Class I — Tandem Diabetes Care, Inc.
| Recalling firm | Tandem Diabetes Care, Inc. |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| 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. |
| Product | t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology |
| Quantity | 85,863 applications |
| Distribution | US nationwide distribution including Puerto Rico. |
| Initiated | 2024-03-05 |
| Classified | 2024-05-06 |
| Recall number | Z-1609-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Tandem Diabetes Care, Inc. (Z-1609-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94312/
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