Recall Z-0088-2027
- Recall number
- Z-0088-2027
- Event number
- 99818
- Firm
- Medtronic MiniMed, Inc.
- Firm FEI
- 3003166194
- Product code
- QFG
- Status
- Open, Classified
- Initiated
- 2026-08-20
- Posted
- 2026-10-05
- Root cause
- Under Investigation by firm
- 510(k) numbers
- K253743, K223213, K230545, K253074, K261672, K231485, K260001, K213134, K223846, K250930, K233044, K232380, K201214, K253470, K250792, K231826, K253976, K203234, K213536, K251032, K241078, K191679, K234027, K233952, K241178, K240309, K203768, K252770
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.
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.