Safety alerts

25 MAY 2026 – UPDATED URGENT – PRODUCT CORRECTION

MiniMed Mobile App (Android version) App/Pump Disconnection Issue

TGA Reference: RC-2026-RN-00381-1

ARTG: 408370

Dear Valued Customer:

Medtronic is contacting you regarding MiniMed Mobile App Android software version 3.2.0. We identified a problem where the app disconnects from the pump. This email provides instructions on how to correct the problem by updating your MiniMed Mobile App to the latest version 3.2.1 or higher, if you have not already done so.

Customer Action Required:

• Users of MiniMed Mobile App Android software version 3.2.0 should update to version 3.2.1 or higher as soon as possible to resolve this problem if they have not already done so. Please click on the link below to download the new version of the app.
  https://play.google.com/store/apps/details?id=com.medtronic.diabetes.minimedmobile.eu

To confirm the latest app version on your Android device, follow the steps below.

• Open the Google Play Store app.
• Tap Menu and then Manage apps & devices.
• Apps with an update available are labeled "Update available.” You can also search for a specific app.
• Tap Update.

Regardless of if your MiniMed Mobile App version is affected, please acknowledge that you have read and understood this notification and have followed the actions listed in this notification by using the button below.

Problem Description:

For MiniMed Mobile App Android version 3.2.0, the following problems were identified.

• Disconnection between the MiniMed Mobile Android app and the pump, with a "Pump Communication Error" message displayed. Pump data and alerts are not displayed in the MiniMed Mobile Android app version 3.2.0.
• Subsequent pairing attempts between the MiniMed Mobile Android app and the pump fail.
• Periodic data from the pump fails to upload to CareLink, and the latest data is not included if attempting to generate a CareLink report.
• If you have a linked care partner using the CareLink Connect app (MMT-6111/MMT-6112), the care partner will not receive active notifications, but will receive a displayed notification after 15 minutes that no new data is being sent from the followed MiniMed Mobile Android App user.

Risk to Health:

This issue may result in inconvenience for impacted MiniMed Mobile App Android version 3.2.0 users, as the MiniMed Mobile App cannot be used as a secondary display and users must rely on the primary pump display. However, the insulin pump and Continuous Glucose Monitoring (CGM) functionality are not affected.

In addition, this problem can result in HCPs not having the most recent data in CareLink report, and care partners not receiving data in the CareLink Connect app. Per the MiniMed Mobile and CareLink Connect Apps’ Instructions for Use (IFU), dosing decisions should not be made based on information in the applications, and therapy decisions should always be made following instructions on the insulin pump or CGM system.

Additional Information

Medtronic is initiating this action in consultation with the Therapeutic Goods Administration.

Local Contact Details

As always, we are here to support you and ensure we deliver the highest quality products possible. If you have further questions or need assistance, please call the Medtronic 24-Hour Technical Support line at 1-800-777 808.

Sincerely,

Lewis Hong
Sr Post Market Vigilance Specialist | Quality and Regulatory Affairs

Medtronic
Medtronic Australasia Pty Ltd
Level 8, 11 Khartoum Road | Macquarie Park, NSW, 2113 | Australia
lewis.l.hong@medtronic.com
medtronic.com.au | Facebook | LinkedIn | Twitter | YouTube

April 2026 – UPDATED URGENT – PRODUCT CORRECTION

Pump Delivery Volume Accuracy (DVA) during Changes in Air Pressure

TGA Reference: RC-2025-RN-00061-1

ARTG: 308140 / 332201 / 376091 / 484825 / 484826

Dear Valued Customer:

Medtronic is contacting you about an update to the Urgent Product Correction regarding your MiniMed™ insulin pump. During quality testing performed by Medtronic, we recently found that changes in air pressure can cause unintended insulin delivery. For example, air pressure in an airplane can change rapidly during flight, which may cause expansion of tiny air bubbles inside the insulin reservoir.

The update is to highlight 02 new ARTG numbers.

Problem Description:

• When air pressure decreases (e.g., during flight takeoff), more insulin may be released than expected. Additionally, unintended insulin may be released even if the pump’s delivery is suspended or programmed to zero units per hour.
• When air pressure increases (e.g., during flight landing), less insulin may be released than expected.

Risk to Health:

The changing air pressure conditions could result in more insulin being delivered during flight takeoff, potentially leading to hypoglycemia, or less insulin being delivered during flight landing, potentially leading to hyperglycemia.

Between July 2003 and May 2024, Medtronic received 138 complaints potentially related to this problem, 19 of which reported serious injuries, but none were confirmed to be related to this problem. It is important to monitor your glucose frequently while flying and be prepared to treat hypoglycemia or hyperglycemia. Individuals with lower daily insulin doses and those with high insulin sensitivity may experience greater changes in glucose during changes in air pressure than individuals with higher insulin doses and/or lower insulin sensitivity. If you are unsure as to whether this applies to you, it is important that you seek your healthcare professional’s treatment guidance.

Recommended Actions for Pump Users:

1. Monitor Your Glucose Levels: Check your glucose frequently during activities like air travel, amusement park rides, or other situations where sudden changes or extremes of air pressure, altitude, or gravity may occur.
2. Discuss how to prepare for situations like this with your healthcare professional. Keep an emergency kit with rapid-acting glucose and backup insulin therapy available at all times.
3. Respond to Alerts and Symptoms: Pay attention to any alerts from your pump as well as symptoms of hypoglycemia or hyperglycemia. Follow your healthcare professional's treatment instructions in these situations.

Please acknowledge that you have read and understood this notification and have followed the actions listed in this letter by scanning the QR code below with your contact details.

Additional Information

Medtronic is initiating this action in consultation with the Therapeutic Goods Administration.

Local Contact Details

As always, we are here to support you and ensure we are delivering the highest quality products possible. If you have further questions or need assistance, please call the Medtronic 24-Hour Technical Support line at 1800-777 808.

March 2026 – URGENT – PRODUCT DEFECT CORRECTION

MiniMed™ Paradigm™, 600 series, and 700 series insulin pump systems

Pump Placement with Respect to Infusion Site

TGA Reference: RC-2026-RN-00154-1

ARTG: 95763, 308140, 332201, 376091, 484825, 484826

Products impacted:
MiniMed™ Paradigm™ Insulin Pumps (all models)
MiniMed™ 640G, 670G, 770G, 780G Insulin Pumps (all models)

Dear Valued Customer:

We are contacting you with guidance about how to position your pump and infusion set. Please note that this issue and the required actions apply to all MiniMed™ Paradigm™, MiniMed™ 600 Series, and MiniMed™ 700 Series pump models.

Problem Description:

• Due to environmental conditions, there may be slight variability in the amount of insulin delivered when your pump is worn at distances above or below the location of your infusion set.
• This variability may increase with increasing distances above or below your infusion set location.
• Placing the pump above your infusion site can cause over-delivery and placing it below your infusion site can cause under-delivery.
• The greatest variability in insulin delivery may occur at distances beyond 35.5 cm above or below your infusion set location.
• This variability in insulin delivery will not be captured in your pump’s history or CareLink reports.

Customer Action Required:

• Keep the location of your insulin pump close to your infusion site.
• If you need to raise the pump above your infusion site, such as when a parent or caregiver is using the pump for a child, limit the time that the pump is held above the infusion site.
• Pay attention to any alerts from your pump as well as symptoms of hypoglycemia and hyperglycemia; follow your healthcare professional's treatment instructions in these situations.
• If you have any concerns about how this may impact insulin delivery and blood glucose, please contact your healthcare professional. You may also contact the Medtronic 24-Hour Technical Support line at 1-800-777 808 with any questions about this notification.
• Please keep a copy of this notice with the Instructions for Use for your pump.

Please acknowledge that you have read and understood this notification and have followed the actions listed in this letter by scanning the QR code below with your phone or tablet, to acknowledge this communication.

Risk to Health:

• Individuals who require lower daily insulin doses and those with high insulin sensitivity may experience changes to their blood sugar (hypoglycemia or hyperglycemia) because of this phenomenon.
• If you are unsure whether this applies to you, it is important that you seek guidance from your healthcare professional.

As of February 9, 2026, Medtronic has not identified any user complaints that can be attributed to this problem.

Medtronic Actions or Further Information:

Medtronic MiniMed will update the User Guides for our currently distributed insulin pumps to include the following:

"It is important to keep the location of your pump stable relative to your infusion site. Do not wear or place your pump more than 14 in (35.5 cm) above your infusion site. Doing so can cause an over-delivery of insulin, which may result in hypoglycemia."

Additional Information:

Medtronic is initiating this action in consultation with the Therapeutic Goods Administration.

Local Contact Details:

As always, we are here to support you and ensure we deliver the highest quality products possible. If you have further questions or need assistance, please call the Medtronic 24-Hour Technical Support line at 1-800-777 808.

June 2025 - URGENT FIELD SAFETY NOTICE

InPen™ App - Reminder Settings Notification Issue

TGA Reference: RC-2025-RN-00562-1

ARTG: 485045

Dear Valued Customer:

Medtronic is contacting you regarding InPen App software versions 7.0.0, 7.0.1, 7.1.0, 7.1.1, 7.2.0, and 7.5.0. During in-house testing, we identified a problem where certain reminder settings may prevent notifications from being delivered as expected. This email provides instructions on how to correct the problem by updating your InPen App to the latest version, if you have not already done so. This letter contains instructions on you can check your InPen app software version. If you are not running one of the affected versions, no action is required.

Problem Description:

For InPen App versions 7.0.0, 7.0.1, 7.1.0, 7.1.1, 7.2.0, and 7.5.0, the following problems were identified which affect notifications from triggering as expected:

• Nighttime Schedule After Midnight: If the Nighttime schedule is set to start after midnight (12:00 AM) and Nighttime notifications are disabled, then Daytime (AM) notifications fail to trigger.
• 12:00 AM Reset Issue: If Daytime or Nighttime is set to start at 12:00 AM, after navigating to the settings screen or force-closing the app, the app resets the default Breakfast or Nighttime start times to 12:00AM.
  Start Time Adjustments: Adjusting the Breakfast start time automatically updates the Daytime start time to match the new Breakfast start time

Risk to Health:

• If notifications fail to trigger due to these issues, and rapid-acting insulin doses—which help prevent blood glucose spikes after meals—are missed without checking InPen app or Medtronic CGM app data, it may lead to delayed therapy and an increased risk of hyperglycemia.
• To date, no complaints have been reported related to this issue.

Actions Required:

Users of InPen app software versions 7.0.0, 7.0.1, 7.1.0, 7.1.1, 7.2.0 and 7.5.0 should update to version 7.5.1 or higher as soon as possible to resolve this problem if they have not already done so.

For iOS Users

1. Verify your app version:
   
   • On the home screen, navigate to the Settings menu (upper left corner).
   • Select Help and Support.
   • Note the App Version displayed.
2. If you are running versions 7.0.0, 7.1.0, 7.2.0, or 7.5.0, update to the latest version (7.5.1 or higher) via the App Store:
   
   • Open the App Store.
   • Tap your profile icon at the top of the screen.
   • Scroll to see pending updates.
   • Tap Update next to the InPen app icon.

For Android Users

1. Verify your app version:
   
   • On the home screen, navigate to the Settings menu (lower right corner).
   • Select Help and Support.
   • Note the App Version displayed.
2. If you are running versions 7.0.0, 7.0.1, 7.1.0, 7.1.1, 7.2.0, or 7.5.0, update to the latest version (7.5.1 or higher) via the Google Play Store:
   
   • Open the Google Play Store.
   • Tap your profile icon at the top of the screen, then select Manage apps & device.
   • Tap Updates available or search for the InPen app.
   • Tap Update next to the InPen app icon.

Regardless if your InPen app is affected, please acknowledge that you have read and understood this notification and have followed the actions listed in this notification by clicking the I understand and Acknowledge button below:

Additional Information

Medtronic is initiating this action in consultation with the Therapeutic Goods Administration.

Local Contact Details

We are committed to patient safety and welcome any questions you may have regarding this communication. Please do not hesitate to contact the Medtronic 24-Hour Technical Support line at 1800 777 808.

February 2025 - URGENT – PRODUCT DEFECT CORRECTION

Pump Delivery Volume Accuracy (DVA) during Changes in Air Pressure

TGA Reference: RC-2025-RN-00061-1

ARTG: 308140 / 332201 / 376091

Dear Valued Customer:

Medtronic is contacting you about an Urgent Medical Device Correction regarding your MiniMed™ insulin pump. During quality testing performed by Medtronic, we recently found that changes in air pressure can cause unintended insulin delivery. For example, air pressure in an airplane can change rapidly during flight, which may cause expansion of tiny air bubbles inside the insulin reservoir.

Problem Description:

• When air pressure decreases (e.g., during flight takeoff), more insulin may be released than expected. Additionally, unintended insulin may be released even if the pump’s delivery is suspended or programmed to zero units per hour.
• When air pressure increases (e.g., during flight landing), less insulin may be released than expected.

Risk to Health:

The changing air pressure conditions could result in more insulin being delivered during flight takeoff, potentially leading to hypoglycemia, or less insulin being delivered during flight landing, potentially leading to hyperglycemia.

Between July 2003 and May 2024, Medtronic received 138 complaints potentially related to this problem, 19 of which reported serious injuries, but none were confirmed to be related to this problem. It is important to monitor your glucose frequently while flying and be prepared to treat hypoglycemia or hyperglycemia. Individuals with lower daily insulin doses and those with high insulin sensitivity may experience greater changes in glucose during changes in air pressure than individuals with higher insulin doses and/or lower insulin sensitivity. If you are unsure as to whether this applies to you, it is important that you seek your healthcare professional’s treatment guidance.

Recommended Actions for Pump Users:

1. Monitor Your Glucose Levels: Check your glucose frequently during activities like air travel, amusement park rides, or other situations where sudden changes or extremes of air pressure, altitude, or gravity may occur.
2. Discuss how to prepare for situations like this with your healthcare professional. Keep an emergency kit with rapid-acting glucose and backup insulin therapy available at all times.
3. Respond to Alerts and Symptoms: Pay attention to any alerts from your pump as well as symptoms of hypoglycemia or hyperglycemia. Follow your healthcare professional's treatment instructions in these situations.

Please acknowledge that you have read and understood this notification and have followed the actions listed in this letter by scanning the QR code below with your contact details.

Additional Information

Medtronic is initiating this action in consultation with the Therapeutic Goods Administration.

Local Contact Details

As always, we are here to support you and ensure we are delivering the highest quality products possible. If you have further questions or need assistance, please call the Medtronic 24-Hour Technical Support line at 1800-777 808.