The Recall Desk
HighFDA (Devices)·Z-2471-2018·Announced 2018-07-25

Tandem t:slim G4 Insulin Pump Recalled for Inaccurate Battery Readings

Tandem Diabetes Care is recalling 55 t:slim G4 Insulin Pumps because the fuel gauge may provide inaccurate battery readings, causing the pump to stop delivering insulin.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device that may stop delivering insulin, which is a risk-of-harm product. The source text does not report any specific injuries or illnesses, placing it in the 'High' category per the rubric.

Plain-English summary

Tandem Diabetes Care Inc is recalling 55 units of the t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM. The affected units are identified by specific serial numbers and are equipped with Software version 4.3.4.3 and Firmware version 004722.

The recall is due to a defect in the fuel gauge, the component that reads and reports battery parameters to the pump. This component may provide inaccurate readings, which can present to the user in two ways: by triggering a Malfunction 4 Alarm, or by triggering a succession of notifications (Alert 2, Alert 3, and Alarm 12) prior to the pump shutting off. In both scenarios, the alarms notify the user that the pump has stopped delivering insulin.

The affected products were distributed to consignees in the following U.S. states: IN, AZ, UT, TX, NY, NJ, MD, MN, IL, CO, AL, WI, CA, PA, OH, OR, MS, FL, NM, ID, NV, KY, and VA. Users of these specific serial numbers should contact Tandem Diabetes Care for instructions on how to proceed.

The recalled product

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.
Manufacturer
Tandem Diabetes Care Inc
Category
Medical Device — Insulin Pump
Hazard
Affected units
55

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Serial Numbers: 483731
  • 483930
  • 483992
  • 484013
  • 492055
  • 492368
  • 501157
  • 501177
  • 501178
  • 501187
  • 501191
  • 501200
  • 501202
  • 501205
  • 501207
  • 501268
  • 501285
  • 501364
  • 501368
  • 501370

Distribution

Distributed in 23 states:

Related recalls

Same manufacturer · Tandem Diabetes Care Inc

See all →