FDA Medical Device Recalls (openFDA)
Tandem Diabetes Care, Inc.: Tandem Mobi Insulin Pump with Interoperable Technology
- Recall number
- Z-1520-2025
- Recalling firm
- Tandem Diabetes Care, Inc.
- Product
- Tandem Mobi Insulin Pump with Interoperable Technology
- Status
- Open, Classified
- Initiated
- 2025-02-27
- Posted
- 2025-04-11
- Terminated
- not on file
- Reason
- A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.
- Root cause
- Software Design Change
- Action
- On February 28, 2025 Tandem Diabetes Care contacted each affected customer by phone concerning a Urgent Medical Device Correction. On March 11, 2025, Tandem followed up with a "Urgent Medical Device" Recall notification via E-Mail to affected consignees. Tandem ask consignees to take the following action: 1. Turn off Control-IQ+ immediately. You may continue to use your pump without Control-IQ active. Your pump will deliver insulin based on your programmed active personal profile and will not automatically adjust insulin delivery. 2. Please refer to the user guide provided with your pump for more detailed instructions. 3. Continue using your Tandem pump as described in the User Guide. 4. Pay attention to all system alerts and alarms. 5. Always carry back-up supplies.
- Quantity
- 85 units
- Distribution
- US: AZ, CA, CO, CT, FL, HI, IA, ID, IL, IN, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, PA, TX, UT, VA, WA, WI OUS: N/A
- Lot, serial or model codes
- Software versions 7.9/UDI: 00389152480114
- 510(k) numbers
- ["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