FDA Device recall Z-2471-2018
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
- FDA Device
- Class II
- ongoing
- Published 2018-07-25
On 2018-07-25 the FDA classified a Class II recall of 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 by Tandem Diabetes Care, citing 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 tri….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2471-2018 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-04-23 |
| Published | 2018-07-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Tandem Diabetes Care |
| Distribution | AL, AZ, CA, CO, FL, ID, IL, IN, KY, MD, MN, MS, NJ, NM, NV, NY, OH, OR, PA, TX, UT, VA, WI |
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
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.
Identifiers
| code_info | Serial Numbers: 483731, 483930, 483992, 484013, 492055, 492368, 501157, 501177, 501178, 501187, 501191, 5012…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2471-2018%22
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