t:slim X2 Insulin Pump with Control-IQRecalls & 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
2 open recalls name at least one t:slim X2 Insulin Pump with Control-IQ model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 522,176
- Deaths reported
- 72
- Injuries reported
- 55,247
- Recalls
- 2
We found 11 models of t:slim X2 Insulin Pump with Control-IQ by Tandem Diabetes Care, Inc. in the FDA's device registry (GUDID). Together they are named in 522,176 adverse event reports in the FDA's MAUDE database, received between Jan 23, 2020 and Sep 30, 2026 — classified as 72 deaths, 55,247 injuries, 466,857 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (162,145 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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 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.
- 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 ↗
- May 24, 2022Class IIOpen, Classified
Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, 4) Unexpected Open Loop, that can be mitigated with a software update. Issues could result in hypoglycemia, hyperglycemia or diabetic ketoacidosis.
Z-1811-2022 · Root cause: Device Design · names 7 of these models · Recall details · FDA record ↗
Most reported t:slim X2 Insulin Pump with Control-IQ problems
Device problems
- Pumping Stopped162,145
- Incorrect Measurement52,380
- Charging Problem51,721
- Battery Problem43,376
- Obstruction of Flow31,947
- Adverse Event Without Identified Device or Use Problem31,374
- Communication or Transmission Problem30,574
- Failure to Sense23,621
Patient problems
- No Clinical Signs, Symptoms or Conditions446,931
- Hyperglycemia36,108
- Hypoglycemia17,842
- No Consequences Or Impact To Patient17,188
- Elevated Ketones/ Diabetic Ketoacidosis3,355
- No Known Impact Or Consequence To Patient3,096
- Insufficient Information1,260
- Loss of consciousness776
t:slim X2 Insulin Pump with Control-IQ 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 1006402Alternate Controller Enabled Insulin Infusion Pump2 recalls18 deaths159,247 reports
- t:slim X2 Insulin Pump with Control-IQ 1006408Alternate Controller Enabled Insulin Infusion Pump2 recalls12 deaths92,526 reports
- t:slim X2 Insulin Pump with Control-IQ 1009637Alternate Controller Enabled Insulin Infusion Pump1 recall4 deaths83,884 reports
- t:slim X2 Insulin Pump with Control-IQ 1009643Alternate Controller Enabled Insulin Infusion Pump1 recall7 deaths51,110 reports
- t:slim X2 Insulin Pump with Control-IQ 1006404Alternate Controller Enabled Insulin Infusion Pump1 recall18 deaths43,718 reports
- t:slim X2 Insulin Pump with Control-IQ 1005011Alternate Controller Enabled Insulin Infusion Pump1 recall3 deaths35,600 reports
- t:slim X2 Insulin Pump with Control-IQ 1009641Alternate Controller Enabled Insulin Infusion Pump1 recall8 deaths25,864 reports
- t:slim X2 Insulin Pump with Control-IQ 1006406Alternate Controller Enabled Insulin Infusion Pump2 recalls1 death10,997 reports
- t:slim X2 Insulin Pump with Control-IQ 1009642Alternate Controller Enabled Insulin Infusion Pump1 recall1 death10,004 reports
- t:slim X2 Insulin Pump with Control-IQ 1005013Alternate Controller Enabled Insulin Infusion Pump1 recall5,097 reports
- t:slim X2 Insulin Pump with Control-IQ 1005012Interoperable Automated Glycemic Controller1 recall4,129 reports
Recent t:slim X2 Insulin Pump with Control-IQ adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50955106 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955096 ↗MalfunctionSep 30, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954999 ↗InjurySep 30, 2026False Alarm
Patient problems: Hyperglycemia
MAUDE report 50954985 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954983 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954974 ↗MalfunctionSep 30, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954967 ↗MalfunctionSep 30, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954868 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954857 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954855 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954850 ↗MalfunctionSep 30, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954748 ↗MalfunctionSep 30, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954739 ↗MalfunctionSep 30, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954738 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954256 ↗
Other Tandem Diabetes Care, Inc. products
- t:slim X2 Insulin Pump45 models · 897,233 reports · 4 recalls
- t:slim X2 Insulin Pump with Basal-IQ14 models · 195,037 reports · 2 recalls
- t:slim X2 Insulin Pump with Control-IQ Technology11 models · 126,966 reports · 3 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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