t:connect mobile app used in conjunction with t:slim X2 insulin pump… — Class I medical device recall Z-1609-2024
Ongoing recall by Tandem Diabetes Care, Inc., reported 2024-05-15, distributed nationwide. During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating s
| Recall number | Z-1609-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tandem Diabetes Care, Inc., San Diego, CA, United States |
| Recall initiated | 2024-03-05 |
| Classified | 2024-05-06 |
| Reported by FDA | 2024-05-15 |
| Distributed | Nationwide (US) |
| Quantity | 85,863 applications |
| UPC / GTIN / UDI-DI | 00850006613274 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1609-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.