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# Tandem Recalls t:slim Insulin Pumps
- URL: https://www.fdaweb.com/tandem-recalls-t-slim-insulin-pumps/
- Published: 2025-09-15T12:00:00.000Z
- Updated: 2026-09-14T15:21:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159865

Tandem Diabetes Care is recalling (Class 1 device correction) certain t:slim X2 insulin pumps after identifying a potential speaker-related issue that can trigger an error that will stop insulin delivery and render the pump no longer operational. The issue is called a “Malfunction 16” error and is caused by a wiring problem within the speaker, a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/insulin-pump-correction-tandem-diabetes-care-issues-correction-certain-tslim-x2-insulin-pumps-due?ref=fdaweb.com) says. 

Using affected products may result in insulin delivery stopping and missing monitoring of glucose values and trends, which could cause high blood sugar (hyperglycemia), the notice says. “In severe cases of hyperglycemia, serious adverse health consequences could occur, including the risk of intervention from a medical professional, hospitalization, or even death,” it says. To date, there have been 59 reported injuries.