FDA-Device2025-10-29Class IIPROCESSING DEFECT

Tandem t:slim X2 and Mobi insulin pumps recalled for unexpected insulin bolus with Dexcom G7

OTHERNationwide distribution

Tandem insulin pumps recalled for unexpected insulin dose risk

Tandem Diabetes Care insulin pumps (t:slim X2 and Mobi models) with certain software versions may deliver an unexpected automatic insulin correction dose when paired with a Dexcom G7 sensor. This could cause low blood sugar (hypoglycemia). The issue affects specific software versions: t:slim X2 versions 7.9.0.1 and 7.10.1, and Mobi version 7.9.0.1.

  • If you use a t:slim X2 or Mobi pump with Control-IQ+ and a Dexcom G7 sensor, check your pump's software version in the settings menu.
  • Update your pump software to the latest version available through the Tandem t:connect app or contact Tandem support.
  • Review the updated User Guide that came with your update (revision D for t:slim X2, revision C for Mobi).
  • Monitor your blood sugar closely and watch for signs of low blood sugar until your pump is updated.
Hazard

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.

Sold states
US nationwide distribution including Puerto Rico.
Affected count
122,958
Manufactured in
12400 High Bluff Dr, San Diego, CA, United States
Products
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor; Tandem Mobi insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014801, 1014811, 1014813, and User Guide when using Dexcom G7 sensor

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0232-2026

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