Tandem Diabetes Care, Inc. recalls
12 recalls in our records from 2014 to 2026: 12 FDA medical devices.
Recalls with full detail pages
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Tandem Diabetes Care, Inc. medical device recall: Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps…
Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a…
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Tandem Diabetes Care, Inc. medical device recall: Battery Operated infusion pumps. t:slim X2 G5
Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable…
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Tandem Diabetes Care, Inc. medical device recall: 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…
Earlier and other recalls
These link to the official agency notice.
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Tandem Diabetes Care, Inc. medical device recall: Brand Name: Tandem t:slim mobile application Product Name: t:slim… Official notice ↗
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…
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Tandem Diabetes Care, Inc. medical device recall: Tandem pumps are battery-operated infusion pumps capable of both… Official notice ↗
The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set…
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Tandem Diabetes Care, Inc. medical device recall: t:slim X2 insulin pump with Interoperable Technology Official notice ↗
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+ technology that…
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Tandem Diabetes Care, Inc. medical device recall: t:slim X2 Insulin Pump with Interoperable Technology Official notice ↗
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 lead to…
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Tandem Diabetes Care, Inc. medical device recall: t:connect mobile app used in conjunction with t:slim X2 insulin pump… Official notice ↗
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 leads to…
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Tandem Diabetes Care Inc medical device recall: t:slim X2 insulin pump Official notice ↗
Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, 4)…
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Tandem Diabetes Care Inc medical device recall: t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM Official notice ↗
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 battery life…
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Tandem Diabetes Care Inc medical device recall: t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version:… Official notice ↗
The fuel gauge, the component that reads and reports the battery parameters to the pump, could provide inaccurate readings, which present to the user in one of two ways:…
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Tandem Diabetes Care Inc medical device recall: T:slim Insulin Delivery System Insulin Infusion Pump Official notice ↗
Specific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for leaking. A cartridge leak could result in the device delivering too…
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.