Reported Oct 14, 2026 · Ongoing · Updated Oct 20, 2026
Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product…
Medtronic MiniMed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic MiniMed, Inc. · 18000 Devonshire St · Northridge, CA · 91325-1219
Is this the product you have?
- Brand NameMiniMed
- Flex Product NameMiniMed
- Flex Insulin Pump Model/Catalog NumbersMMT-8062
- MMT-8072 Product DescriptionThe 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
- Lot codes and dates
- MMT-8072 Lot CodeSerial
- numbers
FB00015839FB00016511FB00014455FB00011553FB00015700FB00011357FB00019307FB00014766FB00014822FB00015828FB00018580FB00010465FB00014472FB00015793FB00015794FB00015796FB00015799FB00015801FB00015977FB00017271
- UDI-DI/GTIN00763000848156
- NoteInitially 25 pumps were identified as put into service, however 2 were shipped to Marketing Team Members and recovered. 3 Pumps were returned through complaint process. Final total of pumps available in the field is 20
- MMT-8062 Lot CodeSerial
- numbers
FB00011770FB00015162FB00016429FB00014760
- FB00015797 UDI-DI/GTIN00763000848149 (Serial
- NumbersFB00017271, FB00011770, FB00015162, FB00016429, FB00014760 were returned via complaint process or shipped to Marketing Team Members)
- Amount recalled
- 25
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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