Insulet Corporation: Omnipod 5 Automated Insulin Delivery System Recalled for App Connectivity Errors

Agency Publication Date: September 20, 2023

Summary

Insulet Corporation has recalled the Omnipod 5 App for certain Android smartphones affecting approximately 11,016 users. The recall was initiated because an error message prevented users from controlling their Omnipod 5 Automated Insulin Delivery System via the smartphone app, which could lead to a delay in insulin therapy. While 2,168 complaints and 9 Medical Device Reports were received, no serious injuries have been reported, and the Omnipod itself continues to deliver basal insulin according to pre-programmed settings even when the app is unavailable. Affected users are able to switch to the dedicated locked-down Controller provided with their system to manage their insulin during app disruptions.

Risk

A connectivity error between the smartphone app and the Insulet cloud can prevent users from commanding insulin boluses, potentially leading to high blood sugar due to a delay in therapy. Although the device continues to provide background (basal) insulin, the inability to deliver manual doses during meals or for corrections poses a moderate health risk.

What You Should Do

Identify if you use the Omnipod 5 App (PT-000559, UDI-DI: 10385081120302) on a compatible Android smartphone.
If you receive an error message on your smartphone app that prevents control of your insulin delivery, immediately switch to the dedicated, locked-down Omnipod 5 Controller that was provided to you when you first initiated the device.
Confirm that your Omnipod is still delivering basal insulin according to your pre-programmed settings; the Pod itself is not affected by this app error and will continue background delivery.
Always keep backup insulin supplies ready, such as insulin pens or syringes, as advised during your initial training, to ensure you can deliver insulin subcutaneously if both the app and controller are unavailable.
Contact Insulet Corporation or your healthcare provider for further instructions and to ensure your software is updated or your cloud connection is restored.
Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this recall.

Your Remedy Options

Other Action

Cloud-based certificate reversion and use of backup controller

How to: Affected users were advised to switch to the locked-down control provided to all users when they initiated the device. The manufacturer resolved the issue by reverting to prior certificates on the Insulet cloud.

Affected Products

Product: Omnipod 5 Automated Insulin Delivery System App

Model / REF:

PT-000559

UPC Codes:

10385081120302

Lot Numbers:

all versions of software installed

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92909

Status: Active

Manufacturer: Insulet Corporation

Sold By: Insulet Corporation

Manufactured In: United States

Units Affected: 11,016 users

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Identify if you use the Omnipod 5 App (PT-000559, UDI-DI: 10385081120302) on a compatible Android smartphone.

If you receive an error message on your smartphone app that prevents control of your insulin delivery, immediately switch to the dedicated, locked-down Omnipod 5 Controller that was provided to you when you first initiated the device.

Confirm that your Omnipod is still delivering basal insulin according to your pre-programmed settings; the Pod itself is not affected by this app error and will continue background delivery.

Always keep backup insulin supplies ready, such as insulin pens or syringes, as advised during your initial training, to ensure you can deliver insulin subcutaneously if both the app and controller are unavailable.

Contact Insulet Corporation or your healthcare provider for further instructions and to ensure your software is updated or your cloud connection is restored.

Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this recall.