The FDA announced on April 23, 2018, that Tandem Diabetes Care Inc. is recalling the t:slim G4 Insulin Pump with specific Dexcom G4 Platinum CGM software and firmware versions due to a faulty fuel gauge. The defect can cause inaccurate battery readings, triggering alarms that notify users the pump has stopped delivering insulin.
How to tell if you have it
- Brand: Tandem Diabetes Care
- 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.
- Serial Numbers: 483731, 483930, 483992, 484013, 492055, 492368, 501157, 501177, 501178, 501187, 501191, 501200, 501202, 501205, 501207, 501268, 501285, 501364, 501368, 501370, 501376, 501385, 501386, 501387, 501432, 501435, 501440, 501443, 501444, 501445, 501466, 501479, 501488, 501490, 501491, 501495, 501503, 501508, 501509, 501519, 501522, 501523, 501526, 501535, 501560, 504522, 504531, 504535, 504540, 504753, 504972, 504990, 505025, 90472671, 90488584
- Quantity: 55 units
The hazard
The fuel gauge component could provide inaccurate readings, presenting as either a Malfunction 4 Alarm or a succession of notifications including Alert 2 (Battery Low), Alert 3 (Battery Very Low) and Alarm 12 (Battery Very Low) before the pump shuts off. In both scenarios, these alarms notify the user that the pump has stopped delivering insulin.
Context
GovInfoNow's records show Tandem Diabetes Care, Inc. has had 10 other recalls on record since September 10, 2020. Other recent recalls of similar products include Medtronic MiniMed 780G Insulin Pump Recall (May 27, 2026), MiniMed Flex Insulin Pump Recall (August 20, 2026) and Medtronic MiniMed 630G Insulin Pump Recall (February 13, 2026).