Insulin Pump Correction: Tandem Diabetes Care Issues Correction for Certain t:slim X2 Insulin Pumps Due to Risk for Faulty Speaker Wiring That May Cause Malfunction and Stop Insulin Delivery
This recall involves correcting certain devices through a software update, and does not involve removing them from where they are used unless or until a malfunction occurs. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
- Product Name: t:slim X2
- Model/UDI: See full list of affected devices.
What to Do
- Review the searchable list of serial numbers to determine if your pump is impacted at tandemdiabetes.com/mal16-2025.
- Continue using Tandem pumps as long as they have not experienced a Malfunction 16 error, but with added precautions (see below) because the Malfunction 16 can occur at any time.
- Switch to another method of insulin delivery if a Malfunction 16 occurs and contact Tandem at 1-877-801-6901 or Techsupport@tandemdiabetes.com to arrange for a replacement pump.
On July 22, 2025, Tandem sent all affected customers an Urgent Medical Device Correction letter recommending the following actions.
All users with affected pumps:
- Complete the online form acknowledging receipt of the notice: campaign.tandemdiabetes.com/FCA-Malfunction-16
- Look up the pump serial number to confirm if the pump is affected.
- Be prepared with a backup method of insulin delivery as directed by a physician and as set forth in the pump training and laid out in the pump user guide.
If a Malfunction 16 hasn’t occurred:
- Continue using the pump as described in the User Guide, but with added precautions because the Malfunction 16 can happen at any time.
- Use the Tandem t:slim mobile app with push notifications turned “ON” so if the malfunction does occur, the user receives app notification.
- See the article on Tandem’s support page for more information about setting up alerts from the mobile app.
- Dexcom sensor users should use the Dexcom mobile app as a secondary means of continuous glucose monitor alerts and alarms.
- Contact Tandem at 1-877-801-6901 or Techsupport@tandemdiabetes.com if unable to download and use the Tandem t:slim mobile app and/or the Dexcom mobile app.
If a Malfunction 16 alert is received:
- Promptly acknowledge it by pressing “Silence Alarm.”
- Contact Tandem at 1-877-801-6901 or Techsupport@tandemdiabetes.com to arrange for a replacement pump.
- Switch to a backup method of insulin delivery as directed by a physician.
- Regularly check blood sugar to make sure there are no unexpectedly high or low readings.
Tandem Diabetes Care will release a software update to enhance early detection of speaker failure and introduce persistent vibration alerts to help reduce potential safety risk. Affected pump users will be notified by Tandem when the software update becomes available so pump users may complete the software update.
Reason for Correction
Tandem Diabetes Care is correcting certain t:slim X2 insulin pumps after identifying a potential speaker-related issue that can trigger an error (Malfunction 16), which 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.
The use of the affected product may result in insulin delivery stopping and missing real-time reporting of continuous glucose monitoring (CGM) estimated glucose values and glucose trends, which could cause high blood sugar (hyperglycemia). In severe cases of hyperglycemia, serious adverse health consequences could occur, including the risk of intervention from a medical professional, hospitalization, or even death.
There have been 59 reported injuries and no reports of death.
Device Use
The t:slim X2 insulin pump is used by people age 2 or older to manage diabetes, a health condition where blood glucose levels are too high (also called diabetes mellitus). The pumps provide doses of the hormone insulin under the skin (subcutaneously). Insulin helps move glucose from the blood into the body’s cells, where it can be used for energy.
Contact Information
Customers in the U.S. with questions about this recall should contact Tandem Diabetes Care Customer Technical Support at 1-877-801-6901 or Techsupport@tandemdiabetes.com.
Full List of Affected Devices
Catalog | Catalog# Description | UDI-DI |
| 1000911 | t:slim X2 GS, Replacement, Refurbished | 00853052007318 |
| 1003808 | t:slim X2 GS Classic, Replacement, Refurbished | 00853052007981 |
| 1004219 | t:slim X2, Basal-IQ, mg/dl | 00853052007998 |
| 1004484 | Pump, t:slim X2, Clinical Use Only | N/A |
| 1005611 | Pump, t:slim X2, Control-IQ, mmol/L | 00850006613304 |
| 1005613 | Pump, t:slim X2, Control-IQ, mmol/L, Refurbished Replacement | 00850006613311 |
| 1005615 | Pump, t:slim X2, Control-IQ, mg/dl | 00850006613328 |
| 1005617 | Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement | 00850006613335 |
| 1006379 | Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement | 00850006613731 |
| 1006402 | Pump, t:slim X2, Control-IQ 7.4 | 00850006613762 |
| 1006406 | Pump, t:slim X2, Control-IQ 7.4, Replacement | 00850006613786 |
| 1006408 | Pump, t:slim X2, Control-IQ 7.4, Refurbished Replacement | 00850006613793 |
| 1006419 | Pump, t:slim X2, Basal-IQ, mmol/L | 00850006613809 |
| 1006420 | Pump, t:slim X2, Basal-IQ, mg/dl | 00850006613816 |
| 1006535 | Pump, t:slim X2, Basal-IQ, mmol/L, Refurbished Replacement | 00850006613823 |
| 1006537 | Pump, t:slim X2, Basal-IQ, mg/dl, Refurbished Replacement | 00850006613830 |
| 1008255 | Pump, t:slim X2, Control-IQ, mg/dl, Replacement | 00850018992671 |
| 1008256 | Pump, t:slim X2, Control-IQ, mmol/L, Replacement | 00850018992664 |
| 1008257 | Pump, t:slim X2, Basal-IQ, mmol/L, Replacement | 00850018992657 |
| 1008258 | Pump, t:slim X2, Basal-IQ, mg/dl,Replacement | 00850018992640 |
| 1010004 | Pump, t:slim X2, Basal-IQ | 00389152000015 |
| 1010005 | Pump, t:slim X2, Basal-IQ, Replacement | 00389152000022 |
| 1010006 | Pump, t:slim X2, Basal-IQ, Medicare | 00389152000039 |
| 1010007 | Pump, t:slim X2, Basal-IQ, Refurbished Replacement | 00389152000046 |
| 1010009 | Pump, t:slim X2, Control-IQ | 00389152000077 |
| 1010010 | Pump, t:slim X2, Control-IQ, Replacement | 00389152000084 |
| 1010011 | Pump, t:slim X2, Control-IQ, Medicare | 00389152000091 |
| 1010012 | Pump, t:slim X2, Control-IQ, Refurbished Replacement | 00389152000107 |
| 1012867 | Pump, t:slim X2, Control-IQ | 00389152286716 |
| 1012868 | Pump, t:slim X2, Control-IQ, Medicare | 00389152286815 |
| 1012869 | Pump, t:slim X2, Control-IQ, Replacement | 00389152286914 |
| 1013195 | Pump, t:slim X2, Control-IQ 7.8 | 00389152319513 |
| 1013196 | Pump, t:slim X2, Control-IQ 7.8, Medicare | 00389152319612 |
| 1013197 | Pump, t:slim X2, Control-IQ 7.8, Replacement | 00389152319711 |
| 1013198 | Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement | 00389152319810 |
Additional FDA Resources:
Additional Company Resources (listed in order of most to least recent):
Company provided information on a recall is posted here by the FDA as a public service.
Firm Press Release [08/07/2025]
Firm Recall/Correction Letter [07/25/2025]
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.