Stop using now Medical device recall · FDA · Published August 20, 2026

MiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk

Medtronic recalls MiniMed Flex insulin pumps (MMT-8062/8072) due to failed verification tests that may cause inaccurate insulin delivery or device failure.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0088-2027Medical device MiniMed ›

Stop using this now

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.

✎ GovInfoNow plain-language explainer

Medtronic MiniMed is recalling the MiniMed Flex Insulin Pump because some units were released with missing or failed verification test results. These unverified pumps may suffer from issues such as inaccurate insulin delivery, inoperability at setup, or disconnection from other system components. The recall affects a very small number of devices distributed nationwide. Read more at govinfonow.com/recall/1629561-medtronic-minimed-inc-recalls-brand-name-minimed-flex-product-name.

Source Summary by GovInfoNow · govinfonow.com/recall/1629561-medtronic-minimed-inc-recalls-brand-name-minimed-flex-product-name · Published October 21, 2026 · Updated October 21, 2026 · FDA enforcement record: FDA #Z-0088-2027

Cite this page

“MiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk.” GovInfoNow, updated October 21, 2026. https://govinfonow.com/recall/1629561-medtronic-minimed-inc-recalls-brand-name-minimed-flex-product-name. Based on FDA recall #Z-0088-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0088-2027%22&limit=1).

The FDA announced on 2026-08-20 that Medtronic MiniMed, Inc. is recalling MiniMed Flex Insulin Pumps due to potential functional test failures. The agency stated the recall addresses risks of inaccurate insulin delivery and other device malfunctions.

How to tell if you have it

Brand: MiniMed
Product Name: MiniMed Flex Insulin Pump
Model/Catalog Numbers: MMT-8062; MMT-8072
MMT-8072 Serial numbers: FB00015839, FB00016511, FB00014455, FB00011553, FB00015700, FB00011357, FB00019307, FB00014766, FB00014822, FB00015828, FB00018580, FB00010465, FB00014472, FB00015793, FB00015794, FB00015796, FB00015799, FB00015801, FB00015977, FB00017271
MMT-8062 Serial numbers: FB00011770, FB00015162, FB00016429, FB00014760, FB00015797

The hazard

According to the FDA, some pumps were released with missing or failed verification test results. This potentially leads to issues such as inoperable pumps at setup, lack of moisture protection, slow battery charging, disconnection issues, reduced occlusion detection, compromised audio alarms, and inaccurate insulin delivery.

Context

GovInfoNow's records show Medtronic MiniMed, Inc. has 14 other recalls on record since 2023-11-15. Other recent recalls of similar products include Medtronic MiniMed 640G Insulin Pump Recall (2026-07-13), Medtronic MiniMed Go App Version 1.0.0/1.1.0 May Cause Missed Insulin Doses (2026-06-16), and Medtronic MiniMed 780G Insulin Pump Recall: Software Error Causes Insulin Stoppage (2026-05-27). Other recent recalls of similar products include ICU Medical Plum Duo IV Pump Recall (2026-04-29), Insulet Omnipod DASH Pod Recall (2026-05-20), and ICU Medical Plum Solo IV Pump Recall (2026-04-29).

How to tell if you have this one

Check if you have a MiniMed Flex Insulin Pump with model numbers MMT-8062 or MMT-8072. Look for the UDI-DI/GTIN 00763000848156 (for MMT-8072) or 00763000848149 (for MMT-8062). Specific serial numbers are listed in the record, including FB00015839, FB00016511, and others for MMT-8072, and FB00011770, FB00015162, etc. for MMT-8062.

Brand
MiniMed
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Your Pump Model
Verify if your device is a MiniMed Flex Insulin Pump with model number MMT-8062 or MMT-8072 and check the serial number against the recalled list.
Contact Medtronic
The record does not specify a remedy, return process, or contact information for this recall.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 17 states.

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, Arkansas, Colorado, Florida, Kansas, Kentucky, Louisiana, Michigan, Minnesota, New Jersey, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, West Virginia.

Recall timeline

FDA published this recall 55 days after the firm started it.

Aug 20, 2026Firm started the recall
Oct 5, 2026FDA classified it Class II
Oct 14, 2026Published in FDA’s Enforcement Report
Oct 21, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

How many pumps are being recalled?

A total of 25 pumps were identified, with 20 remaining in the field after some were recovered or returned.

Similar recalls

Other MiniMed recalls

Latest medical device recalls

Keep exploring

More MiniMed recalls

Link to this recall

<a href="https://govinfonow.com/recall/1629561-medtronic-minimed-inc-recalls-brand-name-minimed-flex-product-name">MiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0088-2027 (August 20, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0088-2027 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.