Tandem Diabetes Care is recalling 17,745 Tandem Mobi insulin pumps running specific software versions. A software error can cause the pump to display a 'Malfunction 12' alert, which falsely indicates a failure of the vibration motor. This malfunction causes the pump to stop operating entirely, halting all insulin delivery and communication with mobile apps.
When the pump stops operating, the user is no longer receiving programmed insulin doses, which can lead to dangerously high blood sugar levels (hyperglycemia). If not addressed quickly, severe hyperglycemia can result in serious medical complications.
You have 2 options:
Battery-operated infusion pump for basal and bolus insulin delivery.
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.
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.