t:slim X2 Insulin Pump with Basal-IQ 1009640Recalls & reported problems

Summary

The FDA's MAUDE database contains 765 adverse event reports that list this exact device (DI 00389152000046), received between Aug 26, 2022 and Sep 30, 2026 — classified as 78 injuries, 687 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (239 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 765 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Key or Button Unresponsive/not Working

  It was reported that the pump touch screen was unresponsive. 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 50947726 ↗
• MalfunctionSep 29, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938218 ↗
• InjurySep 29, 2026Use of Device Problem

  It was reported that the pump battery was depleting quickly resulting in the pump shutting off. Customer's blood glucose (BG) level was displayed as ¿High¿; however, a specific value was not provided. Customer administered a manual insulin injection to address elevated 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 50937592 ↗
• MalfunctionSep 29, 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 50937537 ↗
• MalfunctionSep 29, 2026Audible Prompt/Feedback Problem

  It was reported that the pump's alarm volume were too low. There was no 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 50934600 ↗
• MalfunctionSep 28, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922390 ↗
• MalfunctionSep 28, 2026Obstruction of Flow

  It was reported that occlusion alarms occurred for about a week while customer used infusion sets, cartridges, and Humalog insulin, and caller changed out supplies about every day and half to address recurring occlusion issues. There was no reported impact to the customer¿s blood glucose level because caller declined to provide this information. Customer changed infusion set and cartridge, resumed insulin. Technical Support offered to complete as systems check with the customer, however, the customer declined to troubleshoot.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917073 ↗
• MalfunctionAug 20, 2026Failure to Charge

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50359201 ↗
• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported intermittently that the customer required several emergency room (ER) visits to assistance and treat elevated blood glucose levels (value not provided). Reportedly, the customer experienced diabetic ketoacidosis. No additional information was provided. Multiple contact attempts were made by Tandem Technical Support to obtain additional information regarding the event; however, no response was received from the customer.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 50331164 ↗
• 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 50325150 ↗
• MalfunctionAug 19, 2026Overheating of Device

  It was reported that pump became hot to touch while charging, even though no temperature alarms were recorded, and customer was using Tandem charging supplies. There was no adverse impact to the customer¿s blood glucose level. Customer planned to use multiple daily injections as backup insulin therapy. Technical Support arranged shipment of replacement pump and advised customer to reprogram pump settings and reconnect continuous glucose monitor to replacement pump.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50323810 ↗
• MalfunctionAug 18, 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 50307624 ↗
• MalfunctionAug 7, 2026Failure to Charge

  It was reported that the pump battery could not be charged. 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 50179760 ↗
• MalfunctionJul 10, 2026Incorrect Measurement

  IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING. THERE WAS NO 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 25780629 ↗
• MalfunctionJul 10, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A CONTINUOUS GLUCOSE MONITOR ERROR 42. THE PUMP WAS RESET, AND THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25780346 ↗
• MalfunctionJul 6, 2026Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE. THERE WAS NO ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL. DURING TROUBLESHOOTING WITH TECHNICAL SUPPORT, THE PUMP WAS RESET, AND THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25719184 ↗
• MalfunctionJul 5, 2026Priming Problem

  IT WAS REPORTED THAT INSULIN DRIPS WERE NOT OBSERVED TO BE EXITING THE TUBING DURING THE LOAD FILL PROCESS. REPORTEDLY, THE CARTRIDGE WAS CHANGED TO ADDRESS THE ISSUE AND INSULIN DELIVERY WAS RESUMED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25713047 ↗
• MalfunctionJul 2, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT CUSTOMER EXPERIENCED CONTINUOUS GLUCOSE MONITOR ERROR AND WAS UNABLE TO START SENSOR SESSION. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT GUIDED CUSTOMER THROUGH COMPLETE PUMP RESET, ERROR DID NOT RECUR, AND CUSTOMER SUCCESSFULLY STARTED NEW SENSOR SESSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25691991 ↗
• 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. 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 25674112 ↗
• MalfunctionJun 30, 2026Incorrect Measurement

  IT WAS REPORTED THAT CUSTOMER RECEIVED MINIMUM FILL NOTIFICATION WHILE ATTEMPTING TO LOAD NEW CARTRIDGE AND HAD SUFFICIENT USABLE INSULIN REMAINING. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER REPLACED CARTRIDGE AND INFUSION SET, RESUMED INSULIN THERAPY WITH NEW SUPPLIES, AND REQUESTED REPLACEMENTS, AND TECHNICAL SUPPORT EXPLAINED THAT SUPPLIES WERE INTERCHANGEABLE, CLARIFIED THAT NOT ALL COMPONENTS NEEDED TO BE CHANGED IF ONLY ONE WAS COMPROMISED, AND SENT GOODWILL REPLACEMENT ORDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25664955 ↗
• MalfunctionJun 25, 2026Pumping Stopped

  IT WAS REPORTED THAT INTERMITTENT UNSPECIFIED MALFUNCTION ALARMS OCCURRED, REQUIRING PUMP RESETS IN ORDER TO RESTORE PUMP FUNCTION. 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 25626032 ↗
• MalfunctionJun 23, 2026Pumping Stopped

  IT WAS REPORTED THAT PUMP EXPERIENCED MALFUNCTION ALARM WITH CODE MALF 0 WITH NO NOTABLE EVENTS OCCURRING BEFOREHAND. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER CONTACTED SUPPORT, WAS GUIDED THROUGH PUMP RESET, CONFIRMED MALFUNCTION DID NOT RECUR AFTER RESET, AND WAS INSTRUCTED TO CONTINUE USING PUMP AND TO CALL BACK IF MALFUNCTION APPEARED AGAIN, WHICH CUSTOMER ACKNOWLEDGED AND UNDERSTOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25599307 ↗
• MalfunctionJun 22, 2026Incorrect Measurement

  IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER RELOADED THE CARTRIDGE IN ATTEMPT TO RESOLVE ISSUE; HOWEVER, THE ISSUE PERSISTED. REPORTEDLY, THE CUSTOMER DECLINED FURTHER TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT; THEREFORE, NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25582002 ↗
• MalfunctionJun 18, 2026Obstruction of Flow

  IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED. REPORTEDLY, THE CUSTOMER HAD BEEN USING THE SAME CARTRIDGE AND INFUSION SET FOR OVER 2 DAYS USING HUMALOG INSULIN. TANDEM CUSTOMER TECHNICAL SUPPORT INFORMED CUSTOMER THAT HUMALOG INSULIN IS INDICATED FOR USE WITH TANDEM SUPPLIES FOR 2 DAYS. CUSTOMER CHANGED CARTRIDGE ONLY AND RESUMED INSULIN TO ADDRESS THE ISSUE. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25552459 ↗
• MalfunctionJun 18, 2026Incorrect Measurement

  IT WAS REPORTED THAT PUMP DISPLAYED MINIMUM FILL NOTIFICATION WHILE CUSTOMER ATTEMPTED TO LOAD CARTRIDGE WITH USABLE INSULIN REMAINING. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT GUIDED LOADING OF NEW CARTRIDGE USING PROPER TECHNIQUE, AND CALLER SUCCESSFULLY LOADED CARTRIDGE AND RESUMED INSULIN DELIVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25549899 ↗