Tandem Diabetes Care, Inc.: Device Recall

Recall Details

Recall Number

Z-2621-2025

Classification

Class II

Product Type

Device

Recalling Firm

Tandem Diabetes Care, Inc.

Status

Ongoing

Date Initiated

07/03/2025

Location

San Diego, CA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

19

Reason for Recall

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.

Product Description

t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)

Distribution Pattern

International distribution to the country of Israel.

Other Recalls by Tandem Diabetes Care, Inc.

• Class I: Dangerous 10/06/2025
  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.
• Class II: Risk 08/05/2025
  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.
• Class I: Dangerous 07/21/2025
  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.
• Class I: Dangerous 02/27/2025
  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.
• Class I: Dangerous 02/27/2025
  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.

View all recalls by Tandem Diabetes Care, Inc. →