t:slim X2 Pump, Replacement, Refurb. 1000353Recalls & reported problems

Summary

The FDA's MAUDE database contains 320 adverse event reports that list this exact device (DI 00853052007240), received between Jul 9, 2018 and Dec 10, 2024 — classified as 22 injuries, 298 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (72 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 24, 2022Open, 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

Recent adverse event reports

The 25 most recent of 320 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2024Incorrect Measurement; Pumping Stopped; Battery Problem; Incorrect Measurement; Pumping Stopped; Battery Problem

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. ADDITIONALLY, THE BATTERY GAUGE WAS FLUCTUATING RESULTING IN THE PUMP SHUTTING DOWN. 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 20895202 ↗
• MalfunctionJul 2, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A CONTINUOUS GLUCOSE MONITOR ERROR 42. REPORTEDLY, CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660909 ↗
• MalfunctionMar 25, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A CONTINUOUS GLUCOSE MONITOR ERROR 42. THERE WAS NO PATIENT INVOLVEMENT, AS THE PUMP WAS BEING USED FOR DEMONSTRATION AND WAS NOT BEING USED ON A CUSTOMER AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18969775 ↗
• MalfunctionJan 12, 2024Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. THERE WAS NO IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE. REPORTEDLY THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18505571 ↗
• MalfunctionOct 2, 2023Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT AN UNSPECIFIED MALFUNCTION ALARM OCCURRED. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 125 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17852473 ↗
• MalfunctionSep 21, 2023Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED, AND INSULIN DELIVERY WAS RESUMED SUCCESSFULLY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 100MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17794941 ↗
• MalfunctionSep 20, 2023Date/Time-Related Software Problem; Communication or Transmission Problem; Date/Time-Related Software Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A CONTINUOUS GLUCOSE MONITOR ERROR 42. THE PUMP WAS RESET TO RESOLVE THE ISSUE. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP TIME WAS INCORRECT, CAUSE WAS UNKNOWN. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE CUSTOMER CORRECTED THE TIME AND RESUMED INSULIN THERAPY. THERE WAS NO REPORTED ADVERSE IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17782694 ↗
• MalfunctionSep 15, 2023Incorrect Measurement; Obstruction of Flow; Battery Problem; Incorrect Measurement; Obstruction of Flow; Battery Problem

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY, THAT THE BATTERY GAUGE WAS FLUCTUATING AND THAT AN OCCLUSION ALARM OCCURRED. 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 17757923 ↗
• MalfunctionSep 13, 2023Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT AN UNSPECIFIED MALFUNCTION ALARM OCCURRED. THERE WAS NO ADVERSE IMPACT TO 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 17736923 ↗
• MalfunctionAug 16, 2023Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE PUMP BATTERY WAS UNRESPONSIVE. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 184 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17559711 ↗
• MalfunctionJun 21, 2023Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A POWER SOURCE ALERT AFTER PLUGGING THE PUMP INTO A WALL OUTLET. CUSTOMER¿S BLOOD GLUCOSE VALUE WAS 148-158 MG/DL. 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 17170638 ↗
• MalfunctionJun 14, 2023Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED, AND INSULIN DELIVERY WAS RESUMED SUCCESSFULLY. THERE WAS NO ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17127797 ↗
• MalfunctionMay 15, 2023Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE WAKE BUTTON WAS STICKING. 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 16930897 ↗
• MalfunctionApr 25, 2023Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 150 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16807167 ↗
• MalfunctionMar 24, 2023Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE PUMP BATTERY WAS UNRESPONSIVE. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 189 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16610948 ↗
• MalfunctionDec 13, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUE AND RESUMED INSULIN DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE RANGED FROM 230 TO 300 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15969063 ↗
• MalfunctionNov 21, 2022Filling Problem; Incorrect Measurement; Pumping Stopped; Filling Problem; Incorrect Measurement; Pumping Stopped

  IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. ADDITIONALLY, IT WAS REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 130 UNITS OF INSULIN DURING THE LOAD SEQUENCE. A NEW CARTRIDGE WAS LOADED TO RESOLVE THE ISSUE. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED, AND INSULIN DELIVERY WAS RESUMED SUCCESSFULLY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 130 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15834122 ↗
• MalfunctionNov 4, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED FOLLOW UP FROM TANDEM TECHNICAL SUPPORT, THEREFORE NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15727377 ↗
• MalfunctionNov 2, 2022Loose or Intermittent Connection; Fitting Problem; Battery Problem; Loose or Intermittent Connection; Fitting Problem; Battery Problem

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP USB PORT WAS LOOSE, AND THE PUMP BATTERY INTERMITTENTLY COULD NOT BE CHARGED PROPERLY WITHOUT THE CUSTOMER MANEUVERING THE CABLE INTO THE CHARGING PORT AT A CERTAIN ANGLE. IT WAS ALSO REPORTED THAT A CARTRIDGE DID NOT FIT ONTO 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 15716510 ↗
• MalfunctionSep 7, 2022Incorrect 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 15371938 ↗
• MalfunctionAug 19, 2022Data Problem; Data Problem

  IT WAS REPORTED THAT THE PUMP INDICATED A DATA LOG CORRUPTION. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 130 MG/DL. REPORTEDLY, CUSTOMER CONTINUED USING PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15258917 ↗
• MalfunctionAug 2, 2022Failure to Sense; Battery Problem; 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 INTERMITTENTLY UNRESPONSIVE. CUSTOMER DECLINED TROUBLESHOOTING 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 15148367 ↗
• MalfunctionJul 20, 2022Failure to Sense; Battery Problem; 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 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 15068997 ↗
• MalfunctionJul 11, 2022Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. REPORTEDLY THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 90 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14977523 ↗
• MalfunctionJun 21, 2022Incorrect Measurement; Failure to Sense; Battery Problem; Incorrect Measurement; Failure to Sense; Battery Problem

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. ADDITIONALLY, IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE AND THAT THE TOUCHSCREEN WAS UNRESPONSIVE. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED FOLLOW UP FROM TANDEM TECHNICAL SUPPORT, THEREFORE FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14761666 ↗