t:flex Insulin Pump, Replacement, Refurbished 007473Recalls & reported problems
Tandem Diabetes Care, Inc. · Assembly, Pump Replacement, Refurbished, t:flex · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Tandem t:flex insulin pump is a refurbished replacement pump used to deliver insulin. Its 2,373 reports often describe the pump stopping, inaccurate insulin readings, blocked flow, and battery or charging problems, and mention 201 injuries and 2 deaths. They also mention high or low blood sugar, and in some cases elevated ketones. 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
- 2,373
- Deaths reported
- 2
- Injuries reported
- 201
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,373 adverse event reports that list this exact device (DI 00852162004569), received between Jul 9, 2018 and Jan 8, 2025 — classified as 2 deaths, 201 injuries, 2,170 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (458 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement458
- Pumping Stopped430
- Obstruction of Flow345
- Charging Problem253
- Battery Problem250
- Failure to Sense145
- False Alarm138
- Adverse Event Without Identified Device or Use Problem113
Patient problems
- No Consequences Or Impact To Patient1,045
- No Clinical Signs, Symptoms or Conditions614
- No Known Impact Or Consequence To Patient521
- Hyperglycemia120
- Hypoglycemia76
- Elevated Ketones/ Diabetic Ketoacidosis22
- Dizziness3
- Death2
Recent adverse event reports
The 25 most recent of 2,373 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 8, 2025Overheating of Device; Device Sensing Problem; Overheating of Device; Device Sensing Problem
IT WAS REPORTED THAT THE PUMP WAS WARM TO THE TOUCH DESPITE BEING IN ROOM-TEMPERATURE CONDITIONS. REPORTEDLY, THE PUMP WAS CHARGING DURING THE EVENT. ADDITIONALLY, IT WAS REPORTED THAT THE WAKE BUTTON WAS NOT WORKING. 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 21103984 ↗MalfunctionNov 6, 2024Pumping Stopped; Failure to Sense; Battery Problem; Pumping Stopped; Failure to Sense; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY RESULTING IN THE PUMP SHUTTING OFF. ADDITIONALLY, THE PUMP TOUCHSCREEN WAS UNRESPONSIVE. 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 20620199 ↗MalfunctionSep 24, 2024Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED. CUSTOMER DECLINED FOLLOW UP FROM TANDEM TECHNICAL SUPPORT. REPORTEDLY THE CUSTOMER IS USING U-500 INSULIN. THERE WAS NO REPORTED ADVERSE IMPACT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20296589 ↗InjurySep 23, 2024Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL. AT THE TIME OF THE REPORT, THE CUSTOMER HAD NOT ADDRESSED BG LEVEL AND WENT TO THE EMERGENCY ROOM. MULTIPLE ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO FOLLOW-UP WITH THE CUSTOMER; HOWEVER, NO RESPONSE WAS RECEIVED, AND NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED.
Patient problems: Hyperglycemia
MAUDE report 20287563 ↗MalfunctionSep 11, 2024Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT THE PUMP SHUT OFF UNEXPECTEDLY. THE CUSTOMER DECLINED FURTHER TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THEREFORE NO ADDITIONAL INFORMATION COULD BE OBTAINED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20189119 ↗MalfunctionAug 23, 2024Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT AN UNSPECIFIED MALFUNCTION ALARM OCCURRED. REPORTEDLY, THE CUSTOMER CONTACTED THE HEALTHCARE PROVIDER TO OBTAIN ALTERNATE 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 20051954 ↗MalfunctionAug 22, 2024Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. 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 20035277 ↗MalfunctionAug 9, 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 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 19954448 ↗MalfunctionAug 5, 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 REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19913071 ↗MalfunctionAug 5, 2024Charging Problem; Charging Problem
IT WAS REPORTED THAT THE CUSTOMER RECEIVED A POWER SOURCE ALERT AFTER PLUGGING THE PUMP INTO A WALL OUTLET. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE ALERT CLEARED, AND THE PUMP SUCCESSFULLY BEGAN CHARGING AFTER LEAVING THE PUMP PLUGGED INTO THE POWER SOURCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19911345 ↗MalfunctionJul 19, 2024Filling Problem; Incorrect Measurement; Battery Problem; Filling Problem; Incorrect Measurement; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY, THE INSULIN GAUGE WAS INACCURATE, AND A MINIMUM FILL NOTIFICATION OCCURRED. 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 19785023 ↗MalfunctionJun 6, 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 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 19477225 ↗MalfunctionMay 20, 2024Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED. 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 19353227 ↗MalfunctionMay 15, 2024Charging Problem; Charging Problem
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 19320551 ↗MalfunctionApr 26, 2024Battery Problem; Battery Problem
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 19191878 ↗MalfunctionApr 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. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE CUSTOMER DECLINED FURTHER TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19143541 ↗MalfunctionMar 18, 2024Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. 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 18921362 ↗MalfunctionMar 15, 2024Failure to Sense; Battery Problem; Failure to Sense; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY AND THAT THE PUMP TOUCHSCREEN 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 18913022 ↗MalfunctionFeb 13, 2024Battery 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 18697991 ↗MalfunctionFeb 9, 2024Charging Problem; Charging Problem
IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO CHARGE THE PUMP USING THE TANDEM-PROVIDED WALL POWER ADAPTER. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER WAS ABLE TO SUCCESSFULLY CHARGE THE PUMP USING A SECONDARY WALL POWER ADAPTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18678361 ↗MalfunctionFeb 9, 2024Incorrect Measurement; Battery Problem; Device Sensing Problem; Incorrect Measurement; Battery Problem; Device Sensing Problem
IT WAS REPORTED THAT THE WAKE BUTTON WAS STICKING, THE INSULIN GAUGE WAS INACCURATE AND THE PUMP BATTERY WAS DEPLETING QUICKLY. 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 18675405 ↗MalfunctionJan 18, 2024Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18537664 ↗MalfunctionDec 14, 2023Overheating of Device; Date/Time-Related Software Problem; Battery Problem; Overheating of Device; Date/Time-Related Software Problem; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP CLOCK "LOSES" TIME. IT WAS ALSO REPORTED THAT THE PUMP WAS WARM TO THE TOUCH DESPITE BEING IN ROOM-TEMPERATURE CONDITIONS. REPORTEDLY, THE PUMP WAS CHARGING DURING THE EVENT. 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 18324218 ↗MalfunctionNov 3, 2023Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS ¿NOT ILLUMINATING FULLY¿. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE. REPORTEDLY, THE CUSTOMER DECLINED TO PROVIDE ADDITIONAL INFORMATION, AND DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18064681 ↗MalfunctionNov 2, 2023Incorrect Measurement; Date/Time-Related Software Problem; Incorrect Measurement; Date/Time-Related Software Problem
IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE AND THAT THE PUMP TIME WAS INCORRECT, CAUSE WAS UNKNOWN. 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 18056713 ↗
Other Pump, Infusion, Insulin devices
- Omnipod DASH Pod POD-BLE-11-520Insulet Corporation · Pump, Infusion, Insulin1 recall30 deaths56,209 reports
- Omnipod ZXP420Insulet Corporation · Pump, Infusion, Insulin1 recall17 deaths37,832 reports
- Omnipod ZXP420Insulet Corporation · Pump, Infusion, Insulin70 deaths20,092 reports
- t:slim X2 Insulin Pump 1000103Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin1 recall1 death7,327 reports
- t:slim Insulin Pump, Reconditioned Replacement 007262Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin2 deaths5,253 reports
- t:slim Insulin Pump 007435Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin7 deaths2,104 reports
- Accu-Chek Combo 05027250001Roche Diabetes Care GmbH · Pump, Infusion, Insulin1,830 reports
- t:slim X2 Insulin Pump 1000369Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin1 recall1,640 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 16, 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