Use caution Medical device recall · FDA · Published September 10, 2020

Tandem Diabetes Care t:slim X2 Insulin Pump Battery Fluctuation Recall

Tandem Diabetes Care recalls t:slim X2 insulin pumps with Dexcom G5 or Basal-IQ tech due to potential battery fluctuations causing insulin delivery to stop, risking hyperglycemia.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1258-2022Medical device Tandem Diabetes Care ›

Use caution until it’s fixed

Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the battery life drops to less than 5%, insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop. If the battery reaches 1%, then insulin delivery will stop, which could lead to hyperglycemia.

Take action

Contact the company

Recalling firmTandem Diabetes Care Inc11075 Roselle St · San Diego, CA 92121-1204

✎ GovInfoNow plain-language explainer

Tandem Diabetes Care is recalling t:slim X2 insulin pumps with Dexcom G5 Mobile CGM or Basal-IQ Technology because battery fluctuations could stop insulin delivery, leading to hyperglycemia. This affects users who rely on these pumps for diabetes management. Read more at govinfonow.com/recall/64311-tandem-diabetes-care-t-slim-x2-insulin-pump-battery-fluctuation.

Source Summary by GovInfoNow · govinfonow.com/recall/64311-tandem-diabetes-care-t-slim-x2-insulin-pump-battery-fluctuation · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1258-2022

Cite this page

“Tandem Diabetes Care t:slim X2 Insulin Pump Battery Fluctuation Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64311-tandem-diabetes-care-t-slim-x2-insulin-pump-battery-fluctuation. Based on FDA recall #Z-1258-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1258-2022%22&limit=1).

The FDA announced on 2020-09-10 that Tandem Diabetes Care is recalling t:slim X2 Insulin Pumps with Dexcom G5 Mobile CGM and Basal-IQ Technology. The hazard involves unexpected battery fluctuations that can stop insulin delivery, potentially leading to hyperglycemia.

How to tell if you have it

Brand: Tandem Diabetes Care
Product: t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM; All Serial Numbers
Product: t:slim X2 Insulin Pump with Basal-IQ Technology; Software Versions 6.3.01 and Earlier
Quantity: 5,206 units
Distribution: International distribution in Australia

The hazard

According to the FDA, insulin pumps may display unexpected fluctuations of remaining battery life. If the battery drops below 5%, insulin delivery continues for 30 minutes before the pump powers off and stops delivering insulin. If the battery reaches 1%, insulin delivery stops immediately, which could lead to hyperglycemia.

Context

GovInfoNow's records show Tandem Diabetes Care has 10 other recalls on record since 2018-04-23. Other recent recalls of similar products include Tandem t:slim App Recall: Pairing Issue With Abbott Sensors (2026-07-16), Tand: Pumps with Czech guide errors may cause insulin delivery errors (2026-01-30), and Tandem Mobi Insulin Pump Recall: False Vibration Motor Failure Risk (2025-10-06). Other recent recalls of similar products include Medtronic Paradigm Insulin Pumps Recall: Risk of Severe Hypoglycemia or Hyperglycemia (2026-02-13), Medtronic MiniMed 620G Insulin Pump Recall: Risk of Severe Hypoglycemia or Hyperglycemia (2026-02-13), and Medtronic MiniMed 740G Insulin Pump Recall: Risk of Severe Hypoglycemia or Hyperglycemia (2026-02-13).

How to tell if you have this one

Check for Dexcom G5 Mobile CGM or Basal-IQ Technology on your pump. The affected pumps have specific serial numbers for Dexcom G5 and software versions 6.3.01 or earlier for Basal-IQ Technology.

Brand
Tandem Diabetes Care
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Battery Level
Monitor the pump's battery level to ensure it stays above 25% to prevent unexpected shutdowns.
Ensure Continuous Insulin Delivery
If battery drops below 5%, the pump will stop insulin delivery for 30 minutes; check with your healthcare provider for alternative management.

How this recall unfolded

Recall timeline

FDA published this recall 21 months after the firm started it.

Sep 10, 2020Firm started the recall
Jun 10, 2022FDA classified it Class II
Jun 22, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More Tandem Diabetes Care recalls

Link to this recall

<a href="https://govinfonow.com/recall/64311-tandem-diabetes-care-t-slim-x2-insulin-pump-battery-fluctuation">Tandem Diabetes Care t:slim X2 Insulin Pump Battery Fluctuation Recall (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1258-2022 (September 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1258-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.