t:slim X2 Insulin Pump
Published 6 June 2022
Product
t:slim X2 Insulin Pump The t:slim X2 Insulin Pump is intended for continuous insulin delivery and delivery of user activated insulin boluses, for the management of diabetes mellitus in persons requiring insulin. Product code: 1006419 Software version of 6.4.1 or prior ARTG 304681 (Australasian Medical & Scientific Ltd - Infusion pump, insulin, ambulatory)
Why it was recalled
The insulin pump may experience software issues which may disrupt insulin delivery.
Hazard
The issues may result in under delivery of insulin that may cause hyperglycemia, which can lead to serious health complications. In severe cases of hyperglycemia, the user may experience diabetic ketoacidosis and may require hospitalisation or intervention from a medical professional.
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.