MiniMed FlexRecalls & reported problems across all models
Medtronic Minimed, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one MiniMed Flex model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of MiniMed Flex by Medtronic Minimed, Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
MiniMed Flex recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 20, 2026Open, Classified
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.
Z-0088-2027 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
MiniMed Flex models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MiniMed Flex MMT-8062Alternate controller enabled insulin infusion pump1 recall0 reports
- MiniMed Flex MMT-8072Alternate controller enabled insulin infusion pump1 recall0 reports
Other Medtronic Minimed, Inc. products
- MiniMed 670G23 models · 141,169 reports · 4 recalls
- MiniMed 630G23 models · 65,972 reports · 6 recalls
- Paradigm REAL-Time Revel180 models · 49,838 reports · 2 recalls
- MiniMed 530G71 models · 48,745 reports · 1 recall
- MiniMed670G2 models · 28,871 reports · 3 recalls
- MiniMed630G2 models · 6,656 reports · 5 recalls
- MiniMed Reservoir6 models · 4,545 reports
- PARADIGM REAL-time95 models · 2,862 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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