TANDEM DIABETES CARE, INC.

Activity by year

Devices registered here (1)

• Continuous Glucose Monitor Secondary Display
  Product code PJT (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1350

Recalls & enforcement

• Class IIOngoing2026-01-30
  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 is connected to the body, when it should instead direct users to confirm that the infusion set is not connected…
• Class IOngoing2025-10-06
  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 software issue causing Malfunction 12: "Pump cannot operate, the mobile app can no longer receive data from the pum…
• Class IIOngoing2025-08-05
  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 are paired with a G7 sensor may result in an unexpected automatic insulin correction bolus (autobolus ) which co…
• Class IOngoing2025-07-21
  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 and stop infusing insulin which could result in a hyperglycemic event, which may lead to injury and/or hospita…
• Class IIOngoing2025-07-03
  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 incorrect therapy decisions and subsequent hypoglycemia or hyperglycemia.
• Class IOngoing2025-02-27
  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 incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of …
• Class IOngoing2024-03-05
  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 excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down so…
• Class IIOngoing2022-05-24
  Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, 4) Unexpected Open Loop, that can be mitigated with a software update. Issues could result in hypoglycemia, hyperglycemi…
• Class IIOngoing2020-09-10
  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 drops to less than 5%, insulin delivery will continue for 30 minutes and then the pump will power off and insuli…
• Class IIOngoing2018-04-23
  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: A) by triggering a Malfunction 4 Alarm, or B) by triggering a succession of notifications prior to the pum…
• Class ITerminated2014-01-10
  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 much or too little insulin, which can lead to a serious adverse event.

FDA inspections (4)

• VAI2023-03-23
  Voluntary Action Indicated · Compliance: Devices · citations posted
• VAI2021-10-15
  Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
• NAI2018-06-19
  No Action Indicated · Bioresearch Monitoring
• VAI2016-11-18
  Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Project Evaluation: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

• All facilities operated by Tandem Diabetes Care, Inc.
• Tandem Diabetes Care, INC. (CA)
• TANDEM DIABETES CARE, INC. (CA)
• TANDEM DIABETES CARE, INC. (CA)
• TANDEM DIABETES CARE, INC. (CA)
• Tandem Diabetes Care Europe B.V. (NL)

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)