t:slim X2 Insulin Pump with Basal-IQ 1005706Recalls & reported problems

Summary

The FDA's MAUDE database contains 5,094 adverse event reports that list this exact device (DI 00850006613380), received between Mar 26, 2020 and Apr 10, 2026 — classified as 2 deaths, 786 injuries, 4,306 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (820 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 5,094 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Pumping Stopped

  IT WAS REPORTED THAT UNSPECIFIED ALARM OCCURRED. 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 24845768 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ELEVATED BLOOD GLUCOSE (BG) LEVEL OF 550 MG/DL AND KETONES. KETONE LEVEL IDENTIFIED AS LIFE THREATENING BY HEALTHCARE PROVIDER; CAUSE OF BG NOT KNOWN. IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY ADMITTED TO THE INTENSIVE CARE UNIT (ICU). CUSTOMER WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN TO ADDRESS THE ELEVATED BG. CUSTOMER WAS DISCHARGED (B)(6) 2026 WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE. TANDEM TECHNICAL SUPPORT (TTS) OFFERED TO COMPLETE A SYSTEM CHECK, HOWEVER, CUSTOMER DECLINED TO COMPLETE THE CHECK.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 24757746 ↗
• MalfunctionMar 20, 2026Pumping Stopped

  IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING INSULIN DELIVERY. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24654908 ↗
• MalfunctionMar 20, 2026Pumping Stopped

  IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING INSULIN DELIVERY. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24653084 ↗
• MalfunctionMar 20, 2026Pumping Stopped

  IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED WITH MULTIPLE CARTRIDGES. 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 24649549 ↗
• MalfunctionMar 2, 2026Pumping Stopped

  IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING INSULIN DELIVERY. REPORTEDLY, THE CUSTOMER HAD AN ALTERNATE PUMP FOR INSULIN THERAPY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489305 ↗
• MalfunctionMar 2, 2026Pumping Stopped

  IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING INSULIN DELIVERY. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24485242 ↗
• MalfunctionFeb 12, 2026Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE WAKE BUTTON ON THE PUMP WAS EXTREMELY DIFFICULT TO PRESS. 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 24327828 ↗
• MalfunctionFeb 5, 2026Charging Problem

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED ISSUES WITH A PUMP, INCLUDING STUCK BUTTONS, INACCURATE INSULIN DELIVERY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER WAS REFERRED TO TECHNICAL SUPPORT FOR ASSISTANCE WITH THESE ISSUES, BUT NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE OUTCOME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24267458 ↗
• MalfunctionFeb 4, 2026Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE WAKE BUTTON ON THE PUMP WAS DIFFICULT TO PRESS AND REQUIRED MULTIPLE PRESSES IN ORDER TO TURN THE PUMP SCREEN ON. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER CONTINUED USING THE PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259370 ↗
• MalfunctionFeb 3, 2026Premature 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 CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251123 ↗
• MalfunctionJan 30, 2026Pumping Stopped

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225640 ↗
• MalfunctionDec 9, 2025Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE PUMP BATTERY WAS CHARGING SLOWER THAN EXPECTED. 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 23764243 ↗
• MalfunctionDec 9, 2025Mechanical Problem; Mechanical Problem

  CALLER REPORTED A CARTRIDGE ALARM 30, WHICH OCCURRED DURING THE LOAD PROCESS. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE ISSUE WAS RESOLVED AS THE CALLER SUCCESSFULLY LOADED A NEW CARTRIDGE AND RESUMED INSULIN THERAPY. NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING A CARTRIDGE ALARM HISTORY WITH THIS PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756703 ↗
• MalfunctionDec 9, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A DELAY IN THE TOUCHSCREEN RESPONSE WHEN UNLOCKING THE PUMP. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED ANY FOLLOW-UP, AND NO FURTHER DETAILS REGARDING THE OUTCOME OF THE EVENT WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23754049 ↗
• MalfunctionDec 9, 2025False Alarm; False Alarm

  A PUMP DECLARED AN ALTITUDE ALARM, AND THE ISSUE DID NOT HAVE AN ADVERSE IMPACT ON THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S INSULIN WAS SUSPENDED DUE TO THE ALTITUDE ALARM CONDITION, AND DESPITE EFFORTS TO CLEAN THE PUMP'S SPEAKER HOLES AND RECONNECT THE CARTRIDGE, INSULIN COULD NOT BE RESUMED. TECHNICAL SUPPORT INSTRUCTED FURTHER TROUBLESHOOTING STEPS, AND NO NEW CARTRIDGE WAS LOADED AT THAT TIME, WITH FOLLOW-UP SCHEDULED TO CONTINUE ADDRESSING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23753244 ↗
• MalfunctionDec 4, 2025Obstruction of Flow; Obstruction of Flow

  CUSTOMER REPORTED PAST OCCLUSIONS, BUT THERE WERE NO ISSUES WITH SUPPLIES IDENTIFIED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE OUTCOME OF THE EVENT AS THE CUSTOMER DECLINED FOLLOW-UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23723546 ↗
• MalfunctionDec 2, 2025Mechanical Problem; Mechanical Problem

  A CARTRIDGE ALARM WAS REPORTED BY THE CALLER DURING THE LOAD PROCESS, AND IT WAS CONFIRMED THAT THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE ISSUE OCCURRED BECAUSE THE CALLER DID NOT WAIT FOR THE PROMPT TO REMOVE THE USED CARTRIDGE, LEADING TO RECURRING ALARMS, DESPITE EFFORTS TO LOAD A NEW CARTRIDGE. AS A CORRECTIVE ACTION, TECHNICAL SUPPORT EDUCATED THE CALLER ON CORRECT CARTRIDGE LOADING PROCEDURES AND DECIDED TO REPLACE THE PUMP. THE CALLER WILL CONTACT THEIR HEALTHCARE PROVIDER FOR A BACKUP INSULIN THERAPY, AS NONE WAS AVAILABLE. INSTRUCTIONS ON USING STORAGE MODE, RETURNING THE FAULTY PUMP, AND STEPS FOR THE REPLACEMENT PUMP WERE PROVIDED, AND THE CALLER ACKNOWLEDGED THESE INSTRUCTIONS. A REPLACEMENT PUMP WAS DISPATCHED TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692606 ↗
• MalfunctionNov 24, 2025Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  CALLER REPORTED A PROBLEM WITH THE SPEAKER AND VIBRATE FUNCTION OF THEIR PUMP, SPECIFICALLY NOTING THAT THE SPEAKER WAS NOT AUDIBLE. THERE WAS NO 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 23631348 ↗
• MalfunctionNov 20, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE WAKE BUTTON ON THE PUMP WAS STICKING, MAKING IT HARD TO TURN THE PUMP SCREEN ON OR OFF. 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 23613353 ↗
• MalfunctionNov 20, 2025Failure to Charge; Failure to Charge

  IT WAS REPORTED HAVING CHARGING PROBLEMS. THERE WAS NO REPORTED ADVERSE IMPACT. MULTIPLE FOLLOW-UP ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT; HOWEVER, THE CUSTOMER DID NOT RESPOND. NO ADDITIONAL INFORMATION WAS KNOWN OR REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607244 ↗
• MalfunctionNov 19, 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 REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT AND DECLINED TO PROVIDE FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23599095 ↗
• MalfunctionNov 18, 2025Pumping Stopped; Pumping Stopped

  A MALFUNCTION ON THE PUMP WAS REPORTED BY THE CALLER. THERE WAS NO ADVERSE IMPACT ON THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT PROVIDED INFORMATION TO RESET THE PUMP AND ASSISTED THE CALLER WITH THE PROCESS. AFTER RESETTING, THE MALFUNCTION DID NOT RECUR, AND THE CUSTOMER WAS INSTRUCTED TO CONTINUE USING THE PUMP AND TO CALL BACK IF ANY ISSUES OCCURRED AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23585949 ↗
• MalfunctionNov 17, 2025Communication or Transmission Problem; Communication or Transmission Problem

  CALLER REPORTED A CGM ERROR 42. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT GUIDED THE CALLER THROUGH A PUMP RESET, AND AFTER THE RESET, THE ERROR CODE DID NOT REAPPEAR, ALLOWING THE CALLER TO SUCCESSFULLY START THEIR SENSOR SESSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23571568 ↗
• MalfunctionNov 14, 2025Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT A MALFUNCTION OCCURRED ON A PUMP. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER WAS PROVIDED WITH INFORMATION TO RESET THE PUMP AND RECEIVED ASSISTANCE FROM TECHNICAL SUPPORT TO DO SO. AFTER THE RESET, THE MALFUNCTION CODE DID NOT RECUR, AND THE CUSTOMER WAS ADVISED TO CONTINUE USING THE PUMP AND TO CALL BACK IF THE ISSUE HAPPENS AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555617 ↗