Insulin pumps recalled over software defect causing unexpected correction bolus
Tandem Diabetes Care is recalling 122,958 t:slim X2 and Mobi insulin pumps because a software defect when paired with a Dexcom G7 sensor may trigger an unexpected automatic correction bolus.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: an unexpected insulin bolus can cause hypoglycemia, and no injuries are reported.
Plain-English summary
The t:slim X2 insulin pump with Control-IQ+ technology (REF 1014070, 1014071, 1014072 and 1014073) and the Tandem Mobi insulin pump with Control-IQ+ technology are being recalled, along with the user guide for use with the Dexcom G7 sensor.
A software defect in versions 7.9.0.1 and 7.10.1 of the t:slim X2 pump software, and version 7.9.0.1 of the Tandem Mobi pump software, when paired with a G7 sensor, may result in an unexpected automatic insulin correction bolus. The firm states this could result in hypoglycemia.
The recall covers 122,958 units, distributed nationwide in the United States including Puerto Rico. The FDA has classified the action as Class II.
The enforcement record describes the defect and reports no injuries. Users should follow Tandem's instructions regarding the affected software versions.
The recalled product
- Product
- 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
- Manufacturer
- Tandem Diabetes Care, Inc.
- Category
- Medical Device — Insulin pump
- Affected units
- 122,958
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 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
Distribution
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