Z-1520-2025Class I

Tandem Mobi Insulin Pump with Interoperable Technology

Name: Z-1520-2025 Tandem Mobi Insulin Pump with Interoperable Technology
Creator: Tandem Diabetes Care, Inc.
Published: 2025-02-27
License: https://open.fda.gov/license/

Tandem Diabetes Care, Inc. / initiated 2025-02-27 / Open, Classified / root cause: software

FDA source

Tandem Diabetes Care, Inc. began a recall of Tandem Mobi Insulin Pump with Interoperable Technology on 2025-02-27. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1520-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-02-27
Posted: 2025-04-11
Recalling firm: Tandem Diabetes Care, Inc.
Product: Tandem Mobi Insulin Pump with Interoperable Technology
Product code: QFG Alternate Controller Enabled Insulin Infusion Pump
Reason for recall: 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 tag: software
FDA 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 in commerce: 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
Product codes and lots: Software versions 7.9/UDI: 00389152480114

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1520-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1519-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-11
Z-1520-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-11

Product code QFG

K241078Class IITandem Mobi Insulin Pump with interoperable technologyTandem Diabetes Care, Inc. / cleared 2024-07-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)