- 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).
- Affected products (lot / model / serial)
- UDI-DI/GTIN: A7630006392701, 00763000521554, 00763000639273, A7630006392301, 00199150035687, A7630007325603, A7630007325601, 00763000639235, A7630007325604, 00763000384289, 00763000521530, A7630007325401, 00763000521547, A7630006392601, A7630006392201, 00763000639228, 00199150035663, 00763000639266, A7630007325404, 00199150035694, 00763000442194, A7630007325403, 00763000521523. Software version 6.62
- Units affected
- 778
- Distribution pattern
- International distribution to the countries of Spain, Great Britain, Netherlands, Italy.
- Firm location
- Northridge, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- N/A
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2698-2026
- Recall initiated
- May 27, 2026
- FDA classification date
- July 8, 2026
- FDA report date
- July 15, 2026
- FDA event ID
- 99207
- Last updated on HTM Vibe
- July 23, 2026