Class II recallOngoing

Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Descr recall — FDA event 99818

FDA · FDA event 99818 · FDA posted Oct 5, 2026

Published by MedWatcher Oct 28, 2026Record source last checked: 2026-10-28 03:25:03 UTC

What happened

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.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

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.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Descr by Medtronic MiniMed, Inc..

Products affected by FDA event 99818
Model	Description	Lot / serial range	Manufactured	Status
Z-0088-2027	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.	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).	Not provided in the normalized record	Ongoing

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.
Units affected: See official FDA record
Category: Insulin pumps

Timeline

Aug 20, 2026
Recall initiated
Date recorded by the FDA.
Oct 5, 2026
Posted by FDA
The recall event appeared in the FDA source.
Oct 28, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 99818
Published: Oct 5, 2026
Source checked: 2026-10-28 03:25:03 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

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Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Descr recall — FDA event 99818

FDA · FDA event 99818 · FDA posted Oct 5, 2026

Published by MedWatcher Oct 28, 2026Record source last checked: 2026-10-28 03:25:03 UTC

What happened

Affected products and models

This FDA record lists Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Descr by Medtronic MiniMed, Inc..

Products affected by FDA event 99818
Model	Description	Lot / serial range	Manufactured	Status
Z-0088-2027	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.	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).	Not provided in the normalized record	Ongoing

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.

Units affected

See official FDA record

Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS soft recall — FDA event 99589

FDA · FDA event 99589Posted Sep 29, 2026

Class II recallOngoing

MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712; recall — FDA event 99374

FDA · FDA event 99374Posted Aug 18, 2026

Class II recallOngoing

MiniMed 780G Insulin Pump recall — FDA event 99207

FDA · FDA event 99207Posted Jul 8, 2026

Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Descr recall — FDA event 99818

Follow Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Descr

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Descr recall — FDA event 99818

Follow Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Descr

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline