t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Published May 15, 2024 · Recall initiated: March 5, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Tandem Diabetes Care, Inc.
- Distributor
- US nationwide distribution including Puerto Rico.
- Lot
- version 2.7 or later /UDI: 00850006613274
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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