Recall of Medtronic Paradigm 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 73,656 Paradigm 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 15, 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 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, cpsc, Devices.
Recall of Medtronic Paradigm Insulin Pumps
What Happened
Medtronic MiniMed, Inc. is recalling its infusion pumps, including the Paradigm series, because they may unintentionally over-deliver or under-deliver insulin when the pump is elevated or lowered relative to the infusion site due to changes in gravitational force.
Which Products Are Affected
The affected products are the Paradigm Insulin Pump models MMT-712 and MMT-715. A total of 73,656 units are involved, with distribution 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 internationally in countries like Taiwan, Canada, and the United Kingdom. Specific codes include UDI-DI numbers such as 643169999770 and 763000069001.
What You Should Do
Consumers with affected pumps should follow the instructions in the letter from Medtronic MiniMed, Inc., as this is a voluntary recall initiated by the firm.
Why This Matters
This recall involves potential risks of severe hypoglycemia or hyperglycemia, which could lead to serious health issues or death, affecting a significant number of users who rely on these devices for insulin delivery.
Source
FDA Recall Notice: Z-1748-2026
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 (1,382 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.