t:flex Insulin Pump, Reconditioned 007666Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 00852162004606), received between Jul 9, 2018 and Jan 9, 2023 — classified as 6 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (16 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2023Pumping 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 222 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16126316 ↗
• MalfunctionFeb 14, 2022Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING BASAL DELIVERY. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER CLEARED THE ALARM AND RESUMED INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13524133 ↗
• MalfunctionNov 10, 2021Battery 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. CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT AND DECLINED TO PROVIDE FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787611 ↗
• MalfunctionOct 7, 2021Pumping Stopped; Date/Time-Related Software Problem; Pumping Stopped; Date/Time-Related Software Problem

  IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP TIME WAS INCORRECT, CAUSE WAS UNKNOWN. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED, AND INSULIN DELIVERY WAS RESUMED SUCCESSFULLY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 278 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12594466 ↗
• MalfunctionSep 14, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. CUSTOMER LOADED A NEW CARTRIDGE TO RESOLVE THE ISSUE WITH MULTIPLE CARTRIDGES. THERE WAS NO ADVERSE IMPACT ON CUSTOMER'S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12467839 ↗
• MalfunctionSep 7, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. THERE WAS NO REPORTED IMPACT TO BLOOD GLUCOSE. CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12434338 ↗
• MalfunctionAug 31, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED. THERE WAS NO REPORTED ADVERSE IMPACT. NO ADDITIONAL INFORMATION WAS PROVIDED. CUSTOMER DECLINED FOLLOW UP FROM TANDEM TECHNICAL SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12392839 ↗
• MalfunctionAug 4, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUE AND RESUMED INSULIN DELIVERY. THERE WAS NO ADVERSE IMPACT TO CUSTOMER'S BLOOD GLUCOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12275909 ↗
• MalfunctionMay 27, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING. THE CUSTOMER'S BLOOD GLUCOSE WAS 105 MG/DL. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11893939 ↗
• MalfunctionMar 4, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER CLEARED THE ALARM OR CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUE AND RESUMED INSULIN DELIVERY. CUSTOMER'S BLOOD GLUCOSE WAS 200 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11415174 ↗
• MalfunctionFeb 25, 2021Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE CUSTOMER HAD BEEN EXPERIENCING DIFFICULTY CHARGING THE PUMP WITH THE WALL ADAPTER. THE PUMP WAS ABLE TO BE CHARGED WITH AN ALTERNATE WALL ADAPTER. THE CUSTOMER¿S BLOOD GLUCOSE WAS 126(MG/DL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11377867 ↗
• MalfunctionFeb 5, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. CUSTOMER CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUE AND RESUMED INSULIN DELIVERY. THERE WAS NO REPORTED ADVERSE IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11286419 ↗
• MalfunctionNov 20, 2020Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 360 MG/DL. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10875626 ↗
• MalfunctionNov 17, 2020Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE WAKE BUTTON WAS UNRESPONSIVE. CUSTOMER CONFIRMED PUMP DISPLAY TURNED ON WHEN PLUGGED INTO A POWER SOURCE. CUSTOMER¿S BLOOD GLUCOSE WAS 228 MG/DL. REPORTEDLY, CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10855939 ↗
• MalfunctionOct 22, 2020Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE WAKE BUTTON WAS UNRESPONSIVE. CUSTOMER CONFIRMED PUMP DISPLAY TURNED ON WHEN PLUGGED INTO A POWER SOURCE. THERE WAS NO REPORTED IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER WILL CONTINUE TO USE CURRENT PUMP, AND HAS MANUAL INJECTIONS AVAILABLE FOR INSULIN THERAPY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10718829 ↗
• MalfunctionSep 18, 2020Pumping Stopped; Visual Prompts will not Clear; Pumping Stopped; Visual Prompts will not Clear

  IT WAS REPORTED THAT MULTIPLE CARTRIDGE ALARMS (ALARM 1) OCCURRED WITH MULTIPLE CARTRIDGES DURING BASAL DELIVERIES. CUSTOMER WAS UNABLE TO CLEAR THE ALARMS AND REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 256 MG/DL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10556864 ↗
• InjurySep 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM (ER) DUE TO BLOOD GLUCOSE (BG) LEVEL OF 29 MG/DL, AND A SEIZURE. CAUSE OF BG LEVEL WAS UNKNOWN, HOWEVER CUSTOMER WAS CERTAIN THE PUMP OR RELATED SUPPLIES WERE NOT THE CAUSE. BG WAS TREATED WITH INTRAVENOUS GLUCOSE. REPORTEDLY, CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN DELIVERY.

  Patient problems: Hypoglycemia; Seizures

  MAUDE report 10510906 ↗
• MalfunctionSep 3, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. CUSTOMER¿S BLOOD GLUCOSE WAS 213 MG/DL. REPORTEDLY, THE CUSTOMER RELOADED THE SAME CARTRIDGE AND CONTINUED INSULIN THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10488704 ↗
• InjurySep 2, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER'S BLOOD GLUCOSE WAS IN 700 MG/DL RANGE. ELEVATED BLOOD GLUCOSE WAS ADDRESS WITH MANUAL INJECTION AND CORRECTION BOLUS VIA THE PUMP. CUSTOMER CHANGED PUMP SUPPLIES AND RESUMING INSULIN TO ADDRESS THE ISSUE.

  Patient problems: Hyperglycemia

  MAUDE report 10485360 ↗
• MalfunctionAug 28, 2020Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 200 MG/DL. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10464859 ↗
• MalfunctionAug 7, 2020Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A POWER SOURCE ALERT. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE CUSTOMER WAS ABLE TO SUCCESSFULLY CHARGE THE PUMP USING A DIFFERENT CABLE. CUSTOMER¿S BLOOD GLUCOSE VALUE WAS 210 MG/DL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10381327 ↗
• MalfunctionJul 29, 2020Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT AN UNEXPECTED RESET OCCURRED. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED BETWEEN 80-200 MG/DL. REPORTEDLY, THE CUSTOMER HAD MANUAL INJECTIONS AS ALTERNATE INSULIN THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10338164 ↗
• MalfunctionJul 22, 2020Battery Problem; Data Problem; Battery Problem; Data Problem

  IT WAS REPORTED THAT THE BATTERY WAS DEPLETING QUICKLY. ADDITIONALLY, THE PUMP DID NOT RECORD BOLUS HISTORY CORRECTLY. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE. REPORTEDLY THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10307299 ↗
• MalfunctionJul 17, 2020Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT MULTIPLE INTERMITTENT CARTRIDGE ALARMS (ALARM 01) OCCURRED WITH MULTIPLE CARTRIDGES DURING BASAL DELIVERIES. A NEW CARTRIDGE WAS SUCCESSFULLY LOADED TO ADDRESS THE EVENT. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 140 MG/DL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10289128 ↗
• MalfunctionJul 15, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT INTERMITTENTLY, THE PUMP DID NOT DELIVER BASAL INSULIN AS INTENDED. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. TANDEM TECHNICAL SUPPORT REVIEWED PUMP DATA LOGS AND FOUND THAT THE CUSTOMER LOADED A TOTAL OF FOUR CARTRIDGES WHILE USING THE PUMP OVER A PERIOD OF FOUR MONTHS. REPORTEDLY, THE CUSTOMER DECLINED ADDITIONAL TROUBLESHOOTING AND REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10275333 ↗