Class II — Medtronic MiniMed
| Recalling firm | Medtronic |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery. |
| Product | Medtronic MiniMed Paradigm Insulin pump, model number MMT-712E |
| Quantity | 36,143 |
| Distribution | US nationwide distribution including Puerto Rico. |
| Initiated | 2019-06-27 |
| Classified | 2020-03-26 |
| Recall number | Z-1585-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Medtronic MiniMed (Z-1585-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83433/
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