t:slim X2 Insulin Pump with Control-IQ 1009642Recalls & reported problems

Summary

The FDA's MAUDE database contains 10,004 adverse event reports that list this exact device (DI 00389152000084), received between Aug 18, 2022 and Sep 30, 2026 — classified as 1 death, 989 injuries, 9,014 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (3,195 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. Jul 21, 2025Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 10,004 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Charge

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952492 ↗
• InjurySep 30, 2026False Alarm

  It was reported that pump displayed altitude alarm 21 and insulin delivery was suspended, and customer could not give insulin dose because pump would not allow it; customer¿s blood glucose reading showed ¿High,¿ but exact value was unknown. There was adverse impact to the customer¿s blood glucose level, and value exceeded 500 mg/dL, but specific value was not reported. Customer did not seek help from another healthcare provider, and technical support guided customer to remove obstruction from speaker holes, clean area, remove and reconnect cartridge, and wait to resume insulin; insulin delivery successfully resumed, alarm did not recur, pump returned to normal operation, and technical support provided tips to prevent future altitude alarms.

  Patient problems: Hyperglycemia

  MAUDE report 50950250 ↗
• MalfunctionSep 29, 2026Key or Button Unresponsive/not Working

  It was reported that the wake button on the pump was 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 50934985 ↗
• MalfunctionSep 29, 2026Charging Problem

  It was reported that customer experienced issues plugging charging cable into charging port indicating unspecified issues with the USB port on the pump. There was no reported impact to the customer¿s blood glucose level. Customer declined further assistance, and technical support was unable to obtain additional information, so no further action was taken.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934982 ↗
• MalfunctionSep 28, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925111 ↗
• MalfunctionSep 28, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925108 ↗
• MalfunctionSep 28, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924502 ↗
• MalfunctionSep 28, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922338 ↗
• InjurySep 28, 2026Pumping Stopped

  Patient problems: Hyperglycemia

  MAUDE report 50915092 ↗
• MalfunctionAug 20, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50355447 ↗
• MalfunctionAug 20, 2026Audible Prompt/Feedback Problem

  It was reported that pump speaker did not work at times, customer could not hear alarms or alerts, and battery life was diminished. There was no reported impact to the customer¿s blood glucose level. Customer declined assistance from Technical Support, and no actions were taken other than documentation of event, with no additional information received regarding the outcome of the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50351540 ↗
• InjuryAug 20, 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 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. The pump was replaced to resolve the issue, and the customer will use MDI as a backup therapy until the replacement arrives.

  Patient problems: Hyperglycemia

  MAUDE report 50342994 ↗
• MalfunctionAug 19, 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 troubleshooting with Tandem Technical Support, therefore no additional information could be obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50325143 ↗
• MalfunctionAug 17, 2026Loose or Intermittent Connection; Charging Problem

  It was reported that charging port on pump appeared worn out and customer had to hold charging cord in place to charge device, causing concern that pump might stop charging. There was no reported impact to the customer¿s blood glucose level. Customer declined troubleshooting and no additional information was obtained, and CTS took no further action and noted that pump in active use at time of report.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50279370 ↗
• InjuryAug 6, 2026Obstruction of Flow

  It was reported that ongoing intermittent occlusion alarms occurred. Customer changed pump supplies to address the issue. Customer¿s blood glucose (BG) level was displayed as "High"; however, specific value was not provided. Elevated BG was addressed by a correction bolus via the pump.

  Patient problems: Hyperglycemia

  MAUDE report 50166857 ↗
• InjuryJul 31, 2026Priming Problem

  It was reported that insulin drips were not observed to be exiting the infusion set tubing during the load fill process. The customer¿s blood glucose (BG) level was displayed as ¿High¿; however, a specific value was not provided. BG level was addressed with a correction bolus via the pump. Reportedly, the cartridge was changed to address the issue and insulin delivery was resumed.

  Patient problems: Hyperglycemia

  MAUDE report 50104127 ↗
• InjuryJul 30, 2026Use of Device Problem

  It was reported that the pump battery was depleting quickly resulting in the pump shutting off. The customer¿s blood glucose (BG) level was displayed as ¿High¿; however, a specific value was not provided. A correction injection was administered to address the BG. Troubleshooting with Tandem Technical Support indicated that pump battery was depleting normally based on settings and customer usage. The customer continued to use the pump for insulin therapy.

  Patient problems: Hyperglycemia

  MAUDE report 50083626 ↗
• MalfunctionJul 9, 2026Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT POWER AND DISPLAY BUTTON WAS NOT RESPONSIVE. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED TRANSFER TO TECHNICAL SUPPORT DURING CALL, AND NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING FURTHER ACTIONS OR OUTCOME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25771702 ↗
• MalfunctionJul 9, 2026Obstruction of Flow

  IT WAS REPORTED THAT ONGOING INTERMITTENT OCCLUSION ALARMS OCCURRED. 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 25766324 ↗
• MalfunctionJul 9, 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. 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 25766084 ↗
• MalfunctionJul 9, 2026Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE WAKE BUTTON WAS STICKING. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING ACTIONS TAKEN BY THE CUSTOMER OR TECHNICAL SUPPORT IN RESPONSE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25765157 ↗
• MalfunctionJul 9, 2026Pumping Stopped

  IT WAS REPORTED THAT PUMP EXPERIENCED MALFUNCTION ALARM, AND CALLER CONFIRMED NO NOTABLE EVENTS OCCURRED BEFOREHAND. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT ASSISTED CALLER WITH RESETTING PUMP AND RECONNECTING CONTINUOUS GLUCOSE MONITOR, ADVISED THAT PUMP COULD CONTINUE TO BE USED, AND INSTRUCTED CALLER TO CALL BACK IF MALFUNCTION RECURRED, WHICH CALLER ACKNOWLEDGED AND UNDERSTOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25765113 ↗
• MalfunctionJul 9, 2026Pumping Stopped

  IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. DURING TROUBLESHOOTING WITH TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED, AND INSULIN DELIVERY WAS RESUMED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25764746 ↗
• MalfunctionJul 9, 2026Pumping Stopped

  IT WAS REPORTED THAT CARTRIDGE ALARM OCCURRED WHILE CUSTOMER WAS USING PUMP AND LOADING WAS AFFECTED, WITH NO PREVIOUS SIMILAR ALARMS ON THIS PUMP. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER, WHO HAD BEEN USING COLD INSULIN, RELOADED CARTRIDGE ON PUMP USING GUIDANCE FROM TECHNICAL SUPPORT, SUCCESSFULLY RESUMED INSULIN THERAPY, AND PLANNED TO USE ROOM TEMPERATURE INSULIN FOR FUTURE CARTRIDGE LOADS, AND ISSUE WAS CONSIDERED RESOLVED; NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING ANY FURTHER OUTCOMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25763476 ↗
• MalfunctionJul 9, 2026Pumping Stopped

  IT WAS REPORTED THAT CUSTOMER EXPERIENCED CARTRIDGE ALARM 20 WHILE USING PUMP AND HAD ALREADY LOADED NEW CARTRIDGE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER FOLLOWED SUPPORT GUIDANCE TO PERFORM AIR REMOVAL STEPS AND CLEAN PNEUMATIC TAP, THEN SUCCESSFULLY LOADED CARTRIDGE, RESUMED INSULIN THERAPY, AND ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25763474 ↗