Recall of Medtronic MiniMed Paradigm REAL-Time 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 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 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.
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 ↗
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 (1,512 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to April 14, 2026.
Frequently Asked Questions
Common questions about this FDA recall.