t:slim X2 Insulin Pump with Basal-IQ 1005698Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,316 adverse event reports that list this exact device (DI 00850006613373), received between May 22, 2020 and Jul 8, 2026 — classified as 130 injuries, 1,186 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (309 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. May 24, 2022Class IIOpen, Classified

   Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, 4) Unexpected Open Loop, that can be mitigated with a software update. Issues could result in hypoglycemia, hyperglycemia or diabetic ketoacidosis.

   Z-1811-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,316 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2026Use of Device Problem

  IT WAS REPORTED THAT INSULIN PUMP DID NOT RECOGNIZE CARTRIDGE. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED FOLLOW UP WITH TECHNICAL SUPPORT, NO TROUBLESHOOTING WAS PERFORMED, AND NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE OUTCOME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25749063 ↗
• MalfunctionJul 7, 2026Material Separation

  IT WAS REPORTED THAT POWER BUTTON BROKE OFF. 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 25738369 ↗
• MalfunctionJun 25, 2026Failure to Charge; Pumping Stopped

  IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED WHICH RESULTED IN THE PUMP SHUTTING DOWN. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25619595 ↗
• MalfunctionJun 12, 2026Failure to Charge; Pumping Stopped

  IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED WHICH RESULTED IN THE PUMP SHUTTING DOWN. 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 25486575 ↗
• MalfunctionJun 12, 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 25484780 ↗
• MalfunctionJun 3, 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. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25376805 ↗
• InjuryMay 1, 2026Pumping Stopped

  IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING INSULIN DELIVERY. THE CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS DISPLAYED AS "HIGH"; HOWEVER, NO SPECIFIC VALUE WAS PROVIDED. CUSTOMER DELIVERED A CORRECTION BOLUS TO ADDRESS BG. CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.

  Patient problems: Hyperglycemia

  MAUDE report 25055600 ↗
• MalfunctionApr 17, 2026Mechanical Problem

  IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING THE LOAD SEQUENCE. CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918538 ↗
• MalfunctionApr 9, 2026Failure to Charge

  IT WAS REPORTED THAT THE PUMP BATTERY "WAS CHARGING SLOW". 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 24832902 ↗
• InjuryApr 3, 2026Pumping Stopped

  IT WAS REPORTED THAT PUMP MALFUNCTION OCCURRED WITHOUT ANY NOTABLE EVENTS BEFOREHAND. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS DISPLAYED AS "HIGH"; HOWEVER, SPECIFIC VALUE WAS NOT PROVIDED. CUSTOMER GAVE CORRECTION INJECTION USING MULTIPLE DAILY INJECTIONS, DID NOT REQUIRE ASSISTANCE FROM A 3RD PARTY, RECEIVED INSTRUCTIONS FROM TECHNICAL SUPPORT TO RESET PUMP, SUCCESSFULLY CLEARED MALFUNCTION WITHOUT RECURRENCE, AND WAS ADVISED TO CONTINUE USING PUMP AND CALL BACK IF MALFUNCTION HAPPENED AGAIN.

  Patient problems: Hyperglycemia

  MAUDE report 24779666 ↗
• MalfunctionMar 2, 2026Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE WAKE BUTTON ON THE PUMP WAS DIFFICULT TO PRESS AND REQUIRED MULTIPLE PRESSES IN ORDER TO TURN THE PUMP SCREEN ON. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER CONTINUED USING THE PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484522 ↗
• InjuryFeb 24, 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 THAT WAS DISPLAYED AS "HIGH", ALTHOUGH SPECIFIC VALUE WAS NOT PROVIDED. CUSTOMER ADDRESSED ELEVATED BG BY A CORRECTION INJECTION VIA MANUAL INSULIN THERAPY. 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 24427386 ↗
• MalfunctionFeb 12, 2026Overheating of Device

  IT WAS REPORTED THAT THE PUMP WAS WARM TO THE TOUCH DESPITE BEING IN ROOM-TEMPERATURE CONDITIONS. REPORTEDLY, THE PUMP WAS CHARGING DURING THE EVENT. 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 24322209 ↗
• MalfunctionFeb 10, 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. CUSTOMER DECLINED TO TROUBLESHOOT WITH TANDEM TECHNICAL SUPPORT; THEREFORE NO ADDITIONAL INFORMATION COULD BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306655 ↗
• InjuryFeb 3, 2026Priming Problem

  CALLER REPORTED NOT SEEING DROPS OF INSULIN AT THE END OF THE TUBING DURING THE FILL TUBING STEP OF THE LOAD SEQUENCE. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS DISPLAYED AS "HIGH"; HOWEVER, SPECIFIC VALUE WAS NOT PROVIDED. ELEVATED BG WAS ADDRESS BY A MANUAL INSULIN INJECTION AND DID NOT REQUIRE ASSISTANCE FROM A THIRD PARTY. IT WAS AGREED THE CALLER WOULD LOAD A NEW CARTRIDGE AND CALL BACK IF THE ISSUE CONTINUED.

  Patient problems: Hyperglycemia

  MAUDE report 24252248 ↗
• InjuryJan 23, 2026Obstruction of Flow

  IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS "HIGH", ALTHOUGH SPECIFIC VALUE WAS NOT PROVIDED ON 1/18/2026. THE ELEVATED BG WAS ADDRESSED BY A CORRECTION BOLUS VIA THE PUMP. THE CUSTOMER RESOLVED THE OCCLUSION ISSUE BY CHANGING THE INFUSION SET AND CARTRIDGE BEFORE RESUMING INSULIN DELIVERY.

  Patient problems: Hyperglycemia

  MAUDE report 24172755 ↗
• MalfunctionJan 23, 2026Incorrect Measurement

  IT WAS REPORTED THAT THE DEVICE EXPERIENCED AN ISSUE DESCRIBED AS "BATTERY JUMPS." THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED FURTHER INQUIRY OR ASSISTANCE, AND NO FURTHER ACTION WAS REQUIRED OR TAKEN BY TECHNICAL SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159612 ↗
• MalfunctionJan 23, 2026Mechanical Problem

  A CARTRIDGE CHANGE ERROR WAS REPORTED WITH A PUMP. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER, WITH THE ASSISTANCE OF TECHNICAL SUPPORT, REMOVED THE CARTRIDGE, INSPECTED AND CLEANED THE PUMP, AND FOLLOWED ON-SCREEN INSTRUCTIONS. ALTHOUGH THE INITIAL ATTEMPT TO LOAD THE CARTRIDGE WAS UNSUCCESSFUL, WITH FURTHER GUIDANCE, THE CUSTOMER SUCCESSFULLY LOADED A NEW CARTRIDGE AND RESUMED INSULIN DELIVERY. A REPLACEMENT CARTRIDGE WAS SENT TO THE CUSTOMER AS A PRECAUTION DUE TO DISCOMFORT WITH USING THE REMAINING CARTRIDGES FROM THE SAME BATCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159543 ↗
• MalfunctionJan 15, 2026Mechanical Problem

  IT WAS REPORTED THAT A CARTRIDGE CHANGE ERROR OCCURRED. THE CUSTOMER LOADED A NEW CARTRIDGE TO RESOLVE 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 24086968 ↗
• MalfunctionJan 15, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT A BATTERY DEPLETED WITHIN A DAY. 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 24081188 ↗
• MalfunctionJan 6, 2026Failure to Charge

  IT WAS REPORTED THAT THE PUMP WAS HAVING "CHARGING ISSUES". 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 23972642 ↗
• MalfunctionDec 23, 2025Key or Button Unresponsive/not Working; Key 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 23879095 ↗
• MalfunctionDec 22, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. 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 23868744 ↗
• MalfunctionDec 22, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE WAKE BUTTON WAS UNRESPONSIVE. 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 23866168 ↗
• MalfunctionDec 22, 2025Key or Button Unresponsive/not Working; Key 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 23865490 ↗