# FDA recall Z-1609-2024

> **Tandem Diabetes Care, Inc.** · Class I · device recall initiated 2024-03-05.

## Product

t:connect mobile app used in conjunction with  t:slim X2 insulin pump with Control-IQ technology

## Reason for recall

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.

## Distribution

US nationwide distribution including Puerto Rico.

## Key facts

- **Recall number:** Z-1609-2024
- **Recalling firm:** Tandem Diabetes Care, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-05
- **Report date:** 2024-05-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1609-2024

## Citation

> AI Analytics. FDA recall Z-1609-2024. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1609-2024. Source: US FDA. Licensed CC0.

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