FDA Medical Device Recalls (openFDA)
Tandem Diabetes Care, Inc.: 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
- Recall number
- Z-0232-2026
- Recalling firm
- Tandem Diabetes Care, Inc.
- 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 User Guide when using Dexcom G7 sensor
- Status
- Open, Classified
- Initiated
- 2025-08-05
- Posted
- 2025-10-23
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Software change control
- Action
- On 8/5/2025, Field Safety Notices were sent to customers informing them of the following: Actions to avoid the issue: - Wait until your G7 sensor session ends before inserting a new G7 sensor. - However, if you do insert a new G7 sensor before your last sensor session ends, wait to pair until at least 20 minutes after the last session ends. Firm is working on a software update to resolve this issue. If you have questions or need help, please call firm's Customer Support 1-877-801-6901 or email Techsupport@tandemdiabetes.com. Our team is available 24/7/365. On 9/16/2025, correction notices were emailed to customers who were informed the firm updated user guides to align with instructions in the correction notice. Also, the firm will notify impacted users via an updated Field Correction Notice when the software update is available. The notice will provide instructions on how to remotely update their software.
- Quantity
- 122,958
- Distribution
- US nationwide distribution including Puerto Rico.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K201214","K203234","K240309","K241078"]
- PMA numbers
- not on file
- Product code
- QFG
- Firm FEI
- 3007981285
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28