Tandem Diabetes Care, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1609-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: March 5, 2024

Date Posted: May 15, 2024

Recall Number: Z-1609-2024

Event ID: 94312

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.

Status: Ongoing

Product Quantity: 85,863 applications

Code Information:

version 2.7 or later /UDI: 00850006613274

Distribution Pattern:

US nationwide distribution including Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated