Medtronic MiniMed 640G Insulin Pump Recall

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 116,645 units of MiniMed 640G Insulin Pumps due to potential over- and under-delivery of insulin from 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 15, 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

The recall is due to unintended over- and under-delivery of insulin in Medtronic MiniMed infusion pumps when the pump is elevated or lowered relative to the infusion site, caused by changes in gravitational force impacting pressures.

Which Products Are Affected

The affected products are MiniMed 640G Insulin Pumps with model numbers MMT-1711, MMT-1712, MMT-1751, and MMT-1752. A total of 116,645 units are involved, with distribution 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, VI, and countries worldwide. The recall number is Z-1743-2026, and code information includes various UDI-DI/GTIN numbers such as 643169999763, 763000002763, and others listed in the source.

What You Should Do

Consumers should follow the initial firm notification, which was sent via letter, and contact the recalling firm, Medtronic MiniMed, Inc., at their address: 18000 Devonshire St, Northridge, CA 91325-1219, for information on returns or refunds related to this voluntary recall.

Why This Matters

This recall affects a large number of insulin pumps worldwide, potentially leading to serious health risks such as severe hypoglycemia, seizures, coma, or death from over-delivery, and severe hyperglycemia or diabetic ketoacidosis from under-delivery.

Source

FDA Recall Notice: Event ID 98186

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 116,645 units of MiniMed 640G Insulin Pumps due to potential over- and under-delivery of insulin from 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.