Recall Z-3330-2026 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
Tandem Diabetes Care, Inc.
Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS software version 2.13 UDI-DI: 00389152470740 Component: No
| Date | Sep 29, 2026 (initiated Jul 16, 2026) |
| Status | Open, Classified |
| Reason | A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P) continuous glucose monitoring (CGM) sensors, resulting in the insulin pump being unable to establish a near-field communication (NFC) connection with the CGM and requiring FSL3P users to use their t:slim insulin pumps in manual mode. FSL3P users are unable to access their CGM's glucose values from within the t:slim app and cannot use their pumps in automated control (closed-loop) mode, which coul |
| Root cause | Software Design Change |
| Action | On 07/16/2026, an "URGENT MEDICAL DEVICE CORRECTION" communication was sent via certified mail to customers informing them that an unexpected behavior was identified in the t:slim iOS mobile application version 2.13 made available through TestFlight. The issue involves users unable to pair a compatible FreeStyle Libre 3 Plus sensor after updating to version 2.13. If this occurs, the application will incorrectly display an "Incompatible Sensor" message and prevent sensor use. Customer are advised to: 1. Discontinue use of iOS t:slim mobile application version 2.13 2. Uninstall version 2.13 f |
| Quantity | 177 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201214 | t:slim X2 Insulin Pump with Interoperable Technology Tandem Diabetes Care, Inc., Jun 4, 2020 |
| K203234 | t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) Tandem Diabetes Care, Inc., Feb 15, 2022 |
| K232380 | t:slim X2 Insulin Pump with Interoperable Technology Tandem Diabetes Care, Inc., Nov 3, 2023 |