t:slim X2 Insulin Pump with Basal-IQ 1009638Recalls & reported problems

Summary

The FDA's MAUDE database contains 458 adverse event reports that list this exact device (DI 00389152000039), received between Oct 19, 2022 and Sep 30, 2026 — classified as 65 injuries, 393 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (140 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 458 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954761 ↗
• MalfunctionSep 29, 2026Failure to Charge

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937909 ↗
• MalfunctionAug 20, 2026Failure to Charge

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50354522 ↗
• MalfunctionJun 25, 2026Charging Problem

  IT WAS REPORTED THAT "THE CHARGING CORD NEEDS EXCESSIVE FORCE TO PLUG IN." THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER. THE CUSTOMER DECLINED TROUBLESHOOTING FURTHER WITH TANDEM TECHNICAL SUPPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25629172 ↗
• MalfunctionJun 9, 2026Scratched Material

  IT WAS REPORTED THAT THE PUMP TOUCHSCREEN WAS SCRATCHED AND 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 25445247 ↗
• MalfunctionJun 8, 2026Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT PUMP TOUCHSCREEN WAS UNRESPONSIVE. 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 25429830 ↗
• MalfunctionMay 29, 2026Pumping Stopped

  IT WAS REPORTED THAT PUMP EXPERIENCED MALFUNCTION AFTER BEING EXPOSED TO HOTTER TEMPERATURES. 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 25337530 ↗
• MalfunctionMay 29, 2026Failure to Charge

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A POWER SOURCE ALERT AFTER PLUGGING THE PUMP INTO A WALL OUTLET. CUSTOMER REPORTED USING A NON-TANDEM PROVIDED WALL ADAPTER WITH A TANDEM-PROVIDED CHARGING CABLE TO CHARGE THE PUMP. 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 25333587 ↗
• MalfunctionMay 28, 2026Date/Time-Related Software Problem

  IT WAS REPORTED THAT THE PUMP TIME WAS INCORRECT, CAUSE WAS UNKNOWN. MULTIPLE ATTEMPTS WERE MADE TO FOLLOW UP WITH THE CUSTOMER REGARDING THE REPORTED ISSUE; HOWEVER, NO RESPONSE FROM THE CUSTOMER WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25317441 ↗
• MalfunctionMay 14, 2026Pumping Stopped

  IT WAS REPORTED THAT PUMP EXPERIENCED MALFUNCTION WITH CODE 16, AND NO EVENTS OCCURRED BEFOREHAND. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER CONTACTED SUPPORT, RECEIVED INSTRUCTIONS TO RESET PUMP, SUCCESSFULLY CLEARED MALFUNCTION WITHOUT RECURRENCE, AND WAS ADVISED TO CONTINUE USING PUMP AND TO CALL BACK IF PROBLEM RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174489 ↗
• MalfunctionMay 12, 2026Incorrect Measurement

  IT WAS REPORTED THAT INSULIN GAUGE ON PUMP DISPLAYED AMOUNT DIFFERENT THAN EXPECTED AND REMAINED AT A STATIC FILL ESTIMATE DESPITE INSULIN BEING DELIVERED. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER WAS EDUCATED THAT THIS COULD OCCUR WHEN THERE WAS LARGE VARIANCE IN MEASURED PRESSURES USED TO CALCULATE REMAINING INSULIN AND THAT ONCE INSULIN AMOUNT MATCHED THE STATIC VALUE THE ESTIMATE WOULD RESUME COUNTING DOWN NORMALLY, AND CALLER UNDERSTOOD AND ACKNOWLEDGED THIS INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25147908 ↗
• InjuryMay 5, 2026Pumping Stopped

  A MALFUNCTION WAS REPORTED ON THE PUMP. THE CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL DISPLAYED AS "HIGH"; ALTHOUGH A SPECIFIC VALUE WAS NOT PROVIDED. A CORRECTION INJECTION (MDI) WAS DELIVERED TO ADDRESS THE ELEVATED BG LEVEL, AND THERE WAS NO NEED FOR THIRD-PARTY ASSISTANCE. 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: Hyperglycemia

  MAUDE report 25084437 ↗
• MalfunctionMay 1, 2026Obstruction of Flow

  IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER RESOLVED ISSUE BY CHANGING INFUSION SET AND CARTRIDGE AND RESUMING INSULIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062301 ↗
• MalfunctionApr 28, 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 ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25023360 ↗
• MalfunctionApr 27, 2026Pumping Stopped

  IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING INSULIN DELIVERY. CUSTOMER WILL CONTINUE TO USE THE CURRENT 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 25010375 ↗
• MalfunctionApr 26, 2026Break

  IT WAS REPORTED THAT AN O-RING WAS ON THE PNEUMATIC TAP. THE CUSTOMER WAS ABLE TO REMOVE THE O-RING FROM THE PUMP AND SUCCESSFULLY RELOADED THE EXISTING CARTRIDGE TO RESUME INSULIN THERAPY. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24993490 ↗
• MalfunctionApr 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 24987947 ↗
• MalfunctionApr 24, 2026Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24984467 ↗
• MalfunctionApr 23, 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. 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 24968469 ↗
• MalfunctionApr 21, 2026Charging Problem

  IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO CHARGE THE PUMP USING THE TANDEM-PROVIDED WALL POWER ADAPTER AND CHARGING CABLE. THERE WAS NO REPORTED IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER WAS ABLE TO SUCCESSFULLY CHARGE THE PUMP USING SECONDARY CHARGING SUPPLIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24937538 ↗
• MalfunctionApr 20, 2026Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT PUMP TOUCHSCREEN BECAME FROZEN AND DID NOT RESPOND, PREVENTING CUSTOMER FROM INTERACTING WITH SCREEN, ALTHOUGH SCREEN WAS NOT PHYSICALLY DAMAGED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER WAS PROVIDED WITH INSTRUCTIONS TO RESET PUMP BUT COULD NOT PERFORM RESET DUE TO CHARGING SUPPLIES NOT WORKING, AND CUSTOMER DECLINED FURTHER FOLLOW-UP, WITH NO ADDITIONAL INFORMATION AVAILABLE REGARDING FINAL OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932328 ↗
• InjuryApr 16, 2026Pumping Stopped

  IT WAS REPORTED THAT PUMP ISSUED REPEATED CARTRIDGE ALARMS, INCLUDING CARTRIDGE ALARM 20, AND CUSTOMER¿S BLOOD GLUCOSE READING SHOWED AS ¿HIGH¿ WITH SPECIFIC VALUE UNKNOWN. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL BEYOND THE HIGH READING AND NO INDICATION OF SEVERE HARM. CUSTOMER DELIVERED CORRECTION BOLUS USING PUMP, DID NOT REQUIRE THIRD-PARTY ASSISTANCE, AND AGREED TO CONTINUE USING PUMP WITH ALTERNATE METHOD IF NEEDED WHILE TANDEM TECHNICAL SUPPORT ARRANGED REPLACEMENT PUMP WITHIN WARRANTY; SUPPORT CONFIRMED SHIPPING DETAILS, INSTRUCTED CUSTOMER TO PLACE OLD PUMP IN STORAGE MODE AND RETURN IT WITHIN 10 DAYS USING PROVIDED MATERIALS, AND ADVISED CUSTOMER TO PROGRAM PUMP SETTINGS AND RECONNECT CONTINUOUS GLUCOSE MONITOR ON REPLACEMENT DEVICE.

  Patient problems: Hyperglycemia

  MAUDE report 24897395 ↗
• MalfunctionApr 14, 2026Pumping Stopped

  IT WAS REPORTED THAT PUMP EXPERIENCED MALFUNCTION WITH NON-RESETTABLE ERROR, AND NO NOTABLE EVENTS OCCURRED BEFORE THE ISSUE. 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 24880199 ↗
• MalfunctionApr 13, 2026Incorrect Measurement

  IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE AND STATIC. CUSTOMER CONTINUED TO USE THE EXISTING CARTRIDGE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24866219 ↗
• MalfunctionApr 13, 2026Incorrect Measurement

  IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. CUSTOMER LOADED A NEW CARTRIDGE TO RESOLVE THE ISSUE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865966 ↗