FDA Device Recall Z-1609-2024

Tandem Diabetes Care, Inc. · San Diego, CA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

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

Lot / serial / GTIN: version 2.7 or later /UDI: 00850006613274

Quantity: 85,863 applications

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.

Recall record

Recall number: Z-1609-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US nationwide distribution including Puerto Rico.
Recall initiated: 2024-03-05
Classified by FDA Center: 2024-05-06
FDA published: 2024-05-15
Recalling firm: Tandem Diabetes Care, Inc.
Firm location: San Diego, CA

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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