> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Tandem Recalls Insulin Pumps Due to Alarm Error
- URL: https://www.fdaweb.com/tandem-recalls-insulin-pumps-due-to-alarm-error/
- Published: 2025-08-18T12:00:00.000Z
- Updated: 2026-09-14T15:19:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159703

Tandem Diabetes Care has recalled (Class 1 device correction) for certain t:slim X2 insulin pumps to address a potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery. “The error, which appears as a Malfunction 16 alarm to the user, will stop insulin delivery and terminate communication between the insulin pump and the continuous glucose monitoring (CGM) device,” a [recall notice](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tandem-diabetes-care-issues-voluntary-medical-device-correction-select-tslim-x2-insulin-pumps?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. If not addressed, this could result in hyperglycemia due to discontinuation of insulin delivery, it says.

Notices were sent directly to impacted customers last month. Tandem notes it will be releasing a software update designed to help with early detection of the speaker failure.