Tandem Mobi Android App Correction: Extended Bolus Immediate Dose May Be Omitted
Manually maintained record
An editor supplied or changed this record. These edits have not been verified by the agency. Last edited: 2026-11-13T03:59:22.988Z. No official verification is recorded.
Reported risk
When the entered glucose value equals the active target, the Now portion of an Extended Bolus is incorrectly reduced to zero. The Later portion is delivered, but total insulin may be lower than intended without a distinct alert, potentially causing unrecognized under-delivery and hyperglycemia. FDA Class II; injury counts not disclosed.
What should I do if I have this product?
Android users: do not use Extended Bolus. Standard Bolus and other available functions may still be used. Share the notice with caregivers and acknowledge receipt using the notification link or QR code. This is not an instruction to stop using the pump. Correction emailed October 13, 2026.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
The product description and identifiers below were supplied or edited by a person. Confirm them with the agency notice or the firm before relying on a match; missing information does not establish that your product is unaffected.
Which lot codes, UPCs or models are affected?
FDA Event 100091; Z-0437-2027. UDI-DI 00389152547244. Android software versions 3.5.4, 3.5.2.2 and 3.5.2.1.
- Agency record number
- Z-0437-2027
- Affected products
- Tandem Mobi Insulin Pump with Interoperable Technology, with Android Tandem Mobi Mobile app
- Company
- Tandem Diabetes Care, Inc.
- Quantity
- 4,086 users
- Distribution
- United States nationwide and Czech Republic
- Models
- 1015472
- Contact
- Not provided