# FDA recall Z-1519-2025

> **Tandem Diabetes Care, Inc.** · Class I · device recall initiated 2025-02-27.

## Product

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.

## 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

## Key facts

- **Recall number:** Z-1519-2025
- **Recalling firm:** Tandem Diabetes Care, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-27
- **Report date:** 2025-04-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1519-2025

## Citation

> AI Analytics. FDA recall Z-1519-2025. Retrieved 2026-08-02 from https://api.ai-analytics.org/recall/Z-1519-2025. Source: US FDA. Licensed CC0.

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