Tandem Mobi recallZ-1520-2025 · Tandem Diabetes Care, Inc. · initiated Feb 27, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Tandem Diabetes Care, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software Design Change
What the company is doing
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.
Recall details
- Recall number
- Z-1520-2025
- Status
- Open, Classified
- Initiated by the company
- Feb 27, 2025
- Posted by the FDA
- Apr 11, 2025
- Recalling firm
- Tandem Diabetes Care, Inc.
- Quantity
- 85 units
- Product code
- QFG
- FDA submissions
- K241078
- 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
Product description
Tandem Mobi Insulin Pump with Interoperable Technology
Code information (models, lots, serial numbers)
Software versions 7.9/UDI: 00389152480114
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Tandem Mobi, pump, Control-IQ 7.9 1014801Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump2 recalls1 death7,327 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K241078 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Pharmacy Kit, Starter Pack, Tandem Mobi, Control-IQ+ 1014936Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump47 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 96417).
- Z-1519-2025 · Open, Classifiedt:slim X2 Insulin Pump with Interoperable Technology
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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