Official recall record

t:slim X2 Insulin Pump with Interoperable Technology

US FDA — Medical Devices · 2025-02-27 · United StatesClass I

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2025-02-27
Country of alert: United States
Alert level: Class I
Alert type: recall
Barcode (EAN/GTIN): 00389152407012
Brand on record: Tandem Diabetes Care, Inc.

What the authority reported

A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or 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.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2025-08-05 · US FDA — Medical Devices
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, a

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,

All 6 official recall notices naming Tandem Diabetes Care, Inc. on this site →

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