The Recall Desk
HighFDA (Devices)·Z-1258-2022·Announced 2022-06-22

Tandem t:slim X2 Insulin Pump Battery Display May Cause Insulin Delivery Failure

Tandem t:slim X2 insulin pumps may display inaccurate battery levels, risking insulin delivery failure if the battery depletes unexpectedly. Users should maintain battery above 25% to prevent unintended insulin cessation.

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: FDA Class II recall with no reported injuries or deaths. The recall addresses risk-of-harm from unintended insulin delivery stoppage if battery fully depletes, which could lead to hyperglycemia. This risk is mitigable through patient battery monitoring.

Plain-English summary

Tandem Diabetes Care is recalling the t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM and t:slim X2 with Basal-IQ Technology due to a battery display issue that may cause unexpected insulin delivery stoppage.

The pumps may show inaccurate remaining battery life. Users must keep the battery above 25% to avoid insulin delivery failure. When battery drops below 5%, insulin delivery will continue for 30 minutes and then stop. If the battery reaches 1%, insulin delivery will stop immediately, which could lead to hyperglycemia (high blood sugar).

This recall affects approximately 5,206 units distributed internationally in Australia. The affected products include Dexcom G5 sensors with all serial numbers and t:slim X2 pumps with Basal-IQ software versions 6.3.01 and earlier.

Users should monitor their pump battery level closely and ensure it does not fall below 25%. If the battery depletes despite monitoring, insulin delivery may stop unexpectedly. Patients should contact Tandem Diabetes Care or their healthcare provider if they have questions about their device.

The recalled product

Product
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Manufacturer
Tandem Diabetes Care Inc
Category
Medical Device — Insulin pump / Continuous glucose monitoring
Hazard
  • insulin-delivery-failure
  • battery-indicator-inaccuracy
  • hyperglycemia-risk

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 (2)

  • Dexcom G5 - All Serial Numbers
  • Basal-IQ Technology - Software Versions 6.3.01 and Earlier

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category