FDA Medical Device Recalls (openFDA)
Medtronic MiniMed, Inc.: MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
- Recall number
- Z-2698-2026
- Recalling firm
- Medtronic MiniMed, Inc.
- Product
- MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
- Status
- Open, Classified
- Initiated
- 2026-05-27
- Posted
- 2026-07-08
- Terminated
- not on file
- 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).
- Root cause
- Software design
- Action
- 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
- Quantity
- 778
- Distribution
- International distribution to the countries of Spain, Great Britain, Netherlands, Italy.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K251032"]
- PMA numbers
- not on file
- Product code
- QFG
- Firm FEI
- 3003166194
- Firm city
- Northridge
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28