t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM 006194Recalls & reported problems
Tandem Diabetes Care, Inc. · The #1-rated insulin pump is now integrated with the #1-rated Continuous Glucose Monitoring brand that set the standard for accuracy and performance in sensor-augmented pumps. The t:slim G4 Pump is the only pump that conveniently combines CGM graphs and trend information with current insulin delivery together on a single color touch screen to help you make more informed decisions. · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Tandem t:slim G4 insulin pump, which works with a Dexcom glucose monitor, delivers insulin. Its 2,272 reports often describe the pump stopping, battery and charging problems, and inaccurate readings, and mention 167 injuries and 4 deaths. Some describe unresponsive touch screens. No recalls name this device.
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
- 2,272
- Deaths reported
- 4
- Injuries reported
- 167
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,272 adverse event reports that list this exact device (DI 00852162004408), received between May 23, 2016 and Sep 17, 2025 — classified as 4 deaths, 167 injuries, 2,100 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (550 reports).
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
Most reported problems
Device problems
- Pumping Stopped550
- Battery Problem363
- Device Sensing Problem301
- Incorrect Measurement285
- Charging Problem239
- Obstruction of Flow220
- Failure to Sense162
- Adverse Event Without Identified Device or Use Problem86
Patient problems
- No Consequences Or Impact To Patient1,133
- No Known Impact Or Consequence To Patient742
- No Clinical Signs, Symptoms or Conditions211
- Hyperglycemia95
- Hypoglycemia49
- Elevated Ketones/ Diabetic Ketoacidosis33
- No Patient Involvement22
- Insufficient Information9
Recent adverse event reports
The 25 most recent of 2,272 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE SYSTEM WAS UNABLE TO ACCURATELY READ THE CARTRIDGE'S CAPACITY, CAUSING THE PATIENT TO LOAD EXCESS INSULIN WHICH RESULTED IN WASTAGE. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED FURTHER TROUBLESHOOTING AND NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE OUTCOME OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23076500 ↗MalfunctionJul 11, 2025Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem
CUSTOMER REPORTED DIFFICULTY IN HEARING ALARMS ON THEIR DEVICE, AS THE VOLUME WAS TOO FAINT EVEN WHEN SET AT THE MAXIMUM LEVEL. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER IS CURRENTLY OUT OF WARRANTY AND IS IN THE PROCESS OF OBTAINING A NEW DEVICE. THEY DECLINED FOLLOW-UP FROM CUSTOMER TECHNICAL SUPPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22479505 ↗MalfunctionDec 13, 2024Pumping 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 20929437 ↗MalfunctionNov 22, 2024Charging Problem; Charging Problem
IT WAS REPORTED THAT THE PUMP'S USB PORT WAS DAMAGED RESULTING IN DIFFICULTIES CHARGING THE PUMP. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE. NO ADDITIONAL INFORMATION WAS PROVIDED AND THE CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20764947 ↗MalfunctionOct 17, 2024Incorrect Measurement; Pumping Stopped; Charging Problem; Incorrect Measurement; Pumping Stopped; Charging Problem
IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING RESULTING IN PUMP SHUTTING DOWN AND THE PUMP BATTERY COULD NOT BE CHARGED. THERE WAS NO ADVERSE IMPACT TO 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 20471094 ↗MalfunctionOct 14, 2024Failure to Sense; Fitting Problem; Battery Problem; Failure to Sense; Fitting Problem; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE, AND UNDEFINED CARTRDIGE LOADING ISSUES. 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 20440321 ↗MalfunctionSep 18, 2024Failure to Sense; Failure to Sense
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS DELAYED IN RESPONDING TO PRESSES. 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 20248623 ↗MalfunctionSep 5, 2024Failure to Sense; Failure to Sense
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE. THERE WAS NO REPORTED 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 20145547 ↗MalfunctionAug 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PUMP ¿WILL NOT POWER ON¿. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT AND DECLINED TO PROVIDE FURTHER INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20050612 ↗MalfunctionAug 21, 2024Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED OCCLUSION ALARMS OCCURRED. CUSTOMER DECLINED FOLLOW UP FROM TANDEM TECHNICAL SUPPORT. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20009231 ↗MalfunctionAug 8, 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 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 19946100 ↗MalfunctionJul 12, 2024Incorrect Measurement; Battery Problem; Incorrect Measurement; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. ADDITIONALLY, IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. 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 19729297 ↗MalfunctionJun 24, 2024Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. THE CUSTOMER DECLINED FURTHER TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THEREFORE NO ADDITIONAL INFORMATION COULD BE OBTAINED. THERE WAS NO REPORTED ADVERSE IMPACT ON CUSTOMER'S BLOOD GLUCOSE LEVEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19601234 ↗MalfunctionJun 11, 2024Failure to Sense; Failure to Sense
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE. 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 19510126 ↗MalfunctionJun 8, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT OUT OF RANGE ISSUES OCCURRED BETWEEN THE TRANSMITTER AND PUMP GREATER THAN 15 MINUTES, WITH NO CONTINUOUS GLUCOSE MONITOR (CGM) SENSOR READINGS. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. 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 19494759 ↗MalfunctionApr 23, 2024Failure to Sense; Failure to Sense
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE. 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 19166542 ↗MalfunctionApr 8, 2024No Audible Alarm; No Audible Alarm
IT WAS REPORTED THAT THE PUMP'S ALARM VOLUME WAS TOO LOW. THE CUSTOMER'S BLOOD GLUCOSE LEVEL HAD NO REPORTED IMPACT. REPORTEDLY, THE CUSTOMER CONTINUED USING CURRENT PUMP FOR INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19059908 ↗MalfunctionApr 2, 2024Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT AN UNSPECIFIED MALFUNCTION ALARM OCCURRED. CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT AND DECLINED TO PROVIDE FURTHER INFORMATION. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19020625 ↗MalfunctionFeb 21, 2024Partial Blockage; Date/Time-Related Software Problem; Partial Blockage; Date/Time-Related Software Problem
IT WAS REPORTED THAT THE PUMP TIME WAS INCORRECT, AND A BLOCKAGE CAUSE WAS UNKNOWN. 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 18748769 ↗MalfunctionFeb 2, 2024Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY INTERMITTENTLY. THERE WAS NO REPORTED ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVELS. CUSTOMER DECLINED TROUBLESHOOTING. NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18630863 ↗MalfunctionJan 24, 2024Pumping Stopped; Battery Problem; Charging Problem; Pumping Stopped; Battery Problem; Charging Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY RESULTING IN THE PUMP SHUTTING OFF. ADDITIONALLY, IT AS REPORTED THAT THE PUMP'S USB PORT WAS DAMAGED RESULTING IN DIFFICULTIES CHARGING THE PUMP. 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 18570369 ↗MalfunctionJan 3, 2024Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. THERE WAS NO REPORTED ADVERSE EFFECT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED TO TROUBLESHOOT THE ISSUE WITH TANDEM TECHNICAL SUPPORT; THEREFORE THE ALLEGATION COULD NOT BE CONFIRMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18434551 ↗MalfunctionDec 26, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. THERE WAS NO REPORTED ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVELS. CUSTOMER DECLINED TROUBLESHOOTING. NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18392389 ↗MalfunctionDec 19, 2023Charging 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 CUSTOMER'S BLOOD GLUCOSE LEVEL. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE CUSTOMER DECLINED FURTHER TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18355353 ↗MalfunctionDec 18, 2023Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING. 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 18344160 ↗
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
- 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
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page