[pending] t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071,
Pending LLM rewrite. Source: FDA_DEVICE Z-0232-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
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.
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 — Devices
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
Distributed nationwide across the United States.
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