t:slim X2 Insulin Pump with Basal-IQ 1009636Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,403 adverse event reports that list this exact device (DI 00389152000015), received between Sep 27, 2022 and Sep 29, 2026 — classified as 140 injuries, 1,263 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (528 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 1,403 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938528 ↗
• MalfunctionSep 29, 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'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 50935885 ↗
• MalfunctionSep 29, 2026Pumping Stopped

  It was reported that pump malfunction alarm occurred. There was no adverse impact to the customer¿s blood glucose level. Caller had no backup insulin therapy available and planned to contact healthcare provider, and Technical Support arranged replacement pump under warranty, confirmed shipping details, instructed caller to place pump in storage mode, and advised caller to return malfunctioning pump within 10 days and to program pump settings into replacement pump.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927048 ↗
• MalfunctionSep 28, 2026Incorrect Measurement

  It was reported that a minimum fill notification occurred after the user filled the cartridge with (b)(4) units of insulin during the load sequence. 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 50917116 ↗
• MalfunctionSep 1, 2026Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50540608 ↗
• MalfunctionSep 1, 2026Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50540600 ↗
• MalfunctionAug 20, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50351521 ↗
• MalfunctionAug 19, 2026Key or Button Unresponsive/not Working

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50326704 ↗
• MalfunctionAug 4, 2026Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50132054 ↗
• MalfunctionJul 27, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50012796 ↗
• MalfunctionJul 7, 2026Pumping Stopped

  IT WAS REPORTED THAT PUMP EXPERIENCED MALFUNCTION WITH CODE 6, AND NO NOTABLE EVENTS OCCURRED PRIOR TO THE ISSUE. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER RECEIVED INSTRUCTIONS FROM TECHNICAL SUPPORT TO RESET PUMP, COMPLETED RESET SUCCESSFULLY WITH NO RECURRENCE OF MALFUNCTION, WAS ADVISED TO CONTINUE USING PUMP, AND WAS INSTRUCTED TO CALL BACK IF MALFUNCTION CODES APPEARED AGAIN, WHICH CUSTOMER ACKNOWLEDGED AND UNDERSTOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25737710 ↗
• MalfunctionJul 6, 2026Data Problem

  IT WAS REPORTED THAT THE PUMP INDICATED A DATA LOG CORRUPTION. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT PROVIDED PUMP RESET INFORMATION, BUT THE CUSTOMER DECLINED FURTHER FOLLOW UP FROM TANDEM TECHNICAL SUPPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25718332 ↗
• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM WITH A BLOOD GLUCOSE (BG) LEVEL BETWEEN 450-550 MG/DL ON (B)(6) 2026. CAUSE WAS NOT KNOWN. CUSTOMER WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN TO ADDRESS THE ELEVATED BG. CUSTOMER WAS DISCHARGED ON (B)(6) 2026 WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE.

  Patient problems: Hyperglycemia

  MAUDE report 25689207 ↗
• MalfunctionJul 1, 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 25679950 ↗
• MalfunctionJul 1, 2026Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE WAKE BUTTON WAS STICKING. 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 25679326 ↗
• MalfunctionJun 30, 2026Pumping Stopped

  IT WAS REPORTED THAT PUMP EXPERIENCED MALFUNCTION ALARM WITH CODE MALF 0, AND NO NOTABLE EVENTS OCCURRED BEFORE ISSUE. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT PROVIDED PUMP RESET INSTRUCTIONS, ASSISTED CALLER IN RESETTING PUMP, CONFIRMED MALFUNCTION DID NOT RECUR, ADVISED CUSTOMER TO CONTINUE USING PUMP, AND INSTRUCTED CUSTOMER TO CALL BACK IF MALFUNCTION ALARM APPEARED AGAIN, WHICH CALLER ACKNOWLEDGED AND UNDERSTOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25671519 ↗
• MalfunctionJun 30, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PUMP TOUCHSCREEN WAS ON, BUT THE DISPLAY REMAINED BLACK. 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 25665247 ↗
• MalfunctionJun 29, 2026Pumping Stopped

  IT WAS REPORTED THAT PUMP EXPERIENCED MALFUNCTION WITH CODE 9 AND FAULT ID 0X20F1, WITH NO NOTABLE EVENTS OCCURRING BEFORE ISSUE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER CONTACTED SUPPORT, WAS GUIDED THROUGH RESETTING PUMP, DID NOT EXPERIENCE REPEAT OF MALFUNCTION, WAS ADVISED TO CONTINUE USING PUMP, AND WAS INSTRUCTED TO CALL BACK IF MALFUNCTION RECURRED, WHICH CUSTOMER ACKNOWLEDGED AND UNDERSTOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25658398 ↗
• MalfunctionJun 29, 2026Pumping Stopped

  IT WAS REPORTED THAT PUMP EXPERIENCED MALFUNCTION ALARM WITH MALFUNCTION CODE DISPLAYED. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT GUIDED CUSTOMER THROUGH PUMP RESET PROCESS, CONFIRMED THAT MALFUNCTION DID NOT RECUR AFTER RESET, ADVISED CUSTOMER TO CONTINUE USING PUMP, AND INSTRUCTED CUSTOMER TO CALL BACK IF MALFUNCTION OCCURRED AGAIN, WHICH CUSTOMER ACKNOWLEDGED AND UNDERSTOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25650233 ↗
• MalfunctionJun 25, 2026Failure to Charge

  IT WAS REPORTED THAT PUMP BATTERY DID NOT CHARGE EVEN THOUGH CUSTOMER USED TANDEM CHARGING CABLE, WALL ADAPTER, AND WORKING POWER OUTLET, AND PUMP DISPLAYED POWER SOURCE ALERT. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER WAS INSTRUCTED TO LEAVE WALL ADAPTER PLUGGED INTO KNOWN WORKING OUTLET FOR AT LEAST 30 MINUTES, AND DURING FOLLOW-UP CUSTOMER REPORTED THAT PUMP BEGAN CHARGING WITHOUT CHANGING CHARGING SUPPLIES, PUMP DID NOT SHUT DOWN OR BECOME UNABLE TO TURN BACK ON, AND NO FURTHER ASSISTANCE WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25619426 ↗
• MalfunctionJun 24, 2026Pumping Stopped

  A MALFUNCTION WAS REPORTED ON THE PUMP. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT PROVIDED INFORMATION TO RESET THE PUMP, ASSISTED THE CALLER WITH THE RESET, AND CONFIRMED THAT THE MALFUNCTION CODE DID NOT RECUR. THE CUSTOMER WAS ADVISED TO CONTINUE USING THE PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25610654 ↗
• MalfunctionJun 24, 2026Charging Problem

  IT WAS REPORTED THAT T:SLIM X2 PUMP BATTERY WOULD NOT CHARGE WHILE USING TANDEM CHARGING CABLE WITH NON-TANDEM WALL ADAPTER, AND NO POWER SOURCE ALERTS APPEARED IN PUMP HISTORY. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER WAS INSTRUCTED TO LEAVE WALL ADAPTER PLUGGED INTO A WORKING OUTLET FOR AT LEAST 30 MINUTES, LATER CONFIRMED THAT PUMP BEGAN CHARGING AFTER SWITCHING TO A DIFFERENT, NON-TANDEM CHARGING CABLE AND NON-TANDEM WALL ADAPTER, WAS ADVISED THAT THIRD-PARTY CHARGING SUPPLIES WERE NOT RECOMMENDED EXCEPT FOR TROUBLESHOOTING, ACKNOWLEDGED THIS GUIDANCE, AND WAS SENT REPLACEMENT TANDEM CHARGING SUPPLIES, AFTER WHICH NO FURTHER ASSISTANCE WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25609651 ↗
• MalfunctionJun 18, 2026Pumping Stopped

  IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED ON THE PUMP. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT ASSISTED THE CALLER IN RESETTING THE PUMP, AND MALFUNCTION CODE DID NOT RECUR THEREAFTER. THE CUSTOMER WAS ADVISED TO CONTINUE USING THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25549871 ↗
• InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM WITH A BLOOD GLUCOSE (BG) LEVEL BETWEEN 550-559 MG/DL ON (B)(6) 2026. CAUSE WAS NOT KNOWN. CUSTOMER WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN TO ADDRESS THE ELEVATED BG. CUSTOMER WAS DISCHARGED ON (B)(6) 2026 WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE.

  Patient problems: Hyperglycemia

  MAUDE report 25547719 ↗
• MalfunctionJun 16, 2026Obstruction of Flow

  IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUE. THERE WAS NO ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25519587 ↗