t:slim X2 Insulin Pump with Basal-IQ 1000898Recalls & reported problems

Summary

The FDA's MAUDE database contains 16,106 adverse event reports that list this exact device (DI 00853052007301), received between Jan 18, 2019 and Sep 28, 2026 — classified as 6 deaths, 2,274 injuries, 13,826 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (2,206 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 16,106 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Failure to Charge; Pumping Stopped

  It was reported that the customer received a power source alert after plugging the pump into a wall outlet, resulting in the pump shutting down. 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 50916196 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the customer experienced an elevated blood glucose (BG) level of 508 mg/dL; cause unknown. Customer administered a correction injection to address the BG. Recommendation was made to consult a healthcare provider in regards to diabetes management.

  Patient problems: Hyperglycemia

  MAUDE report 50158976 ↗
• MalfunctionJul 9, 2026Pumping Stopped

  IT WAS REPORTED THAT CARTRIDGE ALARM 20 OCCURRED AND THAT CALLER HAD EXPERIENCED CARTRIDGE ALARMS WITH CONSECUTIVE CARTRIDGES, ALTHOUGH ISSUE DID NOT OCCUR DURING LOAD PROCESS. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER PLANNED TO USE BACKUP INSULIN THERAPY, AND TECHNICAL SUPPORT ARRANGED FOR PUMP REPLACEMENT EVEN THOUGH PUMP WAS OUT OF WARRANTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25763154 ↗
• MalfunctionJul 9, 2026Image Display Error/Artifact

  IT WAS REPORTED THAT PUMP SCREEN WAS PIXELATED AND SCRATCHED, WHICH MADE PUMP DISPLAY DIFFICULT TO READ. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED FURTHER TROUBLESHOOTING, AND NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING ANY FURTHER ACTIONS TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25761916 ↗
• MalfunctionJul 8, 2026Incorrect Measurement

  IT WAS REPORTED THAT INSULIN GAUGE DISPLAYED AMOUNT DIFFERENT THAN EXPECTED ON A PREVIOUS DAY, WITH PUMP SHOWING ABOUT 60 UNITS WHEN CALLER EXPECTED 100 TO 108 UNITS AND DIFFERENCE WAS GREATER THAN 30 UNITS, BUT PUMP WAS NOT DISPLAYING AN UNEXPECTED AMOUNT AT TIME OF CALL. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER RESOLVED ISSUE BY RELOADING SAME CARTRIDGE, DECLINED EMAIL RESOURCES, AND WAS INSTRUCTED BY TECHNICAL SUPPORT TO CALL BACK FOR TROUBLESHOOTING IF A SIMILAR ACTIVE FILL ESTIMATE ISSUE OCCURRED AGAIN, WHICH CALLER ACKNOWLEDGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25753479 ↗
• MalfunctionJul 8, 2026Incorrect Measurement

  IT WAS REPORTED THAT PUMP INSULIN GAUGE DISPLAYED AN AMOUNT DIFFERENT THAN WHAT CALLER EXPECTED ON A PREVIOUS DAY, WITH PUMP SHOWING NO INSULIN IN CARTRIDGE WHILE CALLER EXPECTED AROUND 100 TO 108 UNITS AND DIFFERENCE WAS GREATER THAN 30 UNITS. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER RESOLVED ISSUE BY RELOADING SAME CARTRIDGE, DECLINED EMAIL RESOURCES, AND WAS INSTRUCTED BY TECHNICAL SUPPORT TO CALL BACK FOR TROUBLESHOOTING IF ACTIVE FILL ESTIMATE ISSUE OCCURRED AGAIN, WHICH CALLER ACKNOWLEDGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25753456 ↗
• MalfunctionJul 8, 2026Display or Visual Feedback Problem; Scratched Material

  IT WAS REPORTED THAT PUMP SCREEN WAS PIXELATED MAKING PUMP DISPLAY DIFFICULT TO READ. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED FURTHER TROUBLESHOOTING, AND NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING FURTHER ACTIONS OR OUTCOME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25746650 ↗
• MalfunctionJul 7, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT BATTERY DEPLETED TOO QUICKLY. 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 25738255 ↗
• MalfunctionJul 6, 2026Break

  IT WAS REPORTED THAT CARTRIDGE DID NOT FIT IN FLUSH AND PUMP CASING WAS CRACKED ON OUT-OF-WARRANTY T:SLIM X2 PUMP. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER CONTACTED TANDEM BY PHONE TO REPORT ISSUE, AND COMPLAINT WAS DOCUMENTED FOR REVIEW, BUT NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING FURTHER ACTIONS OR OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25717332 ↗
• MalfunctionJul 2, 2026Display or Visual Feedback Problem; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT PUMP SCREEN WAS DAMAGED AND 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 25692887 ↗
• MalfunctionJun 26, 2026Failure to Charge

  IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. 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 25641166 ↗
• MalfunctionJun 18, 2026Obstruction of Flow

  IT WAS REPORTED THE PUMP WAS DISPLAYING CONSTANT OCCLUSION ALARMS. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE 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 25548010 ↗
• MalfunctionJun 15, 2026Date/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. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE CUSTOMER CORRECTED THE TIME AND RESUMED INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25505733 ↗
• InjuryJun 4, 2026Obstruction of Flow

  IT WAS REPORTED THAT ONGOING INTERMITTENT OCCLUSION ALARMS OCCURRED. REPORTEDLY, THE CUSTOMER FAILED TO COMPLETE THE AIR REMOVAL STEP FOR CARTRIDGE. TANDEM CUSTOMER TECHNICAL SUPPORT EDUCATED CUSTOMER TO FOLLOW THE PROPER AIR REMOVAL STEPS. CUSTOMER CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS DISPLAYED AS "HIGH"; HOWEVER, SPECIFIC VALUE WAS NOT PROVIDED. ELEVATED BG WAS ADDRESSED BY A MANUAL INSULIN INJECTION.

  Patient problems: Hyperglycemia

  MAUDE report 25399576 ↗
• MalfunctionMay 29, 2026Unexpected Shutdown

  IT WAS REPORTED THAT THE PUMP SHUT OFF UNEXPECTEDLY. 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 25337270 ↗
• MalfunctionMay 21, 2026Priming Problem

  IT WAS REPORTED THAT INSULIN DRIPS WERE NOT OBSERVED TO BE EXITING THE INFUSION SET TUBING DURING THE LOAD FILL PROCESS. REPORTEDLY, A SUPPLY CHANGE WAS PERFORMED TO ADDRESS THE ISSUE AND INSULIN DELIVERY WAS RESUMED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243661 ↗
• MalfunctionMay 12, 2026Break

  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 SUCCESSFULLY LOADED THE CARTRIDGE TO ADDRESS THE EVENT. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE VALUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150887 ↗
• MalfunctionMay 11, 2026Scratched Material

  IT WAS REPORTED THAT THE PUMP TOUCHSCREEN WAS SCRATCHED, CAUSING IT TO BE DIFFICULT TO READ AND BE UNRESPONSIVE. 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 25143018 ↗
• MalfunctionMay 11, 2026Key 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 25141879 ↗
• MalfunctionMay 11, 2026Failure 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 25139351 ↗
• MalfunctionMay 8, 2026Fitting Problem

  IT WAS REPORTED THAT THE CARTRIDGES WERE NOT FITTING COMPLETELY FLUSH WITHIN THE PUMP. 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 25129269 ↗
• MalfunctionMay 5, 2026Pumping Stopped

  IT WAS REPORTED THAT THE PUMP EXPERIENCED A MALFUNCTION. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER REVERTED TO MULTIPLE DAILY INJECTIONS (MDI) FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25088654 ↗
• MalfunctionMay 5, 2026Failure to Charge

  IT WAS REPORTED THAT THE PUMP BATTERY INTERMITTENTLY COULD NOT BE CHARGED. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25081733 ↗
• MalfunctionApr 24, 2026Pumping Stopped

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24984876 ↗
• MalfunctionApr 22, 2026Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT AN UNEXPECTED RESET OCCURRED. THERE WAS NO REPORTED 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 24955246 ↗