Medtronic MiniMed, Inc. — Class II: Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MM
Medtronic MiniMed, Inc. initiated a Class II recall for MiniMed Flex insulin pumps (Models MMT-8062 and MMT-8072) that were released to users despite missing or failed verification test results across nine functional areas. These unverified devices may exhibit issues ranging from inoperable setup and moisture protection failures to inaccurate insulin delivery and compromised alarm audio.
This recall affects Medtronic MiniMed, Inc., healthcare providers prescribing the MiniMed Flex system, and departments responsible for device manufacturing, quality control, and post-market safety monitoring of automated insulin delivery systems.
The release of devices with missing or failed verification results suggests a significant breakdown in manufacturing quality controls and release procedures. Because the MiniMed Flex is an alternate controller enabled (ACE) pump designed for interoperability with other digital health components, these functional failures—particularly in occlusion detection and dosing accuracy—represent a direct risk to patient safety and the integrity of the integrated glycemic control system.
QA teams should conduct a thorough audit of manufacturing release records to ensure all functional verification tests are documented with passing results. Regulatory and engineering leads should evaluate the impact of these specific failures on the risk management file, particularly regarding occlusion detection and dosing accuracy.
Class II. Reason: 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.. Product: 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.. Firm: Medtronic MiniMed, Inc. (Northridge CA United States). Status: Ongoing.
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