Class 2 Device Recall MiniMed Flex

• Date Initiated by Firm: August 20, 2026
• Date Posted: October 05, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0088-2027
• Recall Event ID: 99818
• 510(K)Number: K253743
• Product Classification: Alternate controller enabled insulin infusion pump - Product Code QFG
• 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.
• 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).
• FEI Number: 3003166194
• Recalling Firm/ Manufacturer: Medtronic MiniMed, Inc.; 18000 Devonshire St; Northridge CA 91325-1219
• For Additional Information Contact: Ashley Patterson; 800-6464633
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: On 08/20/2026, Technical Support called affected customers to inform that, MiniMed identified an issue in which certain MiniMed Flex Insulin Pumps (MMT-8062) were released to customers with incomplete manufacturing testing. As a result of incomplete testing, your pump may have the potential for lack of protection from moisture exposure, slow charging, disconnection with sensor or MiniMed App, reduced ability to detect occlusion, no audio or low audio volume for alarms/alerts, or insulin under-delivery. If your pump experiences these issues, it could potentially lead to delayed therapy or risk of hypoglycemia, hyperglycemia, diabetic ketoacidosis (DKA) or death. For customers that were not able to be contacted via telephone call, an "URGENT MEDICAL DEVICE RECALL" Letter will be sent viaUSPS First-Class Mail. Customers are instructed to: 1. Stop using the Flex pump in their possession and revert to their back-up plan for insulin therapy. 2. Contact MiniMed immediately at (844) 885-0259 so arrangement can be made to ship customers a new Flex pump overnight. Upon calling, please say Flex when prompted to connect with an agent. 3. Please acknowledge that you ve read and understood this notification and have followed the actions listed by completing and returning the confirmation form, scanning the QR code below with your phone or tablet, or by visiting [https://www.minimed.com/en-us/safety-notices/notice33-letter] to acknowledge communication. For Questions or assistance - call the MiniMed 24-Hour Technical Support line at 1-800-646-4633, option 1.
• Quantity in Commerce: 25
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = QFG