| 2026-01-30 |
Class II
|
Ongoing |
Z-1636-2026 |
Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize … |
— |
The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infu… |
| 2025-10-06 |
Class I
|
Ongoing |
Z-0427-2026 |
Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both… |
— |
Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due … |
| 2025-08-05 |
Class II
|
Ongoing |
Z-0232-2026 |
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, a… |
— |
A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technolo… |
| 2025-07-21 |
Class I
|
Ongoing |
Z-2343-2025 |
Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacemen… |
— |
Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become i… |
| 2025-07-03 |
Class II
|
Ongoing |
Z-2621-2025 |
t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app) |
— |
an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing issues and graphical defects, which can potentially… |
| 2025-02-27 |
Class I
|
Ongoing |
Z-1520-2025 |
Tandem Mobi Insulin Pump with Interoperable Technology |
— |
A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to … |
| 2025-02-27 |
Class I
|
Ongoing |
Z-1519-2025 |
t:slim X2 Insulin Pump with Interoperable Technology |
— |
A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to … |
| 2024-03-05 |
Class I
|
Ongoing |
Z-1609-2024 |
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology |
— |
During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which le… |
| 2022-05-24 |
Class II
|
Ongoing |
Z-1812-2022 |
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim … |
— |
Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, … |
| 2022-05-24 |
Class II
|
Ongoing |
Z-1811-2022 |
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim … |
— |
Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, … |
| 2020-09-10 |
Class II
|
Ongoing |
Z-1258-2022 |
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology |
— |
Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the batte… |