Recall of Medtronic Paradigm REAL-Time Revel Insulin Pumps
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 26,647 units of Paradigm REAL-Time Revel Insulin Pumps due to risks of unintended insulin over- or under-delivery from gravitational forces, potentially causing severe health issues.
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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Medtronic MiniMed, Inc. is recalling certain insulin pumps because they may cause unintended over- or under-delivery of insulin due to changes in gravitational force affecting pressures, which can lead to severe hypoglycemia, altered mental status, seizure, coma, or death from over-delivery, and severe hyperglycemia, dehydration, diabetic ketoacidosis, or death from under-delivery.
Which Products Are Affected
The affected products are the Paradigm REAL-Time Revel Insulin Pumps with models MMT-523 and MMT-723. A total of 26,647 units are involved, with distribution including US nationwide across 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 internationally in countries like Taiwan, Canada, and others. The recall number is Z-1750-2026, and specific codes include UDI-DI (GTIN) numbers such as 00613994951502.
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 instructions on the recall, including potential returns or refunds.
Why This Matters
This recall involves a significant number of insulin pumps used for diabetes management, potentially affecting thousands of users and posing serious health risks, emphasizing the need for reliable medical devices to prevent life-threatening complications.
Source
FDA recall notice: Attribution to FDA event ID 98186, reported on 20260408.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,629 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to April 15, 2026.
Frequently Asked Questions
Common questions about this FDA recall.