Reported May 15, 2024 · Ongoing
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ 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. · 11075 Roselle St · San Diego, CA · 92121-1204
Is this the product you have?
- t:connect
- mobile app used in conjunction with tslim X2 insulin pump with Control-IQ technology
- Lot codes and dates
- version 2.7
- or later /UDI00850006613274
- Amount recalled
- 85,863 applications
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected. Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia.
Using this product could cause serious injury, illness or death — stop using it now.
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