t:slim X2 Insulin Pump with Control-IQ 1005012Recalls & reported problems

Summary

The FDA's MAUDE database contains 4,129 adverse event reports that list this exact device (DI 00850006613229), received between Jan 30, 2020 and May 5, 2026 — classified as 593 injuries, 3,536 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (642 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 18, 2026.

Recalls naming this device

1. May 24, 2022Class IIOpen, 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 4,129 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PUMP BATTERY "DEPLETES RAPIDLY". THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER. THE CUSTOMER DECLINED ASSISTANCE FROM TANDEM TECHNICAL SUPPORT REGARDING THE ISSUE. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25088351 ↗
• MalfunctionApr 21, 2026Overheating of Device

  IT WAS REPORTED THAT THE PUMP WAS WARM TO THE TOUCH DESPITE BEING IN ROOM-TEMPERATURE CONDITIONS. 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 24941361 ↗
• InjuryApr 21, 2026Use of Incorrect Control/Treatment Settings

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A BLOOD GLUCOSE (BG) LEVEL WAS DISPLAYED AS ¿HIGH¿; HOWEVER, A SPECIFIC VALUE WAS NOT PROVIDED, AND A LOW BG LEVEL OF 39 MG/DL. SUSPECTED CAUSE WAS DUE TO THE CUSTOMER¿S SETTINGS REQUIRING ADJUSTMENTS. REPORTEDLY, THE CUSTOMER ADMINISTERED A MANUAL INJECTION TO ADDRESS ELEVATED BG LEVEL AND CONSUMED CARBOHYDRATES TO ADDRESS LOW BG. CUSTOMER UPDATED THEIR PUMP SETTINGS TO ADDRESS THE EVENT.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 24940402 ↗
• MalfunctionMar 26, 2026Charging Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A POWER SOURCE ALERT WHILE USING THE TANDEM-PROVIDED USB CABLE AND TANDEM-PROVIDED WALL CHARGING ADAPTER. REPORTEDLY, THE CUSTOMER WAS ABLE TO SUCCESSFULLY CHARGE THE PUMP USING AN ALTERNATE WALL ADAPTER AND USB CABLE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE VALUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699242 ↗
• MalfunctionMar 10, 2026Pumping Stopped

  CALLER REPORTED A MALFUNCTION ON THE PUMP WITH NO NOTABLE EVENTS OCCURRING BEFOREHAND. IT WAS UNKNOWN WHETHER THERE WAS ANY ADVERSE IMPACT ON THE CUSTOMER'S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT PROVIDED ASSISTANCE WITH RESETTING THE PUMP AND INSTRUCTED THE CALLER TO REACH OUT AGAIN IF THE MALFUNCTION RECURRED. THE CUSTOMER ACKNOWLEDGED AND UNDERSTOOD THE INSTRUCTIONS AND WAS ABLE TO CONTINUE USING THE PUMP WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561602 ↗
• MalfunctionJan 26, 2026Charging Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A POWER SOURCE ALERT WHILE USING THE TANDEM-PROVIDED USB CABLE AND WALL ADAPTER. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE CUSTOMER WAS ABLE TO SUCCESSFULLY CHARGE THE PUMP USING AN ALTERNATE WALL ADAPTER AND USB CABLE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178719 ↗
• MalfunctionJan 16, 2026Incorrect Measurement

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24096367 ↗
• MalfunctionNov 4, 2025Failure to Charge; Pumping Stopped; Failure to Charge; Pumping Stopped

  IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED WHICH RESULTED IN THE PUMP SHUTTING DOWN. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23463757 ↗
• MalfunctionOct 30, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. 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 23433167 ↗
• MalfunctionOct 29, 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 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 23421014 ↗
• MalfunctionOct 29, 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. 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 23416444 ↗
• MalfunctionSep 19, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. 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 23098194 ↗
• MalfunctionSep 17, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PUMP HAS INCONSISTENT BATTERY LIFE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED TROUBLESHOOTING AND IS IN THE PROCESS OF OBTAINING A NEW DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23076692 ↗
• MalfunctionSep 17, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. CUSTOMER LOADED A NEW CARTRIDGE TO RESOLVE THE ISSUE. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23071659 ↗
• MalfunctionSep 15, 2025Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT A CARTRIDGE DID NOT FIT ONTO THE PUMP. A CARTRIDGE CHANGE WAS PERFORMED RESOLVING THE ISSUE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS "HIGH", SPECIFIC VALUE WAS NOT PROVIDED. CUSTOMER ADMINISTERED A CORRECTION BOLUS VIA THE PUMP.

  Patient problems: Hyperglycemia

  MAUDE report 23057856 ↗
• MalfunctionSep 15, 2025Date/Time-Related Software Problem; Date/Time-Related Software Problem

  A CALLER REPORTED AN ISSUE WITH THE INCORRECT TIME SETTING ON THEIR DEVICE, WHICH RESULTED IN CONFUSION. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL AS NO EXTREME LEVELS WERE REPORTED. TECHNICAL SUPPORT ASSISTED THE CALLER IN UPDATING THE PUMP TIME AND ADVISED THEM TO MONITOR THE TIME SETTINGS FOR ANY FUTURE DISCREPANCIES, INSTRUCTING THEM TO FOLLOW UP IF THE ISSUE RECURRED. THE CALLER UNDERSTOOD AND ACKNOWLEDGED THE GUIDANCE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052628 ↗
• MalfunctionSep 3, 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 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 22954801 ↗
• MalfunctionSep 2, 2025Date/Time-Related Software Problem; Date/Time-Related Software Problem

  IT WAS REPORTED THAT THE PUMP TIME WAS INCORRECT, CAUSE WAS UNKNOWN. THERE WAS NO 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 22938856 ↗
• MalfunctionSep 2, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO CHARGE THE PUMP USING THE TANDEM-PROVIDED CHARGING SUPPLIES. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER WAS ABLE TO SUCCESSFULLY CHARGE THE PUMP USING SECONDARY CHARGING SUPPLIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22937073 ↗
• MalfunctionSep 2, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE WAKE BUTTON ON THE PUMP WAS DIFFICULT TO PRESS AND UNRESPONSIVE AT TIMES. THERE WAS NO 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 22937024 ↗
• MalfunctionAug 27, 2025Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING INSULIN DELIVERY. CUSTOMER REVERTED TO AN ALTERNATE METHOD OF 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 22905778 ↗
• MalfunctionAug 26, 2025Failure to Charge; Pumping Stopped; Failure to Charge; Pumping Stopped

  IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED, RESULTING IN THE PUMP SHUTTING DOWN. IT WAS NOTED THAT THE CUSTOMER WAS USING NON-TANDEM PROVIDED CHARGING SUPPLIES TO CHARGE THE PUMP. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE. REPORTEDLY, THE PUMP SUCCESSFULLY BEGAN CHARGING AFTER LEAVING THE PUMP PLUGGED INTO THE POWER SOURCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22898682 ↗
• MalfunctionAug 25, 2025Loose or Intermittent Connection; Charging Problem; Loose or Intermittent Connection; Charging Problem

  IT WAS REPORTED THAT THE PUMP'S 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. THERE WAS NO 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 22883962 ↗
• MalfunctionAug 22, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE WAKE BUTTON BECAME DETACHED FROM THE PUMP. 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 22871295 ↗
• MalfunctionAug 20, 2025Failure to Charge; Failure to Charge

  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 22854668 ↗