Recall of Medtronic MiniMed Paradigm REAL-Time Insulin Pumps

Source: FDA · United States

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 29,074 Paradigm REAL-Time Insulin Pumps due to potential over- and under-delivery of insulin caused by gravitational forces, which could lead to severe health risks.

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. 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, fda, 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.

Recall Article

What Happened

Medtronic MiniMed, Inc. is recalling its infusion pumps, including the Paradigm series, because they may cause unintended over- or under-delivery of insulin due to changes in gravitational force affecting pressures, potentially resulting in severe hypoglycemia, altered mental status, seizure, coma, or death.

Which Products Are Affected

The affected products are the Paradigm REAL-Time Insulin Pump models MMT-522 and MMT-722. The recall involves 29,074 units distributed worldwide, including US nationwide in 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, and VI, as well as various countries. Specific code information includes UDI-DI (GTIN) numbers like 00613994409423 and others listed in the recall details, with the recall number Z-1749-2026.

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 voluntary recall.

Why This Matters

This recall addresses a critical safety issue with medical devices that could lead to serious health complications, emphasizing the importance of proper insulin delivery for patients managing diabetes.

Source

FDA recall notice with event ID 98186, available at FDA.gov under recall number Z-1749-2026.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medtronic MiniMed, Inc. is recalling 29,074 Paradigm REAL-Time Insulin Pumps due to potential over- and under-delivery of insulin caused by gravitational forces, which could lead to severe health risks.
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. 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.