGM) is a technology that allows you to continuously view glucose values. The app uses an inserted Simplera sensor CGM or Instinct sensor CGM with Bluetooth¿ wireless technology that converts small amounts of glucose from the interstitial fluid under the skin into an electronic signal. The sensors use that signal to provide sensor glucose (SG) values to the MiniMed Go app on a compatible mobile device. The app also provides alerts based on your SG levels and contains a user interface for entering data such as insulin, meals, exercise, blood glucose (BG) values, and uploading information to the CareLink" Personal website. The app is available to download from the Apple"* App Store"* or the Google Play"* Store. Component: No
- Z-0088-2027 — Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The MiniMed Flex pump is an alternate controller enabled (ACE) pump intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. It can reliably and securely communicate with compatible digitally connected devices, including an integrated continuous glucose monitor (iCGM), interoperable Medtronic continuous glucose monitor (CGM), and interoperable automated glycemic controller (iAGC). The pump is intended to be used in conjunction with compatible, digitally connected medical devices for the purpose of drug delivery. The primary user interface and primary display for the MiniMed Flex pump is the MiniMed app, also the user interface for the compatible MiniMed iAGCs, which runs on a compatible iOS or Android device.
- Z-2982-2026 — MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW
- Z-2981-2026 — MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
- Z-2980-2026 — MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;
- Z-2778-2026 — MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
- Z-2698-2026 — MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
- Z-1745-2026 — MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
- Z-1749-2026 — Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Medtronic Minimed, Inc.
- K253743 — MiniMed Flex pump
- K253470 — MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)
- K253585 — SmartGuard technology; Predictive Low Glucose technology
- K251217 — SmartGuard technology; Predictive Low Glucose technology
- K251032 — MiniMed 780G insulin pump
- K210714 — Extended Reservoir
- K151236 — MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)
- K070438 — MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305
Data sourced from openFDA. This site is unofficial and independent of the FDA.