Summary
The FDA issued a Class I for Tandem Mobi Insulin Pump with Interoperable Technology by Tandem Diabetes Care, Inc.. 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 th.
Details
Source
Device Recall
External ID
Z-1520-2025
Action Date
2025-04-23
Status
Ongoing
Category
device
Product Description
Tandem Mobi Insulin Pump with Interoperable Technology
Lot/Code Info: Software versions 7.9/UDI: 00389152480114
Quantity Affected: 85 units
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-27
Company
San Diego, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 165 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Tandem Diabetes Care, Inc. has 22 FDA actions in our database, including 11 recalls and 11 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Tandem Diabetes Care, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tandem Diabetes Care, Inc. have FDA actions?
Tandem Diabetes Care, Inc. has 22 FDA actions in our database, including 11 recalls and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1520-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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