CLASS II ONGOING Device recall · Reported 25 Jul 2018 · FDA Enforcement Report
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM recalled
Tandem Diabetes Care is recalling t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM, distributed in 23 states. The recall was initiated on 23 Apr 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2471-2018
- FDA event ID
- 79887
- Recalling firm
- Tandem Diabetes Care, San Diego, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Apr 2018
- FDA classified
- 18 Jul 2018
- Reported
- 25 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 23 Apr 2018 | Recall initiated by company | |
| 18 Jul 2018 | Classified by FDA | +86 days |
| 25 Jul 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
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,
AlabamaArizonaCaliforniaColoradoFloridaIdahoIllinoisIndianaKentuckyMarylandMinnesotaMississippiNew JerseyNew MexicoNevadaNew YorkOhioOregonPennsylvaniaTexas
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
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,
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Tandem Diabetes Care
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Tandem pumps are battery-operated infusion pumps capable recalled | Tandem Diabetes Care | Device Malfunction | CA |
| Device | CLASS I | Tandem Mobi Insulin Pump: Description recalled by Tandem Diabetes Care | Tandem Diabetes Care | Device Malfunction | 52 states |
| Device | CLASS II | t:slim X2 insulin pump with Interoperable Technology recalled | Tandem Diabetes Care | Device Malfunction | Nationwide |
| Device | CLASS II | t:slim X2 Insulin Pump with Interoperable Technology recalled | Tandem Diabetes Care | Device Malfunction | CA |
| Device | CLASS I | Tandem Mobi Insulin Pump with Interoperable Technology recalled | Tandem Diabetes Care | Labeling Errors | 29 states |
Other Insulin Pumps & Glucose Monitors recalls
All 465| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | ANNOUNCED | StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip | Nova Biomedical | Device Malfunction | |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |