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Tandem Diabetes Care, Inc.

United States·US-MF-000031791

Last updated September 17, 2026

Information

Country: United States
Address: 12400 High Bluff Drive, San Diego, United States
Website: tandemdiabetes.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 877-801-6901
PRRC Contact: —
EUDAMED SRN: US-MF-000031791
FDA FEI Number: 3013756811
DUNS Number: 827900809

Catalogue (150)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
Tandem t:slim AutoSoft XC Kit	1017083	FDA UDI	Class II	Active
t:slim X2 Cartridge, t:lock, 2 Pack	1000728	FDA UDI	Class III	Active
t:flex Insulin Pump, Replacement, Refurbished	007473	FDA UDI	Class II	Active
Tandem t:slimTruSteel Kit	1017101	FDA UDI	Class II	Active
t:slim Insulin Pump, Demonstration	007445	FDA UDI	Class II	Active
t:slim X2 Insulin Pump with Control-IQ	1009643	FDA UDI	Class II	Active
Tandem Mobi Autosoft 30 Kit	1014121	FDA UDI	Class II	Active
t:slim X2 Insulin Pump with Basal-IQ	1009640	FDA UDI	Class II	Active
t:flex Cartridge 2 Pack	007689	FDA UDI	Class II	Active
t:slim Cartridge 10 Pack	003380	FDA UDI	Class II	Active
t:slim X2 Insulin Pump with Basal-IQ	1006373	FDA UDI	Class II	Active
t:slim X2 Insulin Pump with Control-IQ	1005011	FDA UDI	Class II	Active
Tandem Mobi Autosoft 30 Kit	1013121	FDA UDI	Class II	Active
t:slim G4 Cartridge 2 Pack	007527	FDA UDI	Class III	Active
t:slim Cartridge, t:lock, 2 Pack	1000992	FDA UDI	Class II	Active
t:slim Insulin Pump	007435	FDA UDI	Class II	Active
t:slim Cartridge, t:lock, 10 Pack	1000991	FDA UDI	Class II	Active
t:slim X2 Insulin Pump with Control-IQ	1005012	FDA UDI	Class II	Active
t:slim Mobile Application, iOS	1014707	FDA UDI	Class II	Active
t:slim X2 Insulin Pump with Basal-IQ	1009639	FDA UDI	Class II	Active
Tandem Mobi Cartridge	1007737	FDA UDI	Class II	Active
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM	006194	FDA UDI	Class III	Active
t:slim X2 Insulin Pump with Control-IQ+ Technology	1014071	FDA UDI	Class II	Active
t:slim G4 Insulin Pump, Reconditioned	008542	FDA UDI	Class III	Active
Tandem t:slim Mobile Application, Android	1014706	FDA UDI	Class II	Active
t:flex Insulin Pump, Reconditioned	007666	FDA UDI	Class II	Active
t:slim G4 Cartridge 10 Pack	007526	FDA UDI	Class III	Active
t:slim Insulin Pump, Reconditioned Replacement	007262	FDA UDI	Class II	Active
Tandem Mobi Adhesive Sleeve	1010123	FDA UDI	Class I	Active
t:connect Mobile Application (Android)	1004127	FDA UDI	Class II	Active
t:slim Cartridge 2 Pack	006638	FDA UDI	Class II	Active
t:slim X2 Insulin Pump with Control-IQ Technology	1012868	FDA UDI	Class II	Active
Tandem Mobi Mobile Application	1015233	FDA UDI	Class II	Active
Tandem Mobi Autosoft XC Kit	1014119	FDA UDI	Class II	Active
t:slim X2 Insulin Pump with Basal-IQ	1000886	FDA UDI	Class III	Active
Tandem t:slim Autosoft 30 kit	1017076	FDA UDI	Class II	Active
t:connect Mobile Application, Mobile Bolus Enabled (Android)	1007112	FDA UDI	Class II	Active
t:flex Insulin Pump, Replacement	007516	FDA UDI	Class II	Active
t:connect Mobile Application (iOS)	1004128	FDA UDI	Class II	Active
t:flex Cartridge, t:lock, 10 Pack	1001390	FDA UDI	Class II	Active
t:slim X2 Insulin Pump with Basal-IQ	1000892	FDA UDI	Class III	Active
t:slim X2 Insulin Pump with Basal-IQ	1005698	FDA UDI	Class III	Active
Tandem Mobi Autosoft XC Kit	1013119	FDA UDI	Class II	Active
t:slim X2 Insulin Pump with Basal-IQ	1006379	FDA UDI	Class II	Active
t:slim X2 Insulin Pump with Control-IQ	1006404	FDA UDI	Class II	Active
t:slim X2 Insulin Pump	1000103	FDA UDI	Class II	Active
t:slim X2 Insulin Pump with Control-IQ	1009637	FDA UDI	Class II	Active
Tandem Mobi TruSteel Kit	1013122	FDA UDI	Class II	Active
Tandem t:slim Autosoft 30 kit	1017089	FDA UDI	Class II	Active
t:slim X2 Insulin Pump with Control-IQ Technology	1013198	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (13)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 30, 2026	Z-1636-2026	—	open, classified	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 to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event.
Oct 6, 2025	Z-0427-2026	—	open, classified	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 pump. Insulin delivery and any active CGM Sessions have been stopped", which could result in hyperglycemia.
Aug 5, 2025	Z-0232-2026	—	open, classified	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 could result in hypoglycemia.
Jul 21, 2025	Z-2343-2025	—	open, classified	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 hospitalization.
Jul 3, 2025	Z-2621-2025	—	open, classified	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.
Feb 27, 2025	Z-1519-2025	—	open, classified	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 a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.
Feb 27, 2025	Z-1520-2025	—	open, classified	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 a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.
Mar 5, 2024	Z-1609-2024	—	open, classified	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 sooner than typically expected. Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia.
May 24, 2022	Z-1812-2022	—	open, classified	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, hyperglycemia or diabetic ketoacidosis.
May 24, 2022	Z-1811-2022	—	open, classified	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, hyperglycemia or diabetic ketoacidosis.
Sep 10, 2020	Z-1258-2022	—	open, classified	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 insulin delivery will stop. If the battery reaches 1%, then insulin delivery will stop, which could lead to hyperglycemia.
Apr 23, 2018	Z-2471-2018	—	open, classified	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 pump shutting off, including Alert 2 (Battery Low), Alert 3 (Battery Very Low) and Alarm 12 (Battery Very Low). The alarms in both scenarios notify the user that the pump has stopped delivering insulin.
Jan 10, 2014	Z-0827-2014	—	terminated	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.