Class II recallOngoing

MiniMed 780G Insulin Pump recall — FDA event 99207

FDA · FDA event 99207 · Posted Jul 8, 2026

Published Jul 8, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

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).

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

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

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists MiniMed 780G Insulin Pump by Medtronic MiniMed, Inc..

Products affected by FDA event 99207
Model	Description	Lot / serial range	Manufactured	Status
Z-2698-2026	Z-2698-2026	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	Not provided in the normalized record	Ongoing

Distribution: International distribution to the countries of Spain, Great Britain, Netherlands, Italy.
Units affected: See official FDA record
Category: Insulin pumps

Timeline

May 27, 2026
Recall initiated
Date recorded by the FDA.
Jul 8, 2026
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 99207
Published: Jul 8, 2026
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

Class II recallOngoing

iLet Bionic Pancreas recall — FDA event 98517

The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when the user successfully slides the unlock slider on the Lock Screen, no screen transition occurs,…

FDA · FDA event 98517Posted Jun 18, 2026

Class II recallOngoing

iLet Bionic Pancreas recall — FDA event 98475

insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin…

FDA · FDA event 98475Posted Apr 29, 2026

Class II recallOngoing

iLet Ace Pump Kit recall — FDA event 98528

it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those…

FDA · FDA event 98528Posted Apr 10, 2026

Loading MedWatcher information…

MiniMed 780G Insulin Pump recall — FDA event 99207

FDA · FDA event 99207 · Posted Jul 8, 2026

Published Jul 8, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Affected products and models

This FDA record lists MiniMed 780G Insulin Pump by Medtronic MiniMed, Inc..

Products affected by FDA event 99207
Model	Description	Lot / serial range	Manufactured	Status
Z-2698-2026	Z-2698-2026	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	Not provided in the normalized record	Ongoing

Distribution

International distribution to the countries of Spain, Great Britain, Netherlands, Italy.

Units affected

See official FDA record

MiniMed 780G Insulin Pump recall — FDA event 99207

Follow MiniMed 780G Insulin Pump

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

MiniMed 780G Insulin Pump recall — FDA event 99207

Follow MiniMed 780G Insulin Pump

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline