PlainRecalls
FDA Devices Critical Class I Ongoing

t:slim X2 Insulin Pump with Interoperable Technology

Reported: April 23, 2025 Initiated: February 27, 2025 #Z-1519-2025

Product Description

t:slim X2 Insulin Pump with Interoperable Technology

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.

Details

Units Affected
63 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
Location
San Diego, CA

Frequently Asked Questions

What product was recalled? ▼
t:slim X2 Insulin Pump with Interoperable Technology. Recalled by Tandem Diabetes Care, Inc.. Units affected: 63 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 23, 2025. Severity: Critical. Recall number: Z-1519-2025.

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