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Ongoing FDAEvent 99818 (9 days ago)

Medtronic MiniMed Flex Insulin Pumps

The MiniMed Flex insulin pump may have failed verification tests, leading to issues such as inaccurate insulin delivery.

Moderate risk

Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.

FDA Class II recall · How risk is rated

What to do

What happened

Medtronic MiniMed, Inc. recalled the MiniMed Flex Insulin Pump (models MMT-8062 and MMT-8072) on August 20, 2026, because some pumps were released with missing or failed verification test results in one or more of 9 functional tests. The unverified or failed pumps may have issues such as an inoperable pump at setup, which could affect insulin delivery. The FDA added the recall to its Enforcement Report and classified it on October 5, 2026.

Summary by Recall Canary from the FDA notice.

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Affected if its model number is listed.

  1. MiniMed Flex Insulin Pump

    Model
    • MMT-8062
    • MMT-8072

Details

Company began the recall
Event ID
99818
Company
Medtronic MiniMed, Inc.
  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

All recalls from Medtronic MiniMed, Inc.

Summary by Recall Canary, written with AI · summary updated Oct 6, 2026 · primary source: U.S. Food and Drug Administration