t:slim X2 Insulin Pump with Control-IQ 1005011Recalls & reported problems

Summary

The FDA's MAUDE database contains 35,600 adverse event reports that list this exact device (DI 00850006613205), received between Jan 23, 2020 and Sep 28, 2026 — classified as 3 deaths, 3,220 injuries, 32,377 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (7,570 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 35,600 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917126 ↗
• MalfunctionJul 8, 2026Failure to Charge

  IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. 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 25753214 ↗
• MalfunctionJul 7, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. 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 25742747 ↗
• MalfunctionJun 26, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. 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 25641397 ↗
• MalfunctionJun 24, 2026Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE CUSTOMER WOULD RECEIVED "BUTTON ERRORS" ON THE PUMP, REQUIRING A PUMP RESET IN ORDER TO FUNCTION AGAIN. NO INFORMATION IF CUSTOMER WAS REFERRING TO THE WAKE BUTTON ON THE PUMP OR THE BUTTONS ON THE PUMP TOUCHSCREEN. 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 25611979 ↗
• MalfunctionJun 17, 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 25538168 ↗
• MalfunctionJun 17, 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 25534814 ↗
• MalfunctionJun 15, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A CONTINUOUS GLUCOSE MONITOR ERROR 42. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER. THE CUSTOMER WAS INSTRUCTED TO RESET THE PUMP TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25511760 ↗
• MalfunctionJun 15, 2026False Alarm

  IT WAS REPORTED THAT AN ALTITUDE ALARM OCCURRED. REPORTEDLY, THE PUMP WAS NOT OUTSIDE THE LABELED ALTITUDE OPERATING RANGE. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CARTRIDGE WAS RELOADED, AND INSULIN DELIVERY WAS RESUMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25508835 ↗
• MalfunctionJun 15, 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 DID NOT HAVE AN ALTERNATE METHOD OF INSULIN THERAPY AVAILABLE. REPORTEDLY, THE CUSTOMER WOULD REACH OUT TO THEIR HCP TO OBTAIN A BACKUP METHOD OF INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25505211 ↗
• MalfunctionJun 10, 2026False Alarm

  IT WAS REPORTED THAT AN ALTITUDE ALARM OCCURRED. REPORTEDLY, THE PUMP WAS NOT OUTSIDE THE LABELED ALTITUDE OPERATING RANGE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE. REPORTEDLY A NEW CARTRIDGE WAS LOADED, AND INSULIN DELIVERY WAS RESUMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25464795 ↗
• MalfunctionJun 9, 2026Air/Gas in Device

  IT WAS REPORTED THAT AIR BUBBLES WERE OBSERVED WITHIN THE CARTRIDGE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER PERFORMED A SUPPLY CHANGE TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25446240 ↗
• MalfunctionMay 28, 2026Break; Charging Problem

  IT WAS REPORTED THAT CWAS REPORTED THAT THE USB PORT WAS DAMAGED AS THE TANDEM CHARGING CABLE BECAME STUCK INSIDE THE USB PORT AND AS A RESULT THE CUSTOMER WAS UNABLE TO CHARGE THE PUMP AND THE PUMP SUBSEQUENTLY SHUTDOWN. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25314655 ↗
• MalfunctionMay 27, 2026Break; Melted

  IT WAS REPORTED THAT PUMP HOUSING HAD PLASTIC MELTING AROUND CARTRIDGE AREA AND THERE WAS A "CRACK ON PUMP". THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING ACTIONS TAKEN BY CUSTOMER OR TECHNICAL SUPPORT IN RESPONSE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25306872 ↗
• MalfunctionMay 20, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS BLURRY. THERE WAS NO ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25236792 ↗
• InjuryMay 15, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM WITH AN UNKNOWN LOW BLOOD GLUCOSE LEVEL. THE CUSTOMER ALLEGED THAT THE PUMP DID NOT ACCURATELY ADJUST THE AMOUNT OF INSULIN DELIVERED. CUSTOMER DECLINED TO TROUBLESHOOT THE ISSUE WITH TANDEM TECHNICAL SUPPORT; THEREFORE NO ADDITIONAL INFORMATION WAS OBTAINED.

  Patient problems: Hypoglycemia

  MAUDE report 25182982 ↗
• MalfunctionMay 12, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT SPIDERWEB CRACKS WERE OBSERVED BEHIND THE TOUCHSCREEN. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE VALUE. REPORTEDLY, THE CUSTOMER CONTACTED THE HEALTHCARE PROVIDER TO OBTAIN ALTERNATE INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150196 ↗
• MalfunctionMay 4, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT PUMP WOULD NOT TURN ON AND CALLER STATED ISSUE HAD ALREADY BEEN REPORTED. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CALLER DECLINED TROUBLESHOOTING, STATED THAT PROCESS FOR REPLACEMENT PUMP THROUGH CCS MEDICAL HAD ALREADY BEGUN, AND NO FURTHER ACTION WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068897 ↗
• MalfunctionMay 1, 2026Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE WAKE BUTTON ON THE PUMP HAD TO BE PRESSED MULTIPLE TIMES IN ORDER TO TURN THE PUMP SCREEN ON. 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 25059014 ↗
• MalfunctionApr 28, 2026Fracture

  IT WAS REPORTED THAT THE PUMP TOUCHSCREEN WAS CRACKED AND UNRESPONSIVE AND UNREADABLE. THERE WAS NO 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 25017553 ↗
• MalfunctionApr 21, 2026Pumping Stopped

  IT WAS REPORTED THAT PUMP EXPERIENCED MALFUNCTION ALARM WITH CODE DISPLAYED AND NO NOTABLE EVENTS OCCURRED BEFOREHAND. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER CONTACTED TECHNICAL SUPPORT, RECEIVED INSTRUCTIONS TO RESET PUMP, SUCCESSFULLY CLEARED MALFUNCTION WITHOUT RECURRENCE, WAS ADVISED TO CONTINUE USING PUMP, AND WAS INSTRUCTED TO CALL BACK IF MALFUNCTION RETURNED, WHICH CUSTOMER ACKNOWLEDGED AND UNDERSTOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941857 ↗
• MalfunctionApr 20, 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 24927990 ↗
• MalfunctionApr 16, 2026Pumping 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 REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24904346 ↗
• MalfunctionApr 16, 2026Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE WAKE BUTTON WAS NOT WORKING. CUSTOMER PRESSED THE WAKE BUTTON MULTIPLE TIMES AND THE WAKE BUTTON PERFORMED AS INTENDED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899728 ↗
• MalfunctionApr 11, 2026Failure to Charge

  IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER. 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 24845899 ↗