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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Home Healthcare

Tandem Diabetes Care, Inc.: t:connect Mobile App Recalled for Battery Drain and Insulin Delivery Interruption

Agency Publication Date: May 6, 2024
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Summary

Tandem Diabetes Care is recalling approximately 85,863 t:connect mobile applications used with the t:slim X2 insulin pump. Version 2.7 of the app can crash and repeatedly restart on iOS devices, causing excessive Bluetooth communication that drains the pump's battery much faster than expected. If the pump battery dies, insulin delivery will stop, which can lead to serious health issues. This issue affects users nationwide who have installed version 2.7 or later of the application.

Risk

The rapid battery depletion can cause the insulin pump to shut down unexpectedly, suspending insulin delivery and potentially leading to hyperglycemia or severe life-threatening hyperglycemia.

What You Should Do

  1. Check your mobile device to see if you are using the t:connect mobile app version 2.7 or later with a t:slim X2 insulin pump with Control-IQ technology (UDI: 00850006613274).
  2. Monitor your pump battery level closely and ensure you have access to a backup insulin delivery method, such as a syringe and long-acting insulin, in case the pump shuts down.
  3. Immediately update your t:connect mobile app to the latest version available in the Apple App Store to resolve the battery drain issue.
  4. Contact your healthcare provider if you experience symptoms of hyperglycemia or have concerns about your insulin delivery.
  5. Contact Tandem Diabetes Care at 11075 Roselle St, San Diego, California, or via their official website for further instructions and technical support regarding this recall.
  6. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Software update and monitoring

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Model / REF:
UDI: 00850006613274
Lot Numbers:
version 2.7 or later

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94312
Status: Active
Manufacturer: Tandem Diabetes Care, Inc.
Sold By: Apple App Store; Tandem Diabetes Care
Manufactured In: United States
Units Affected: 85,863 applications
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 ยท FDA Press Release ยท 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.