United StatesWhat's being recalled
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…
Recalling firm: Medtronic MiniMed, Inc., Northridge, CA, United States.
How to identify it
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).
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)