t:slim X2 Insulin Pump with Basal-IQ 1000892Recalls & reported problems

Summary

The FDA's MAUDE database contains 5,216 adverse event reports that list this exact device (DI 00853052007288), received between Nov 9, 2018 and Jun 8, 2026 — classified as 1 death, 494 injuries, 4,721 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (858 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. How this data works · Data updated Oct 13, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 5,216 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT PUMP SCREEN WAS DARK AND WOULD NOT TURN ON DESPITE MULTIPLE ATTEMPTS TO WAKE IT. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25429495 ↗
• MalfunctionMay 11, 2026Pumping Stopped

  IT WAS REPORTED THAT PUMP MALFUNCTION OCCURRED WITHOUT ANY NOTABLE EVENTS BEFOREHAND. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS 438 MG/DL. CUSTOMER HAD NOT TAKEN ANY ACTION TO LOWER BLOOD GLUCOSE BEFORE CONTACTING SUPPORT, AND TECHNICAL SUPPORT ASSISTED CUSTOMER WITH RESETTING PUMP USING PROVIDED INSTRUCTIONS; MALFUNCTION DID NOT RECUR AFTER RESET, CUSTOMER WAS ADVISED TO CONTINUE USING PUMP AND TO CALL BACK IF MALFUNCTION OCCURRED AGAIN, AND CUSTOMER ACKNOWLEDGED AND UNDERSTOOD THESE INSTRUCTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136034 ↗
• MalfunctionDec 15, 2025Pumping Stopped; Pumping Stopped

  A MALFUNCTION ON THE PUMP WAS REPORTED BY THE CALLER, WITH NO NOTABLE EVENTS OCCURRING PRIOR TO THE INCIDENT. THERE WAS NO ADVERSE IMPACT ON THE CUSTOMER'S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT RESOLVED THE ISSUE BY REPLACING THE PUMP, AND THE CUSTOMER SWITCHED TO AN IN-WARRANTY PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804595 ↗
• MalfunctionNov 26, 2025Break; Charging Problem; Break; 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. 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 23658580 ↗
• MalfunctionNov 24, 2025Failure to Charge; Failure to Charge

  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 23640610 ↗
• MalfunctionNov 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  CALLER REPORTED A CGM ERROR IDENTIFIED AS ERROR 42. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT PROVIDED GUIDANCE FOR A COMPLETE PUMP RESET, ASSISTING THE CALLER THROUGH THE PROCESS, AND THE SENSOR SESSION WAS SUCCESSFULLY RESTARTED WITHOUT RECURRING ERROR MESSAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23453070 ↗
• MalfunctionOct 15, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE WAKE BUTTON WAS STICKING. 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 23299298 ↗
• MalfunctionSep 16, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING. THERE WAS NO REPORTED ADVERSE IMPACT. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066865 ↗
• MalfunctionSep 15, 2025Date/Time-Related Software Problem; Date/Time-Related Software Problem

  AN ISSUE WAS REPORTED INVOLVING AN INCORRECT TIME SETTING ON A PUMP, WHICH THE CALLER DID NOT UNDERSTAND THE CAUSE OF. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL AS PREVIOUS SETTINGS DID NOT RESULT IN ABNORMAL LEVELS. MULTIPLE ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO FOLLOW-UP WITH THE CUSTOMER ON THE REPORTED ISSUE, BUT NO RESPONSE WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051746 ↗
• MalfunctionJul 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  CUSTOMER REPORTED THAT PUMP WAS GIVING FALSE NO DELIVERY ALARMS AND NO PRIME ALARMS, WHICH RESULTED IN UNNECESSARY PRIMING AND INTERRUPTED INSULIN DELIVERY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER OPTED OUT OF TROUBLESHOOTING AND REQUESTED DOCUMENTATION FOR INSURANCE PURPOSES; NO FURTHER ACTION WAS TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22555542 ↗
• MalfunctionJul 17, 2025Failure to Charge; Failure to Charge

  CUSTOMER REPORTED THAT THE CURRENT PUMP DID NOT FULLY CHARGE THE BATTERY PROPERLY AND ISSUED A BATTERY ERROR WHILE CHARGING, PREVENTING THE PUMP FROM REACHING 100% CHARGE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED FURTHER ASSISTANCE FROM CTS, WAS CURRENTLY OUT OF WARRANTY, AND IN THE PROCESS OF ACQUIRING A NEW DEVICE. NO ADDITIONAL OUTCOME INFORMATION WAS RECEIVED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22534409 ↗
• MalfunctionJul 16, 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. THE CUSTOMER DECLINED FOLLOW UP WITH TANDEM TECHNICAL SUPPORT AND FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521616 ↗
• MalfunctionJul 16, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  A MALFUNCTION WAS REPORTED BY THE CUSTOMER, WHERE THE PUMP SCREEN WAS FROZEN AND UNRESPONSIVE TO INPUT. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER PERFORMED A PUMP RESET WITH GUIDANCE FROM TECHNICAL SUPPORT, AND THE ISSUE WAS RESOLVED, ALLOWING THE PUMP SCREEN TO FUNCTION NORMALLY AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521382 ↗
• MalfunctionJul 15, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING THE LOAD SEQUENCE. CUSTOMER LOADED SEVERAL NEW CARTRIDGES TO RESOLVE THE ISSUE HOWEVER THE CARTRIDGE ALARM RECURRED. 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 22507806 ↗
• MalfunctionMay 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CARTRIDGE DID NOT FIT ONTO THE PUMP. REPORTEDLY, THERE WAS AN O-RING FROM A PREVIOUS CARTRIDGE ON THE PNEUMATIC TAP. THE CUSTOMER REMOVED THE O-RING AND LOADED A NEW CARTRIDGE TO ADDRESS THE EVENT. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21979913 ↗
• MalfunctionMar 28, 2025Battery 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. 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 21721908 ↗
• MalfunctionMar 28, 2025Charging 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. REPORTEDLY, THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719477 ↗
• MalfunctionMar 26, 2025Pumping 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 21699297 ↗
• MalfunctionMar 19, 2025Filling Problem; Incorrect Measurement; Filling Problem; Incorrect Measurement

  IT WAS REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 225 UNITS OF INSULIN DURING THE LOAD SEQUENCE. REPORTEDLY, CUSTOMER DECLINED TO LOAD A NEW CARTRIDGE ON THE PUMP. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21646673 ↗
• MalfunctionFeb 24, 2025Battery 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 21446755 ↗
• MalfunctionJan 6, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE WAKE BUTTON WAS STICKING. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER PRESSED THE WAKE BUTTON MULTIPLE TIMES AND APPLIED MORE FORCE TO THE BUTTON TO RESOLVE THE ISSUE. THE CUSTOMER REVERTED TO ALTERNATE METHOD OF INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21084116 ↗
• MalfunctionDec 30, 2024Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE WAKE BUTTON WAS ¿OFTEN UNRESPONSIVE¿. 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 21035858 ↗
• MalfunctionDec 13, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING. THERE WAS NO REPORTED ADVERSE IMPACT TO CUSTOMER'S BLOOD GLUCOSE LEVEL. NO ADDITIONAL INFORMATION WAS PROVIDED. CUSTOMER DECLINED FOLLOW UP FROM TANDEM TECHNICAL SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20929399 ↗
• MalfunctionDec 12, 2024Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT THE P UMP TOUCHSCREEN WAS UNRESPONSIVE. THERE WAS NO ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL. DURING TROUBLESHOOTING WITH TECHNICAL SUPPORT, THE PUMP WAS RESET, AND THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20920993 ↗
• MalfunctionDec 10, 2024Difficult to Insert; Fitting Problem; Difficult to Insert; Fitting Problem

  IT WAS REPORTED THAT THE RACK PUSHROD ON THE PUMP WAS DAMAGED, WHICH LED TO DIFFICULTIES LOADING CARTRIDGES. REPORTEDLY, THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE VALUE WAS 266 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20898184 ↗