Tandem recalls t:slim X2 insulin pumps with software version 7.9 that may incorrectly interpret glucose trends, risking unsafe insulin delivery. Affected units sold with UDI 00389152407012.
A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.
Tandem is recalling t:slim X2 insulin pumps with software version 7.9 that may cause incorrect glucose readings when used with certain diabetes monitors. This could lead to dangerous insulin levels if the pump misinterprets high glucose values.
The software defect causes the pump to misread glucose trends when the estimated glucose value exceeds 255 mg/dL at the start or end of data gaps. This can result in the pump delivering too much or too little insulin, potentially causing severe hypoglycemia or hyperglycemia.
People with diabetes using Tandem t:slim X2 pumps with software version 7.9 and Control IQ+ technology are most at risk. Those who use continuous glucose monitors with these pumps may experience inaccurate readings.
Check for software version 7.9 on your t:slim X2 pump. Affected units have a unique device identifier (UDI) of 00389152407012.
Verify your pump's software version; if it's 7.9, it's affected.
Contact Tandem to update to a newer software version that fixes this issue.
The software defect in version 7.9 causes the pump to incorrectly interpret glucose trends when the estimated glucose value exceeds 255 mg/dL at the start or end of data gaps, potentially leading to unsafe insulin delivery.
Check for software version 7.9 on your t:slim X2 pump. Affected units have a unique device identifier (UDI) of 00389152407012.
Contact Tandem to update to a newer software version that fixes this issue. Do not use the pump until updated.
We’ve drafted a message you can send Tandem to request your refund or repair — edit it as you like.
Subject: Recall Z-1519-2025 — Tandem Tandem Hello, I own a Tandem that is covered by recall Z-1519-2025 from Tandem. 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.
