t:connect mobile app used in conjunction with t:slim X2 recall
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Why was t:connect mobile app used in conjunction with t:slim X2 recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
version 2.7 or later /UDI: 00850006613274
- Product
- t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
- Recalling firm
- Tandem Diabetes Care, Inc.
- Quantity
- 85,863 applications
- Distribution
- US nationwide distribution including Puerto Rico.
- Recall date
- May 15, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)