Medtronic MiniMed Paradigm REAL-Time Veo Insulin Pump Recall

Source: FDA · United States and Worldwide

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Medtronic MiniMed, Inc. is recalling 55,724 units of Paradigm REAL-Time Veo Insulin Pumps due to potential over- or under-delivery of insulin caused by gravitational forces.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 14, 2026 and geographically references United States and Worldwide. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, cpsc, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Medtronic MiniMed, Inc. is recalling certain insulin pumps because they may over-deliver or under-deliver insulin when the pump is elevated or lowered relative to the infusion site, due to changes in gravitational force affecting pressures. This issue can lead to severe health risks including hypoglycemia, hyperglycemia, seizure, coma, diabetic ketoacidosis, or death.

Which Products Are Affected

The affected products are the Paradigm REAL-Time Veo Insulin Pump with models MMT-554 and MMT-754. A total of 55,724 units are involved in this recall. Distribution occurred nationwide in the United States, including states such as OR, CA, AZ, NY, TX, FL, OH, MO, TN, NJ, NC, SC, IL, VA, WA, DC, GA, PA, MS, IA, MI, NH, OK, SD, MT, WI, WV, MA, LA, MN, RI, AR, ME, AL, IN, UT, KY, CO, ND, MD, CT, NM, KS, ID, NV, DE, NE, VT, AK, HI, WY, PR, VI, and worldwide in countries including Taiwan, Australia, Canada, and many others. The recall number is Z-1752-2026, and it was initiated on February 13, 2026.

What You Should Do

Consumers who have the affected pumps should follow the initial firm notification, which was issued via letter, and contact Medtronic MiniMed, Inc. for further instructions on the recall process, including potential returns or refunds.

Why This Matters

This recall addresses a serious safety issue with insulin delivery that could result in life-threatening conditions for users, highlighting the importance of proper medical device function in diabetes management.

Source

Attribution: FDA. For more information, visit the FDA website at the recall page for event ID 98186.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medtronic MiniMed, Inc. is recalling 55,724 units of Paradigm REAL-Time Veo Insulin Pumps due to potential over- or under-delivery of insulin caused by gravitational forces.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects United States and Worldwide. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.