Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062;...
FDA Device Recall #Z-0088-2027 - Class II, August 20, 2026
Recall Summary
| Recall Number | Z-0088-2027 |
| Classification | Class II - Moderate risk |
| Date Initiated | August 20, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic MiniMed, Inc. |
| Location | Northridge, CA |
| Product Type | Devices |
| Quantity | 25 |
Product Description
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.
Reason for Recall
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.
Distribution Pattern
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.
Lot / Code Information
MMT-8072 Lot Code: Serial numbers: FB00015839, FB00016511, FB00014455, FB00011553, FB00015700, FB00011357, FB00019307, FB00014766, FB00014822, FB00015828, FB00018580, FB00010465, FB00014472, FB00015793, FB00015794, FB00015796, FB00015799, FB00015801, FB00015977, FB00017271. UDI-DI/GTIN: 00763000848156 Note: Initially 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 Code: Serial numbers: FB00011770, FB00015162, FB00016429, FB00014760, FB00015797 UDI-DI/GTIN: 00763000848149 (Serial Numbers: FB00017271, FB00011770, FB00015162, FB00016429, FB00014760 were returned via complaint process or shipped to Marketing Team Members).
Other Recalls from Medtronic MiniMed, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2982-2026 | Class II | MiniMed 780G Insulin Pump, Model: MMT-1885CLW, ... | Jul 13, 2026 |
| Z-2980-2026 | Class II | MiniMed 640G Insulin Pump, Model: MMT-1711, MMT... | Jul 13, 2026 |
| Z-2981-2026 | Class II | MiniMed 670G Insulin Pump, Model: MMT-1781, MMT... | Jul 13, 2026 |
| Z-2778-2026 | Class II | MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601... | Jun 16, 2026 |
| Z-2698-2026 | Class II | MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1... | May 27, 2026 |
Frequently Asked Questions
Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery, the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.