Reported Apr 23, 2025 · Ongoing
t:slim X2 Insulin Pump with Interoperable Technology
Tandem Diabetes Care, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tandem Diabetes Care, Inc. · 12400 High Bluff Dr · San Diego, CA · 92130-3077
Is this the product you have?
- t:slim X2 Insulin Pump with Interoperable Technology
- Lot codes and dates
- Software versions 7.9/UDI: 00389152407012
- Amount recalled
- 63 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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