Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 35574 |
| Brand Name: | Tandem t:slim X2 insulin pump with Basal-IQ |
| Model: | Tandem t:slim X2 Pump with Basal IQ Technology |
| Affected: | |
| Software version: | |
| Recalling Organisation: | New Zealand Medical & Scientific Ltd Level 4, Building 10 666 Great South Road Ellerslie AUCKLAND 1051 |
| Contact Information: | 09 259 4062 |
| Manufacturer: | Tandem Diabetes Care Inc |
| Brand Name: | Tandem t:slim X2 insulin pump with CIQ/CIQ+ |
| Model: | Tandem t:slim X2 Pump with Control IQ Technology |
| Affected: | |
| Software version: | |
| Recalling Organisation: | New Zealand Medical & Scientific Ltd Level 4, Building 10 666 Great South Road Ellerslie AUCKLAND 1051 |
| Contact Information: | 09 259 4062 |
| Manufacturer: | Tandem Diabetes Care Inc |
| Issue: | 20/7/26: Update - Software version 7.10.4 is now available and should be downloaded to the pump. This software update is intended to enhance early detection of speaker failure and introduces persistent vibration alerts to help reduce potential safety risk. The manufacturer has identified certain speaker versions that have a higher rate of Malfunction 16 events due to a wiring problem within the speaker. If a Malfunction 16 is declared on the pump, insulin delivery will stop, and the pump is no longer operational. A Malfunction 16 will stop insulin delivery and terminate communication between the insulin pump and the CGM device, as well as the Tandem t:slim mobile app. If not addressed, this could result in hyperglycaemia due to the malfunction resulting in the stoppage of insulin delivery and real time CGM Estimated Glucose Values (EGVs) and CGM trends. In severe cases of hyperglycaemia, the user may require hospitalisation or intervention from a medical professional. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Public Recall |
| Date Commenced: | 20/7/2026 |
