United StatesThe t:slim X2 insulin pump with Interoperable Technology (REF 1014070, 1014071, 1014072, 1014073; UDI-DI 00389152407012, 00389152407111, 00389152407210, 00389152407319) with software versions 7.9.0.1 or 7.10.1, and the Tandem Mobi insulin pump with Interoperable Technology (REF 1014801, 1014811, 1014813; UDI-DI 00389152480114, 00389152481111, 00389152481319) with software version 7.9.0.1 are affected when paired with a Dexcom G7 sensor; affected User Guide versions are those not including and prior to AW-1014562 Revision D (t:slim X2) and AW-1014938 Revision C (Mobi). They were recalled because a software defect may cause an unexpected automatic insulin correction bolus (autobolus), which could result in hypoglycemia.
What's being recalled
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
Recalling firm: Tandem Diabetes Care, Inc., San Diego, CA, United States.
How to identify it
t:slim X2, UDI-DI: 00389152407012, 00389152407111, 00389152407210, 00389152407319 with software versions 7.9.0.1 and 7.10.1, User Guide versions not including and prior to: AW-1014562 Revision D; Tandem Mobi, UDI-DI: 00389152480114, 00389152481111, 00389152481319 with software version 7.9.0.1, User Guide versions not including and prior to: AW-1014938 Revision C
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US nationwide distribution including Puerto Rico.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)