FDA-Device2026-10-14Class IIPROCESSING DEFECT

Medtronic MiniMed Flex insulin pump recalled for failed quality verification tests

OTHERNationwide distributionMedical devices

What this means

Some MiniMed Flex insulin pumps were shipped without completing required quality verification tests. These pumps may have problems including failure to work at startup, moisture damage, slow charging, connection issues with glucose monitors or the app, missed occlusion alerts, weak alarm sounds, or inaccurate insulin delivery.

Check if your pump's serial number matches the affected list (MMT-8072 or MMT-8062 models).
Contact Medtronic immediately if your pump is affected — do not rely on it without guidance from your provider.
Work with your healthcare team to arrange a replacement or alternative pump.

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The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

U.S. Nationwide distribution in the states of AR, AZ, CO, FL, KS, KY, LA, MI, MN, NJ, NY, OH, PA, SD, TN, TX, and WV.

Affected count

Manufactured in

18000 Devonshire St, N/A, Northridge, CA, United States

Products

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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0088-2027

More Medtronic recalls

FDA-Device2026-08-26
Medtronic MiniMed 640G insulin pump loaner units recalled for potential malfunction from incompatible cleaning
FDA-Device2026-08-26
Medtronic MiniMed 670G insulin pump loaner units recalled for damage risk and insulin delivery failure
FDA-Device2026-08-26
Medtronic MiniMed 780G insulin pump loaner units recalled for potential moisture damage and insulin delivery failure
FDA-Device2026-07-29
Medtronic MiniMed Go App recalled for missed insulin alerts at night

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