t:slim X2 Insulin Pump with Control-IQ 1005013Recalls & reported problems

Summary

The FDA's MAUDE database contains 5,097 adverse event reports that list this exact device (DI 00850006613212), received between Feb 13, 2020 and Dec 4, 2025 — classified as 442 injuries, 4,655 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (967 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 5,097 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Failure to Charge; Pumping Stopped; Failure to Charge; Pumping Stopped

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A POWER SOURCE ALERT AFTER PLUGGING THE PUMP INTO A WALL OUTLET, CAUSING THE PUMP TO SHUT DOWN. 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 23716354 ↗
• MalfunctionOct 15, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. 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 23291957 ↗
• InjuryAug 18, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. REPORTEDLY, THE CUSTOMER HAD BEEN USING THE SAME CARTRIDGE AND INFUSION SET FOR OVER 2 DAYS USING HUMALOG INSULIN. TANDEM CUSTOMER TECHNICAL SUPPORT INFORMED CUSTOMER THAT HUMALOG INSULIN IS INDICATED FOR USE WITH TANDEM SUPPLIES FOR 2 DAYS. CUSTOMER CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUE. THE CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS DISPLAYED AS ¿HIGH¿; HOWEVER, A SPECIFIC VALUE WAS NOT PROVIDED. CUSTOMER ADMINISTERED A MANUAL INJECTION TO ADDRESS THEIR BG LEVEL.

  Patient problems: Hyperglycemia

  MAUDE report 22829334 ↗
• MalfunctionAug 8, 2025Date/Time-Related Software Problem; Date/Time-Related Software Problem

  IT WAS REPORTED THAT THE PUMP DATE WAS INCORRECT, CAUSE WAS UNKNOWN. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. 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 22750361 ↗
• InjuryAug 8, 2025Date/Time-Related Software Problem; Date/Time-Related Software Problem

  IT WAS REPORTED THAT THE PUMP TIME WAS INCORRECT, CAUSE WAS UNKNOWN. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS "HIGH", ALTHOUGH A SPECIFIC VALUE WAS NOT GIVEN. THE CUSTOMER ADMINISTERED A MANUAL INJECTIONS TO ADDRESS THEIR BG. TIME ISSUE ALSO CAUSED THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL TO BE "LOW", ALTHOUGH A SPECIFIC VALUE WAS NOT GIVEN. THE CUSTOMER CONSUMED CARBOHYDRATES. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE CUSTOMER CORRECTED THE TIME AND RESUMED INSULIN THERAPY.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 22750349 ↗
• InjuryAug 7, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE WAKE BUTTON WAS STICKING. THE CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS DISPLAYED AS ¿LOW¿; HOWEVER, A SPECIFIC VALUE WAS NOT PROVIDED. CUSTOMER SUSPENDED PUMP USE TO ADDRESS BG LEVEL. REPLACEMENT PUMP WAS SENT TO CUSTOMER TO RESOLVE THE ISSUE.

  Patient problems: Hypoglycemia

  MAUDE report 22738235 ↗
• MalfunctionJul 25, 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 22610393 ↗
• MalfunctionJul 22, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS 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 22571714 ↗
• MalfunctionJul 8, 2025Break; Break

  A CARTRIDGE CHANGE ERROR WAS REPORTED FOR THE PUMP, AND THE O-RING IN THE CARTRIDGE WAS FOUND TO BE OUT OF PLACE AND DAMAGED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT WORKED WITH THE CUSTOMER TO TROUBLESHOOT THE ISSUE, INCLUDING INSPECTING AND CLEANING THE PUMP'S PNEUMATIC TAP AREA, ATTACHING THE CARTRIDGE CORRECTLY, AND CONFIRMING IT WAS FULLY SNAPPED INTO PLACE. DESPITE THESE EFFORTS, THE CUSTOMER WAS UNABLE TO SUCCESSFULLY LOAD THE CARTRIDGE ONTO THE CURRENT PUMP, BUT THEY WERE ABLE TO DO SO ON A NEW PUMP. THE CUSTOMER RECEIVED CARTRIDGE REPLACEMENTS, AND THE ISSUE WAS RESOLVED WITH INSULIN DELIVERY RESUMED, REQUIRING NO FURTHER ACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437555 ↗
• MalfunctionJul 1, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE. THERE WAS NO ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22379532 ↗
• MalfunctionJul 1, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE. MULTIPLE CONTACT ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE ISSUE; HOWEVER, THE CUSTOMER DID NOT RESPOND. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22379438 ↗
• MalfunctionMay 29, 2025Charging 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 22106886 ↗
• MalfunctionMar 31, 2025Battery Problem; Battery Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734892 ↗
• MalfunctionMar 18, 2025Pumping Stopped; Pumping Stopped

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633416 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A BLOOD GLUCOSE (BG) LEVEL THAT WAS DISPLAYED AS ¿HIGH¿; HOWEVER, A SPECIFIC VALUE WAS NOT PROVIDED. REPORTEDLY, THE CUSTOMER ALLEGED THE PUMP SOFTWARE DID NOT ACCURATELY ADJUST THE AMOUNT OF INSULIN DELIVERED RESULTING IN THE HIGH BG. CUSTOMER GAVE A MANUAL INJECTION TO ADDRESS BG LEVEL. TANDEM TECHNICAL SUPPORT (CTS) PERFORMED A SYSTEM CHECK AND PERFORMED A REVIEW OF THE PUMP DATA TO DETERMINE A POSSIBLE CAUSE. CTS DETERMINED THAT THE PUMP FUNCTIONED AS INTENDED AND THE CAUSE OF THE HIGH BG WAS UNKNOWN, CUSTOMER ACKNOWLEDGED AND UNDERSTOOD. RECOMMENDATION WAS MADE TO DISCUSS DIABETES MANAGEMENT WITH A HEALTH CARE PROFESSIONAL.

  Patient problems: Hyperglycemia

  MAUDE report 21504926 ↗
• InjuryFeb 25, 2025Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. DURING TROUBLESHOOTING WITH TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED, AND INSULIN DELIVERY WAS RESUMED SUCCESSFULLY. THE CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS DISPLAYED AS ¿HIGH¿; HOWEVER, A SPECIFIC VALUE WAS NOT PROVIDED. BG LEVEL WAS CORRECTED WITH A BOLUS VIA THE PUMP.

  Patient problems: Hyperglycemia

  MAUDE report 21459734 ↗
• MalfunctionFeb 13, 2025Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS 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 21371218 ↗
• MalfunctionFeb 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CARTRIDGE O-RING WAS MISSING. THE CUSTOMER CONFIRMED THE O-RING WAS NOT LOCATED ON THE PNEUMATIC TAP. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. A NEW CARTRIDGE WAS LOADED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21367509 ↗
• MalfunctionJan 3, 2025Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT THE PUMP TOUCH SCREEN IS SCRATCHED, LEADING TO SCREEN BEING 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 21066761 ↗
• MalfunctionJan 2, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE WAKE BUTTON WAS NOT WORKING. 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 21055150 ↗
• MalfunctionDec 9, 2024Device 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. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20881134 ↗
• MalfunctionDec 6, 2024Failure to Sense; Date/Time-Related Software Problem; Failure to Sense; Date/Time-Related Software Problem

  IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS INTERMITTENTLY UNRESPONSIVE. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP TIME WAS INCORRECT, CAUSE WAS UNKNOWN. 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 20872999 ↗
• MalfunctionDec 6, 2024Failure to Sense; Battery Problem; Failure to Sense; Battery Problem

  IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE AND 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 20863669 ↗
• MalfunctionNov 25, 2024Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO CHARGE THE PUMP USING THE TANDEM-PROVIDED USB CHARGING CABLE AND 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 USB CABLE AND WALL POWER ADAPTER. THE CUSTOMER WAS SENT NEW CHARGING SUPPLIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20772761 ↗
• MalfunctionNov 15, 2024Incorrect Measurement; Fitting Problem; Battery Problem; Incorrect Measurement; Fitting Problem; Battery Problem

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY, A CARTRIDGE DID NOT FIT ONTO THE PUMP AND THE INSULIN GAUGE WAS INACCURATE. 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 20694147 ↗