t:slim X2 Insulin PumpRecalls & reported problems across all models
Tandem Diabetes Care, Inc. · 45 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
4 open recalls name at least one t:slim X2 Insulin Pump model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 897,233
- Deaths reported
- 141
- Injuries reported
- 95,712
- Recalls
- 4
We found 45 models of t:slim X2 Insulin Pump by Tandem Diabetes Care, Inc. in the FDA's device registry (GUDID). Together they are named in 897,233 adverse event reports in the FDA's MAUDE database, received between Mar 6, 2017 and Sep 30, 2026 — classified as 141 deaths, 95,712 injuries, 801,380 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (256,346 reports).
4 FDA recall records name at least one of these models by its device identifier, 4 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 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, 2025Open, 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, 2025Open, 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 21 of these models · Recall details · FDA record ↗
- Feb 27, 2025Open, 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 ↗
- May 24, 2022Open, 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 26 of these models · Recall details · FDA record ↗
Most reported t:slim X2 Insulin Pump problems
Device problems
- Pumping Stopped256,346
- Incorrect Measurement92,522
- Charging Problem90,000
- Battery Problem69,844
- Obstruction of Flow61,581
- Adverse Event Without Identified Device or Use Problem54,749
- Failure to Sense44,510
- Communication or Transmission Problem42,021
Patient problems
- No Clinical Signs, Symptoms or Conditions677,921
- No Consequences Or Impact To Patient91,890
- Hyperglycemia61,029
- No Known Impact Or Consequence To Patient32,665
- Hypoglycemia31,886
- Elevated Ketones/ Diabetic Ketoacidosis6,561
- Insufficient Information1,994
- Loss of consciousness1,342
t:slim X2 Insulin Pump models
45 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 Basal-IQ 1000886Automated Insulin Dosing , Threshold Suspend1 recall17 deaths108,656 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 Technology 1013198Alternate Controller Enabled Insulin Infusion Pump1 recall8 deaths47,637 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 Technology 1013195Alternate Controller Enabled Insulin Infusion Pump1 recall7 deaths30,344 reports
- t:slim X2 Insulin Pump with Basal-IQ 1000912Automated Insulin Dosing , Threshold Suspend1 recall2 deaths30,219 reports
- t:slim X2 Insulin Pump with Control-IQ 1009641Alternate Controller Enabled Insulin Infusion Pump1 recall8 deaths25,864 reports
- t:slim X2 5.0 Insulin Pump 1000885Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor1 recall2 deaths17,224 reports
- t:slim X2 Insulin Pump with Basal-IQ 1006379Alternate Controller Enabled Insulin Infusion Pump2 recalls16,712 reports
- t:slim X2 Insulin Pump with Basal-IQ 1000898Automated Insulin Dosing , Threshold Suspend1 recall6 deaths16,106 reports
- t:slim X2 5.0 Insulin Pump 1000911Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor2 recalls2 deaths15,928 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 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 Basal-IQ 1006373Alternate Controller Enabled Insulin Infusion Pump1 recall7,488 reports
- t:slim X2 Insulin Pump 1000103Pump, Infusion, Insulin1 recall1 death7,327 reports
- t:slim X2 5.0 Insulin Pump 1000897Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor1 recall2 deaths6,444 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 Basal-IQ 1000892Automated Insulin Dosing , Threshold Suspend1 recall1 death5,216 reports
- t:slim X2 Insulin Pump with Control-IQ 1005013Alternate Controller Enabled Insulin Infusion Pump1 recall5,097 reports
- t:slim X2 Insulin Pump with Basal-IQ 1005706Automated Insulin Dosing , Threshold Suspend1 recall2 deaths5,094 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 1005012Interoperable Automated Glycemic Controller1 recall4,129 reports
- t:slim X2 Insulin Pump with Control-IQ+ Technology 1014071Alternate Controller Enabled Insulin Infusion Pump1 recall2 deaths3,154 reports
- t:slim X2 5.x Insulin Pump 1003808Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor2 recalls1 death2,526 reports
- t:slim X2 Insulin Pump 1000369Pump, Infusion, Insulin1 recall1,640 reports
- t:slim X2 5.0 Insulin Pump 1000891Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor1 recall1,561 reports
- t:slim X2 Insulin Pump with Basal-IQ 1009636Alternate Controller Enabled Insulin Infusion Pump1 recall1,403 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 Basal-IQ 1005698Automated Insulin Dosing , Threshold Suspend1 recall1,316 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 Basal-IQ 1006375Alternate Controller Enabled Insulin Infusion Pump1 recall1,016 reports
- t:slim X2 Insulin Pump with Control-IQ Technology 1012869Alternate Controller Enabled Insulin Infusion Pump1 recall892 reports
- t:slim X2 Insulin Pump with Basal-IQ 1009640Alternate Controller Enabled Insulin Infusion Pump1 recall765 reports
- t:slim X2 Insulin Pump with Basal-IQ 1006377Alternate Controller Enabled Insulin Infusion Pump1 recall520 reports
- t:slim X2 Insulin Pump with Basal-IQ 1009638Alternate Controller Enabled Insulin Infusion Pump1 recall458 reports
- t:slim X2 Pump, Replacement, Refurb. 1000353Pump, Infusion, Insulin1 recall320 reports
- t:slim X2 5.0 Insulin Pump 1003487Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor1 recall84 reports
- t:slim X2 Insulin Pump with Basal-IQ 1009639Alternate Controller Enabled Insulin Infusion Pump1 recall68 reports
Recent t:slim X2 Insulin Pump 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, 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, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954999 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954995 ↗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, 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 50954974 ↗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 ↗
Other Tandem Diabetes Care, Inc. products
- 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
- 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, combining the brand names used for this product line.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 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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