# FDA recall Z-2471-2018

> **Tandem Diabetes Care Inc** · Class II · device recall initiated 2018-04-23.

## Product

t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM    Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B.

## Reason for recall

The fuel gauge, the component that reads and reports the battery parameters to the pump, could provide inaccurate readings, which present to the user in one of two ways:   A) by triggering a Malfunction 4 Alarm, or   B) by triggering a succession of notifications prior to the pump shutting off, including Alert 2 (Battery Low), Alert 3 (Battery Very Low) and Alarm 12 (Battery Very Low). The alarms in both scenarios notify the user that the pump has stopped delivering insulin.

## Distribution

U.S. Consignees: IN, AZ, UT, TX, NY, NJ, MD, MN, IL, CO, AL, WI,   CA, PA, OH, OR, MS, FL, NM, ID, NV, KY, VA,

## Key facts

- **Recall number:** Z-2471-2018
- **Recalling firm:** Tandem Diabetes Care Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-04-23
- **Report date:** 2018-07-25

- **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-2471-2018

## Citation

> AI Analytics. FDA recall Z-2471-2018. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/Z-2471-2018. Source: US FDA. Licensed CC0.

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