t:slim X2 5.0 Insulin Pump 1000891Recalls & reported problems
Tandem Diabetes Care, Inc. · t:slim X2 5.0 Insulin Pump, Replacement · Class 3
All models of t:slim X2 Insulin Pump (45) · t:slim X2 5.0 Insulin Pump (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Tandem t:slim X2 is an insulin pump. Its 1,561 reports describe many cases of the pump stopping, charging and battery problems, and wrong measurements, and some describe blocked flow. The reports include 123 injuries and no deaths. There is 1 recall, still open, which started in May 2022 and concerns software problems that could lead to blood sugar running high or low.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,561
- Deaths reported
- 0
- Injuries reported
- 123
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1,561 adverse event reports that list this exact device (DI 00853052007271), received between Jul 9, 2018 and Aug 7, 2026 — classified as 123 injuries, 1,438 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (287 reports).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (P140015); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Pumping Stopped287
- Charging Problem220
- Battery Problem211
- Incorrect Measurement211
- Obstruction of Flow186
- Failure to Sense101
- Adverse Event Without Identified Device or Use Problem77
- False Alarm76
Patient problems
- No Consequences Or Impact To Patient664
- No Clinical Signs, Symptoms or Conditions622
- No Known Impact Or Consequence To Patient158
- Hyperglycemia60
- Hypoglycemia51
- Elevated Ketones/ Diabetic Ketoacidosis15
- Insufficient Information4
- No Patient Involvement2
Recent adverse event reports
The 25 most recent of 1,561 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50177473 ↗MalfunctionJul 6, 2026Pumping Stopped
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. DURING TROUBLESHOOTING WITH TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED, AND INSULIN DELIVERY WAS RESUMED SUCCESSFULLY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25716999 ↗MalfunctionJun 4, 2026Mechanical Problem
IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING THE LOAD SEQUENCE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25399276 ↗MalfunctionApr 9, 2026Premature Discharge of Battery
IT WAS REPORTED THAT CUSTOMER EXPERIENCED BATTERY DEPLETION ISSUE WITH PUMP. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED FURTHER FOLLOW-UP AND NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE OUTCOME OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24837599 ↗MalfunctionNov 5, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THE CUSTOMER WAS EXPERIENCING UNSPECIFIED ISSUES WITH THE RESPONSIVENESS OF THE WAKE BUTTON ON THE PUMP. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED TO TROUBLESHOOT THE ISSUE WITH TANDEM TECHNICAL SUPPORT, THEREFORE NO ADDITIONAL INFORMATION WAS OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476760 ↗MalfunctionNov 5, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE. CUSTOMER DECLINED FOLLOW UP FROM TANDEM TECHNICAL SUPPORT. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23473051 ↗MalfunctionAug 22, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT CARTRIDGE CHANGE ERRORS OCCURRED WITH MULTIPLE CARTRIDGES. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY THE CUSTOMER CONTINUED TO USE PUMP FOR INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22876879 ↗MalfunctionAug 22, 2025Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem
PATIENT REPORTED EXPERIENCING MULTIPLE CARTRIDGE LOAD ERRORS WITH THEIR CURRENT DEVICE, CAUSING THEM TO GO THROUGH SEVERAL CARTRIDGES BEFORE FINDING ONE THAT WORKS. THERE WAS NO ADVERSE IMPACT TO THE PATIENT¿S BLOOD GLUCOSE LEVEL. THE PATIENT DECLINED FURTHER ASSISTANCE FROM TECHNICAL SUPPORT AS THEY ARE IN THE PROCESS OF RENEWING THEIR DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22873050 ↗MalfunctionJul 13, 2025Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. THERE WAS NO ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22490634 ↗MalfunctionJul 10, 2025Mechanical Problem; Mechanical Problem
A CARTRIDGE CHANGE ERROR WAS REPORTED WITH THE PUMP. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL, AS IT DID NOT EXCEED 500 MG/DL (27.7 MMOL/L). THE CUSTOMER FOLLOWED INSTRUCTIONS FROM TECHNICAL SUPPORT TO REMOVE THE CARTRIDGE AND INSPECT THE O-RING, AND THEN CLEANED THE PNEUMATIC TAP AREA OF THE PUMP. DESPITE THESE EFFORTS, A MALFUNCTION OCCURRED, AND THE PUMP COULD NOT BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22468601 ↗MalfunctionJun 7, 2025Failure to Sense; Failure to Sense
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE. THERE WAS NO ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22163692 ↗MalfunctionApr 29, 2025Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21928270 ↗MalfunctionMar 17, 2025Incorrect Measurement; Battery Problem; Incorrect Measurement; Battery Problem
IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED FOLLOW-UP TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THEREFORE NO ADDITIONAL INFORMATION COULD BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21618230 ↗MalfunctionMar 7, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT THE CUSTOMER RECEIVED A CONTINUOUS GLUCOSE MONITOR ERROR 42. THE PUMP WAS RESET, AND THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21552037 ↗MalfunctionJan 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A CARTRIDGE DID NOT FIT ONTO THE PUMP. REPORTEDLY, THERE WAS AN O-RING FROM A PREVIOUS CARTRIDGE ON THE PNEUMATIC TAP. THE CUSTOMER REMOVED THE O-RING AND SUCCESSFULLY LOADED THE CARTRIDGE TO ADDRESS THE EVENT. THERE WAS NO ADVERSE IMPACT TO CUSTOMER'S BLOOD GLUCOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21134897 ↗MalfunctionNov 19, 2024Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20719891 ↗MalfunctionNov 11, 2024Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20652353 ↗MalfunctionNov 7, 2024Incorrect Measurement; Pumping Stopped; Incorrect Measurement; Pumping Stopped
IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING RESULTING IN THE PUMP SHUTTING DOWN. ADDITIONALLY, THE INSULIN GAUGE WAS INACCURATE AND STATIC. THERE WAS NO ADVERSE IMPACT TO CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED ASSISTANCE FROM TANDEM TECHNICAL SUPPORT REGARDING THE ISSUES. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20629413 ↗MalfunctionOct 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE CUSTOMER HAD AN UNSPECIFIED CARTRIDGE ISSUE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED FOLLOW-UP FROM TANDEM TECHNICAL SUPPORT REGARDING THE ISSUE, THEREFORE NO ADDITIONAL INFORMATION WAS OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20482044 ↗MalfunctionOct 15, 2024Battery Problem; Charging Problem; Battery Problem; Charging Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. ADDITIONALLY, THE PUMP BATTERY WAS REPORTED CHARGING INCONSISTENTLY. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED ASSISTANCE FROM TANDEM TECHNICAL SUPPORT REGARDING THE ISSUES. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20449954 ↗MalfunctionOct 7, 2024Failure to Sense; Battery Problem; Charging Problem; Failure to Sense; Battery Problem; Charging Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY AND WAS TAKING LONGER TO CHARGE. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP USB PORT WAS DAMAGED RESULTING IN DIFFICULTIES CHARGING THE PUMP. IT WAS ALSO REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. NO ADDITIONAL INFORMATION WAS PROVIDED AND THE CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20392697 ↗MalfunctionSep 13, 2024Charging Problem; Charging Problem
IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED, POSSIBLY DUE TO "BEING WASHED.". THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20215565 ↗MalfunctionAug 28, 2024Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. DURING TROUBLESHOOTING WITH TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED, AND INSULIN DELIVERY WAS RESUMED SUCCESSFULLY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20086420 ↗MalfunctionAug 27, 2024Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT AN UNSPECIFIED MALFUNCTION ALARM OCCURRED. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED FOLLOW-UP TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THEREFORE NO ADDITIONAL INFORMATION COULD BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20077181 ↗MalfunctionJun 18, 2024Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. DURING TROUBLESHOOTING WITH TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED, AND INSULIN DELIVERY WAS RESUMED SUCCESSFULLY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19558393 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P140015. One submission often covers many models, so check the product and lot details in each record.
- Z-2471-2018 · Apr 23, 2018 · Open, Classifiedt:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B.
Other Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor devices
- t:slim X2 5.0 Insulin Pump 1000885Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor1 recall2 deaths17,224 reports
- t:slim X2 5.0 Insulin Pump 1000911Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor2 recalls2 deaths15,928 reports
- t:slim X2 5.0 Insulin Pump 1000897Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor1 recall2 deaths6,444 reports
- t:slim X2 5.x Insulin Pump 1003808Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor2 recalls1 death2,526 reports
- t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM 006194Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor4 deaths2,272 reports
- Animas Vibe 11451100Animas Corporation · Pump, infusion, insulin, to be used with invasive glucose sensor2 deaths2,262 reports
- Animas Vibe 11451000Animas Corporation · Pump, infusion, insulin, to be used with invasive glucose sensor1,122 reports
- Animas Vibe 11451200Animas Corporation · Pump, infusion, insulin, to be used with invasive glucose sensor1,064 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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