FDA Device recall Z-1609-2024
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
- FDA Device
- Class I
- ongoing
- Published 2024-05-15
On 2024-05-15 the FDA classified a Class I recall of t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology by Tandem Diabetes Care, citing 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 Bl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1609-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-03-05 |
| Published | 2024-05-15 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Tandem Diabetes Care |
| Distribution | US |
Product
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Reason
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.
Identifiers
| code_info | version 2.7 or later /UDI: 00850006613274 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1609-2024%22
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