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.
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.
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.
The insulin pump may show inaccurate battery level readings, causing it to stop delivering insulin when battery drops below 5%. This could lead to hyperglycemia (high blood sugar) if the pump stops unexpectedly without warning.
People with diabetes using t:slim X2 insulin pumps with Dexcom G5 Mobile CGM or Basal-IQ Technology software versions 6.3.01 and earlier are most at risk. These pumps may stop insulin delivery if battery levels drop below 5%.
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.
Monitor the pump's battery level to ensure it stays above 25% to prevent unexpected shutdowns.
If battery drops below 5%, the pump will stop insulin delivery for 30 minutes; check with your healthcare provider for alternative management.
The pump may stop insulin delivery if battery levels drop below 5% due to inaccurate battery readings. This could lead to hyperglycemia.
Check for Dexcom G5 Mobile CGM or Basal-IQ Technology software versions 6.3.01 and earlier. Affected pumps have specific serial numbers for Dexcom G5.
If the pump stops insulin delivery, contact your healthcare provider immediately for guidance on managing hyperglycemia.
We’ve drafted a message you can send Tandem Diabetes Care to request your refund or repair — edit it as you like.
Subject: Recall Z-1258-2022 — Tandem Diabetes Care Tandem Diabetes Care Hello, I own a Tandem Diabetes Care that is covered by recall Z-1258-2022 from Tandem Diabetes Care. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
