Class II — Medtronic MiniMed, Inc.
| 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 | A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23. Insulin delivery will stop which may lead to delayed therapy and an increased risk of hyperglycemia or diabetic ketoacidosis (DKA). |
| Product | MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896 |
| Quantity | 778 |
| Distribution | International distribution to the countries of Spain, Great Britain, Netherlands, Italy. |
| Initiated | 2026-05-27 |
| Classified | 2026-07-08 |
| Recall number | Z-2698-2026 |
| 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, Inc. (Z-2698-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99207/
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