Z-2471-2018Class II

t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722...

Name: Z-2471-2018 t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722...
Creator: Tandem Diabetes Care Inc
Published: 2018-04-23
License: https://open.fda.gov/license/

Tandem Diabetes Care, Inc. / initiated 2018-04-23 / Open, Classified / root cause: design

FDA source

Tandem Diabetes Care Inc began a 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 on 2018-04-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2471-2018
Classification: Class II
Status: Open, Classified
Initiated: 2018-04-23
Posted: 2018-07-18
Recalling firm: Tandem Diabetes Care, Inc.
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.
Product code: OYC Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
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.
Root cause tag: design
FDA root cause: Device Design
Action: On 04/23/2018, customers were sent Urgent Medical Device Voluntary Recall letters via overnight mail delivery and email. The letter instructed customers to call Customer Support at 1-877-801-6901 to arrange for replacement pumps. Customers were advised to continue using effected devices provided they kept Emergency Kits with backup insulin supplies with them. If customers noted unexpected battery behavior, malfunction 4 alarm, or the following alerts: Alert 2 (Battery Low), Alert 3 (Battery Very Low) and Alarm 12 (Battery Very Low), then customers were advised to discontinue use and use backup insulin supplies, while they waited for replacement pumps. The firm advised customers to fill out and return via fax, email, or mail Medical Device Recall Return Response forms.
Quantity in commerce: 55
Distribution: 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,
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2471-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2471-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-07-25	2018-07-18

Product code OYC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)