t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4 — Class II medical device recall Z-2471-2018
Ongoing recall by Tandem Diabetes Care Inc, reported 2018-07-25, distributed in AL, AZ, CA, CO, FL, ID, IL, IN…. The fuel gauge, the component that reads and reports the battery parameters to the pump, could provide inaccur
| Recall number | Z-2471-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tandem Diabetes Care Inc, San Diego, CA, United States |
| Recall initiated | 2018-04-23 |
| Classified | 2018-07-18 |
| Reported by FDA | 2018-07-25 |
| Distributed | AL, AZ, CA, CO, FL, ID, IL, IN, KY, MD, MN, MS, NJ, NM, NV, NY, OH, OR, PA, TX, UT, VA, WI |
| Quantity | 55 |
| Reason classes | device malfunction |
| 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 and 30 more |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2471-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.