Tandem Diabetes Care, Inc. Recalls

Tandem Diabetes Care, Inc. recalls Tandem pumps are battery-operated infusion pumps capable of

The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event.

View recall details →

Tandem Diabetes Care, Inc. recalls Brand Name: Tandem t:slim mobile application Product Name: t

A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P) continuous glucose monitoring (CGM) sensors, resulting in the insulin pump being unable to establish a near-field communication (NFC) connection with the CGM and requiring FSL3P users to use their t:slim insulin pumps in manual mode. FSL3P users are unable to access their CGM's glucose values from within the t:slim app and cannot use their pumps in automated control (closed-loop) mode, which could lead to users experiencing hypoglycemia or hyperglycemia.

View recall details →