Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3 Recalled by Tandem Diabetes Care Inc Due to The fuel gauge, the component that reads and...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Tandem Diabetes Care Inc directly.
Affected Products
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.
Quantity: 55
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 23 states: AL, AZ, CA, CO, FL, ID, IL, IN, KY, MD, MN, MS, NV, NJ, NM, NY, OH, OR, PA, TX, UT, VA, WI
About Tandem Diabetes Care Inc
Tandem Diabetes Care Inc has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report