Official recall record
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-03-05
- Country of alert
- United States
- Alert level
- Class I
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00850006613274
- Brand on record
- Tandem Diabetes Care, Inc.
What the authority reported
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 to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-07-16 · US FDA — Medical Devices
Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number - 2026-01-30 · US FDA — Medical Devices
Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pump - 2025-08-05 · US FDA — Medical Devices
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072,
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