Recall of Medtronic Paradigm Insulin Pumps
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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 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.
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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 ↗
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