t:slim X2 5.x Insulin Pump 1003808Recalls & reported problems
Tandem Diabetes Care, Inc. · t:slim X2 5.x Insulin Pump, Replacement, Refurbished · Class 3
All models of t:slim X2 Insulin Pump (45)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Tandem t:slim X2 insulin pump has 2,525 adverse event reports, including 1 death and 208 injuries. Many reports describe the pump stopping, battery drain and trouble sensing, and many note no impact on the patient. Two recalls are open: one over speakers that can fail, silencing alerts and stopping insulin, and one over software issues that an update can address. Reports fell to 4 in the last 12 months from 11 in the 12 months before.
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
- 2,526
- Deaths reported
- 1
- Injuries reported
- 208
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 2,526 adverse event reports that list this exact device (DI 00853052007981), received between Dec 7, 2018 and Sep 25, 2026 — classified as 1 death, 208 injuries, 2,317 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (522 reports).
2 FDA recall records name this device's identifier, 2 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
- 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 · 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Pumping Stopped522
- Battery Problem489
- Failure to Sense314
- Obstruction of Flow282
- Incorrect Measurement249
- Charging Problem199
- Adverse Event Without Identified Device or Use Problem122
- Device Sensing Problem121
Patient problems
- No Consequences Or Impact To Patient915
- No Known Impact Or Consequence To Patient724
- No Clinical Signs, Symptoms or Conditions689
- Hyperglycemia112
- Hypoglycemia81
- Elevated Ketones/ Diabetic Ketoacidosis21
- Insufficient Information6
- Fall2
Recent adverse event reports
The 25 most recent of 2,526 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Failure to Charge
It was reported that the pump battery could not be charged. 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 50896334 ↗MalfunctionAug 7, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50176170 ↗MalfunctionJul 1, 2026Pumping Stopped
IT WAS REPORTED THAT THE PUMP EXPERIENCED A MALFUNCTION. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER. THE CUSTOMER DID NOT HAVE AN ALTERNATE METHOD OF INSULIN THERAPY AVAILABLE. REPORTEDLY, THE CUSTOMER WOULD REACH OUT TO THEIR HCP TO OBTAIN A BACKUP METHOD OF INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25683525 ↗MalfunctionApr 23, 2026Premature Discharge of Battery
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED TO TROUBLESHOOT WITH TANDEM TECHNICAL SUPPORT, THEREFORE NO ADDITIONAL INFORMATION COULD BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24965073 ↗MalfunctionMar 17, 2026Premature Discharge of Battery
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. 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 24621831 ↗MalfunctionAug 8, 2025Premature Discharge of Battery; Premature Discharge of Battery
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 FURTHER TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT; THEREFORE NO ADDITIONAL INFORMATION COULD BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22751663 ↗MalfunctionJul 31, 2025Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. CUSTOMER DECLINED FOLLOW UP FROM TANDEM TECHNICAL SUPPORT. THERE WAS NO REPORTED ADVERSE IMPACT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22679294 ↗MalfunctionMay 15, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. CUSTOMER DECLINED FOLLOW UP FROM TANDEM TECHNICAL SUPPORT. THERE WAS NO REPORTED ADVERSE IMPACT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22024766 ↗MalfunctionMay 2, 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 21951099 ↗MalfunctionMar 26, 2025Insufficient 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. MULTIPLE CONTACT ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE ISSUE; HOWEVER, THE CUSTOMER DID NOT RESPOND. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21704336 ↗MalfunctionMar 25, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PUMP RESET UNEXPECTEDLY. CUSTOMER RESUMED INSULIN DELIVERY SUCCESSFULLY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21687858 ↗MalfunctionJan 22, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. 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 21211086 ↗MalfunctionJan 17, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT CARTRIDGE CHANGE ERRORS OCCURRED WITH MULTIPLE CARTRIDGES DURING THE LOAD SEQUENCE. CUSTOMER REVERTED TO AN ALTERNATE FORM OF INSULIN THERAPY. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21183918 ↗MalfunctionDec 9, 2024False Alarm; False Alarm
IT WAS REPORTED THAT THE PUMP WAS NOT EXPOSED TO EXTREME TEMPERATURES, BUT A TEMPERATURE ALARM OCCURRED. CUSTOMER WAS UNABLE TO CLEAR THE ALARM AND 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 20881110 ↗MalfunctionNov 9, 2024Incorrect Measurement; Charging Problem; Incorrect Measurement; Charging Problem
IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP USB PORT WAS DAMAGED RESULTING IN DIFFICULTIES CHARGING THE PUMP. 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 20647032 ↗MalfunctionNov 4, 2024Charging Problem; Charging Problem
IT WAS REPORTED THAT THE PUMP'S USB PORT WAS DAMAGED RESULTING IN DIFFICULTIES CHARGING 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. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20605616 ↗MalfunctionOct 22, 2024Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. 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 20502156 ↗MalfunctionOct 14, 2024Charging Problem; Charging Problem
IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20439682 ↗MalfunctionOct 12, 2024Pumping Stopped; Battery Problem; Insufficient Device Problem Information; Pumping Stopped; Battery Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY RESULTING IN THE PUMP SHUTTING DOWN. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A CARTRIDGE. THERE WAS NO REPORTED 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 20434925 ↗InjuryOct 10, 2024Loose or Intermittent Connection; Charging Problem; Loose or Intermittent Connection; Charging Problem
IT WAS REPORTED THAT THE PUMP'S USB PORT HAS A LOOSE CONNECTION AND UNSTABLE/NOT RECOGNIZED AND THE PUMP BATTERY INTERMITTENTLY COULD NOT BE CHARGED PROPERLY. IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ELEVATED BLOOD GLUCOSE (BG) LEVEL. THE CONTINUOUS GLUCOSE MONITOR READ ¿HIGH¿; HOWEVER, A SPECIFIC BG VALUE WAS NOT PROVIDED. THE CUSTOMER REQUIRED ASSISTANCE ADDRESSING BG LEVEL WITH A MANUAL INSULIN INJECTION. REPORTEDLY, THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.
Patient problems: Hyperglycemia
MAUDE report 20424758 ↗MalfunctionOct 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PUMP WAS NOT WORKING PROPERLY. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE. NO ADDITIONAL INFORMATION WAS PROVIDED. MULTIPLE ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, THE CUSTOMER DID NOT RESPOND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20421107 ↗MalfunctionOct 10, 2024Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT AN UNSPECIFIED MALFUNCTION ALARM OCCURRED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER. MULTIPLE ATTEMPTS WERE MADE BY TANDEM¿S TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20418160 ↗MalfunctionOct 7, 2024Crack; Poor Quality Image; Battery Problem; Crack; Poor Quality Image; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS CRACKED AND DIFFICULT TO READ. CUSTOMER DECLINED FOLLOW UP FROM TANDEM TECHNICAL SUPPORT. THERE WAS NO REPORTED ADVERSE IMPACT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20384092 ↗MalfunctionSep 28, 2024Poor Quality Image; Failure to Sense; Battery Problem; Poor Quality Image; Failure to Sense; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS PIXELATED AND 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 20328767 ↗InjurySep 25, 2024Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT AN UNSPECIFIED 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: Hyperglycemia
MAUDE report 20301857 ↗
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 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
- t:slim X2 5.0 Insulin Pump 1000891Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor1 recall1,561 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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