Tandem Diabetes Care Inc: Medical Device Recall in 2018 - (Recall #: Z-2471-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: April 23, 2018

Date Posted: July 25, 2018

Recall Number: Z-2471-2018

Event ID: 79887

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.

Status: Ongoing

Product Quantity: 55

Code Information:

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

Distribution Pattern:

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,

Voluntary or Mandated:

Voluntary: Firm initiated