t:slim X2 Insulin Pump with Control-IQ TechnologyRecalls & reported problems across all models
Tandem Diabetes Care, Inc. · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one t:slim X2 Insulin Pump with Control-IQ Technology model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 126,966
- Deaths reported
- 33
- Injuries reported
- 17,519
- Recalls
- 3
We found 11 models of t:slim X2 Insulin Pump with Control-IQ Technology by Tandem Diabetes Care, Inc. in the FDA's device registry (GUDID). Together they are named in 126,966 adverse event reports in the FDA's MAUDE database, received between Dec 28, 2023 and Sep 30, 2026 — classified as 33 deaths, 17,519 injuries, 109,414 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (45,666 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
t:slim X2 Insulin Pump with Control-IQ Technology recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 5, 2025Class IIOpen, Classified
A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may result in an unexpected automatic insulin correction bolus (autobolus ) which could result in hypoglycemia.
Z-0232-2026 · Root cause: Software change control · names 4 of these models · Recall details · FDA record ↗
- Jul 21, 2025Class IOpen, Classified
Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a hyperglycemic event, which may lead to injury and/or hospitalization.
Z-2343-2025 · Root cause: Nonconforming Material/Component · names 7 of these models · Recall details · FDA record ↗
- Feb 27, 2025Class IOpen, Classified
A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.
Z-1519-2025 · Root cause: Software Design Change · Recall details · FDA record ↗
Most reported t:slim X2 Insulin Pump with Control-IQ Technology problems
Device problems
- Pumping Stopped45,666
- Incorrect Measurement11,486
- Charging Problem9,927
- Adverse Event Without Identified Device or Use Problem8,256
- Obstruction of Flow7,552
- Failure to Charge7,371
- Communication or Transmission Problem4,918
- Battery Problem4,584
Patient problems
- No Clinical Signs, Symptoms or Conditions109,514
- Hyperglycemia12,681
- Hypoglycemia4,662
- Elevated Ketones/ Diabetic Ketoacidosis731
- Loss of consciousness304
- Insufficient Information227
- Fall102
- Vomiting62
t:slim X2 Insulin Pump with Control-IQ Technology models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- t:slim X2 Insulin Pump with Control-IQ Technology 1013198Alternate Controller Enabled Insulin Infusion Pump1 recall8 deaths47,637 reports
- t:slim X2 Insulin Pump with Control-IQ Technology 1013195Alternate Controller Enabled Insulin Infusion Pump1 recall7 deaths30,344 reports
- t:slim X2 Insulin Pump with Control-IQ+ Technology 1014073Alternate Controller Enabled Insulin Infusion Pump1 recall3 deaths14,875 reports
- t:slim X2 Insulin Pump with Control-IQ Technology 1013196Alternate Controller Enabled Insulin Infusion Pump1 recall8 deaths12,972 reports
- t:slim X2 Insulin Pump with Control-IQ+ Technology 1014070Alternate Controller Enabled Insulin Infusion Pump2 recalls3 deaths6,146 reports
- t:slim X2 Insulin Pump with Control-IQ Technology 1013197Alternate Controller Enabled Insulin Infusion Pump1 recall1 death4,448 reports
- t:slim X2 Insulin Pump with Control-IQ Technology 1012867Alternate Controller Enabled Insulin Infusion Pump1 recall4,145 reports
- t:slim X2 Insulin Pump with Control-IQ+ Technology 1014071Alternate Controller Enabled Insulin Infusion Pump1 recall2 deaths3,154 reports
- t:slim X2 Insulin Pump with Control-IQ Technology 1012868Alternate Controller Enabled Insulin Infusion Pump1 recall1,317 reports
- t:slim X2 Insulin Pump with Control-IQ+ Technology 1014072Alternate Controller Enabled Insulin Infusion Pump1 recall1 death1,036 reports
- t:slim X2 Insulin Pump with Control-IQ Technology 1012869Alternate Controller Enabled Insulin Infusion Pump1 recall892 reports
Recent t:slim X2 Insulin Pump with Control-IQ Technology adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955079 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955008 ↗MalfunctionSep 30, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955007 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955003 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954995 ↗MalfunctionSep 30, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954981 ↗MalfunctionSep 30, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954978 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954973 ↗MalfunctionSep 30, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954972 ↗InjurySep 30, 2026False Alarm
Patient problems: Hyperglycemia
MAUDE report 50954870 ↗MalfunctionSep 30, 2026Failure to Pump
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954869 ↗MalfunctionSep 30, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954864 ↗MalfunctionSep 30, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954753 ↗InjurySep 30, 2026False Alarm
Patient problems: Hyperglycemia
MAUDE report 50954747 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954610 ↗
Other Tandem Diabetes Care, Inc. products
- t:slim X2 Insulin Pump45 models · 897,233 reports · 4 recalls
- t:slim X2 Insulin Pump with Control-IQ11 models · 522,176 reports · 2 recalls
- t:slim X2 Insulin Pump with Basal-IQ14 models · 195,037 reports · 2 recalls
- Tandem Mobi7 models · 51,239 reports · 3 recalls
- t:slim X2 5.0 Insulin Pump5 models · 41,241 reports · 2 recalls
- t:slim X2 Insulin Pump2 models · 8,967 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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