MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
FDA device recall Z-2698-2026 · posted 2026-07-08 · Open, Classified
Recall details
- Recalling firm
- Medtronic MiniMed, Inc.
- Reason for recall
- 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).
- Action taken
- On 5/27/2026, field safety notices were emailed to customers who were asked to do the following: 1) Update insulin pump software to version 6.63. The update may take up to 3 hours to complete. 2) Reply to this email to confirm that you have read and understood this notification and, where applicable, completed the required action. If you have questions, contact the firm at 01923 205167
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- QFG
- Quantity affected
- 778
- Distribution
- International distribution to the countries of Spain, Great Britain, Netherlands, Italy.
- Date initiated
- 2026-05-27
- Date posted
- 2026-07-08
- Location
- Northridge, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MiniMed 780G insulin pump (K251032) | Medtronic Minimed, Inc. | 2025-07-01 |