t:slim X2 Insulin Pump with Basal-IQ 1009639Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 00389152000022), received between Feb 14, 2023 and Aug 4, 2026 — classified as 7 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (26 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. Jul 21, 2025Class IOpen, Classified

   Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a hyperglycemic event, which may lead to injury and/or hospitalization.

   Z-2343-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2026Failure to Charge; Pumping Stopped

  It was reported that the pump battery could not be charged which resulted in the pump shutting down. The customer's blood glucose (BG) level was "High", although a specific value was not given. At time of troubleshooting customer had taken no action to address BG level. The customer reverted to an alternate method of insulin therapy.

  Patient problems: Hyperglycemia

  MAUDE report 50136058 ↗
• MalfunctionJul 9, 2026Pumping Stopped

  IT WAS REPORTED THAT PUMP EXPERIENCED MALFUNCTION ALARM WITH NO NOTABLE EVENTS OCCURRING BEFOREHAND. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT PROVIDED PUMP RESET INSTRUCTIONS, AND CUSTOMER PLANNED TO INDEPENDENTLY RESET PUMP AT HOME WHEN CHARGER WAS AVAILABLE AND TO CALL BACK IF ISSUE CONTINUED, WITH NO ADDITIONAL INFORMATION RECEIVED REGARDING OUTCOME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25763443 ↗
• MalfunctionJul 7, 2026Audible Prompt/Feedback Problem

  IT WAS REPORTED THAT "PUMP WAS NOT ALERTING FOR ALARMS". 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 25730821 ↗
• MalfunctionJun 30, 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 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 25667941 ↗
• MalfunctionApr 3, 2026Obstruction of Flow

  IT WAS REPORTED THAT OCCLUSION ALARMS 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 24777567 ↗
• MalfunctionMar 24, 2026Pumping Stopped

  IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER PERFORMED A PUMP RESET INDEPENDENTLY, CLEARING THE MALFUNCTION ALARM AND WILL CONTINUE TO USE CURRENT PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674617 ↗
• MalfunctionMar 13, 2026False Alarm

  IT WAS REPORTED THAT AN ALTITUDE ALARM OCCURRED. REPORTEDLY, THE PUMP WAS NOT OUTSIDE THE LABELED ALTITUDE OPERATING RANGE. THE CUSTOMER'S BLOOD GLUCOSE WAS 417 MG/DL. REPORTEDLY A NEW CARTRIDGE WAS LOADED, AND INSULIN DELIVERY WAS RESUMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24598919 ↗
• MalfunctionFeb 3, 2026Communication or Transmission Problem

  A CALLER REPORTED AN ISSUE WITH A CGM ERROR 42 RELATED TO A G6 SENSOR. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT PROVIDED COMPLETE PUMP RESET INFORMATION AND GUIDED THE CALLER THROUGH THE RESET PROCESS. AFTER THE RESET, THE CGM ERROR DID NOT REAPPEAR, AND THE CALLER SUCCESSFULLY STARTED THEIR SENSOR SESSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245936 ↗
• MalfunctionJan 22, 2026Charging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24154376 ↗
• MalfunctionJan 6, 2026Charging Problem

  IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO CHARGE THE PUMP USING THE TANDEM-PROVIDED WALL POWER ADAPTER. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER WAS ABLE TO SUCCESSFULLY CHARGE THE PUMP USING A SECONDARY WALL POWER ADAPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23979807 ↗
• MalfunctionNov 25, 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. 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 23641104 ↗
• MalfunctionNov 14, 2025Pumping Stopped; Pumping Stopped

  A CALLER REPORTED A MALFUNCTION ON THEIR INSULIN PUMP, IDENTIFIED BY MALFUNCTION CODE MALF 12. 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 23553484 ↗
• MalfunctionOct 27, 2025Pumping Stopped; Pumping Stopped

  A CALLER REPORTED A MALFUNCTION ON THE PUMP, DISPLAYING A MALFUNCTION CODE AND FAULT ID. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL AS IT DID NOT EXCEED 500 MG/DL (27.7 MMOL/L). TECHNICAL SUPPORT PROVIDED PUMP RESET INFORMATION AND ASSISTED THE CALLER IN RESETTING THE PUMP, AFTER WHICH THE MALFUNCTION CODE DID NOT RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390728 ↗
• MalfunctionOct 23, 2025Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED ON A PUMP. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER WAS ASSISTED BY TECHNICAL SUPPORT TO RESET THE PUMP, AND AFTER RESETTING, THE MALFUNCTION CODE DID NOT RECUR. THE CUSTOMER WAS INSTRUCTED TO CONTINUE USING THE PUMP AND TO CALL BACK IF THE ISSUE HAPPENS AGAIN, WHICH THEY ACKNOWLEDGED AND UNDERSTOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368200 ↗
• MalfunctionSep 19, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED AN OCCLUSION ALARM OCCURRED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED TO CONTINUE TROUBLESHOOTING THE ISSUE WITH TANDEM TECHNICAL SUPPORT, THEREFORE NO ADDITIONAL INFORMATION WAS OBTAINED. THE CUSTOMER CHANGED SUPPLIES AND RESUMED INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23102667 ↗
• MalfunctionAug 14, 2025Pumping Stopped; Pumping Stopped

  A MALFUNCTION ALARM WAS REPORTED ON THE CUSTOMER'S INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL DID NOT EXCEED 500 MG/DL, INDICATING THERE WAS NO ADVERSE IMPACT. TO ADDRESS THE ISSUE, THE CUSTOMER PLANNED TO USE MULTIPLE DAILY INJECTIONS (MDI) AS BACKUP THERAPY WHILE TECHNICAL SUPPORT ARRANGED FOR A REPLACEMENT PUMP WITH UPDATED SOFTWARE. INSTRUCTIONS WERE PROVIDED FOR RETURNING THE FAULTY PUMP AND FOR USING THE NEW EQUIPMENT EFFECTIVELY, WHICH THE CUSTOMER UNDERSTOOD AND ACKNOWLEDGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22811830 ↗
• InjuryJun 30, 2025Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING INSULIN DELIVERY. CUSTOMER'S CONTINUOUS GLUCOSE MONITOR READ "HIGH", HOWEVER, A SPECIFIC BLOOD GLUCOSE (BG) VALUE WAS NOT PROVIDED. A CORRECTION BOLUS VIA PUMP WAS ADMINISTERED TO ADDRESS THE BG LEVEL. CUSTOMER LOADED A NEW CARTRIDGE TO RESOLVE THE ISSUE HOWEVER THE CARTRIDGE ALARM KEPT RECURRING. REPORTEDLY, THE CUSTOMER CONTACTED THE HEALTHCARE PROVIDER TO OBTAIN ALTERNATE INSULIN THERAPY.

  Patient problems: Hyperglycemia

  MAUDE report 22363878 ↗
• InjuryJun 20, 2025Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE PUMP BATTERY TAKES LONGER TO CHARGE. 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 22296749 ↗
• MalfunctionJun 18, 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. THE CUSTOMER DECLINED FURTHER FOLLOW-UP FROM TECHNICAL SUPPORT AND IS CURRENTLY OUT OF WARRANTY BUT IN THE PROCESS OF RENEWAL. NO ADDITIONAL INFORMATION REGARDING CORRECTIVE ACTIONS WAS OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22283837 ↗
• MalfunctionMay 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  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 WOULD LOAD THE CARTRIDGE TO ADDRESS THE EVENT. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080730 ↗
• MalfunctionMar 26, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE PUMP BATTERY WAS UNRESPONSIVE. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. THERE WAS NO ADVERSE IMPACT TO CUSTOMER'S BLOOD GLUCOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21694760 ↗
• MalfunctionFeb 13, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. THERE WAS NO 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 21377413 ↗
• MalfunctionFeb 7, 2025Incorrect Measurement; Pumping Stopped; Incorrect Measurement; Pumping Stopped

  T WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING RESULTING IN THE PUMP SHUTTING DOWN. THERE WAS NO REPORTED ADVERSE IMPACT TO 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 21334469 ↗
• MalfunctionFeb 3, 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 21294812 ↗
• MalfunctionFeb 3, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A POWER SOURCE ALERT AFTER PLUGGING THE PUMP INTO A WALL OUTLET. REPORTEDLY, THE ALERT CLEARED, AND THE PUMP SUCCESSFULLY BEGAN CHARGING AFTER LEAVING THE PUMP PLUGGED INTO THE POWER SOURCE. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293647 ↗