t:slim X2 Insulin Pump with Basal-IQ 1006375Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,016 adverse event reports that list this exact device (DI 00850006613717), received between Sep 24, 2020 and Aug 19, 2026 — classified as 144 injuries, 872 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (221 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 1,016 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 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 50322447 ↗
• MalfunctionJul 8, 2026Pumping Stopped

  IT WAS REPORTED THAT ONGOING CARTRIDGE ALARMS OCCURRED DURING INSULIN DELIVERY. THE CUSTOMER DID NOT HAVE AN ALTERNATE METHOD OF INSULIN THERAPY AVAILABLE. REPORTEDLY, THE CUSTOMER WOULD REACH OUT TO THEIR HCP TO OBTAIN A BACKUP 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 25750216 ↗
• InjuryMay 22, 2026Use of Device Problem

  IT WAS REPORTED THAT THE CUSTOMER ALLOWED THE PUMP BATTERY TO FULLY DEPLETE DUE TO NOT CHARGING THE BATTERY AND THE PUMP SUBSEQUENTLY SHUT OFF ON (B)(6) 2026. CUSTOMER CONTINUED WEARING THE PUMP WITHOUT RESUMING INSULIN THERAPY AND AS A RESULT, EXPERIENCED AN ELEVATED BLOOD GLUCOSE (BG) LEVEL OF 800 MG/DL, ACCOMPANIED BY A KETONE LEVEL THAT WAS IDENTIFIED AS LIFE THREATENING BY THE HEALTHCARE PROVIDER. THE CUSTOMER WAS ADMITTED INTO THE INTENSIVE CARE UNIT (ICU) ON (B)(6) 2026 WHERE THEY WERE TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN. TREATMENT RESOLVED THE ISSUE WITH NO PERMANENT DAMAGE TO THE CUSTOMER AND CUSTOMER WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2026. REPORTEDLY, THE CUSTOMER CONTINUED USING THE PUMP FOR INSULIN THERAPY.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 25260954 ↗
• MalfunctionMay 20, 2026Failure to Charge

  IT WAS REPORTED THAT T:SLIM X2 PUMP BATTERY WOULD NOT CHARGE AND A POWER SOURCE ALERT APPEARED ON PUMP. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. WHILE TROUBLESHOOTING, ISSUE RESOLVED ON ITS OWN AS BATTERY CHARGE INCREASED FROM 5% TO 100%, AND TECHNICAL SUPPORT EXPLAINED CAUSE OF POWER SOURCE ALERT, WHICH CALLER UNDERSTOOD, SO NO FURTHER ACTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25229658 ↗
• MalfunctionMay 14, 2026Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT PUMPS WAKE BUTTON DID NOT FUNCTION AS EXPECTED AND REQUIRED EXTREME EFFORT OR MULTIPLE PRESSES TO TURN ON PUMP SCREEN. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED FURTHER TROUBLESHOOTING FROM TANDEM TECHNICAL SUPPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25173987 ↗
• MalfunctionMay 13, 2026Fracture

  IT WAS REPORTED THAT PUMP TOUCHSCREEN WAS CRACKED AND SHATTERED AFTER PUMP WAS DROPPED AND HIT GROUND, ALTHOUGH CUSTOMER WAS STILL ABLE TO INTERACT WITH PUMP. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER PLANNED TO CONTINUE USING CURRENT PUMP AND RELY ON ALTERNATE METHOD IF NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25159320 ↗
• MalfunctionMay 7, 2026Mechanical Problem

  IT WAS REPORTED THAT PUMP DISPLAYED CARTRIDGE CHANGE ERROR AND CUSTOMER WAS UNABLE TO SUCCESSFULLY LOAD CARTRIDGE ONTO PUMP. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER SUPPORT INSTRUCTED CALLER TO REMOVE CARTRIDGE, INSPECT AND REPLACE DAMAGED O-RING, CLEAN PNEUMATIC TAP AREA, REFILL AND REATTACH NEW CARTRIDGE, AND FOLLOW PUMP INSTRUCTIONS, BUT CARTRIDGE STILL DID NOT LOAD SUCCESSFULLY, SO CASE WAS ESCALATED FOR FURTHER TROUBLESHOOTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25114142 ↗
• MalfunctionApr 16, 2026Pumping Stopped

  IT WAS REPORTED THAT PUMP ISSUED REPEATED CARTRIDGE ALARM 20 WITH CONSECUTIVE CARTRIDGES, AND CALLER REQUESTED REPLACEMENT SUPPLIES AFTER UNSUCCESSFULLY CHANGING CARTRIDGES AND INFUSION SETS TO RESOLVE ISSUE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER PLANNED TO USE MULTIPLE DAILY INJECTIONS AS BACKUP INSULIN THERAPY, AND TECHNICAL SUPPORT ARRANGED SHIPMENT OF REPLACEMENT PUMP, CARTRIDGES, AND INFUSION SETS, PROVIDED INSTRUCTIONS FOR STORING AND RETURNING PROBLEMATIC PUMP WITHIN 10 DAYS, AND ADVISED CUSTOMER TO PROGRAM PUMP SETTINGS AND RECONNECT CONTINUOUS GLUCOSE MONITOR UPON RECEIVING REPLACEMENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899398 ↗
• MalfunctionApr 9, 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 24835058 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER'S BG VALUE DISPLAYED AS "LOW"; HOWEVER, SPECIFIC VALUE WAS NOT PROVIDED. CAUSE OF LOW BG WAS UNKNOWN. REPORTEDLY, CUSTOMER LOST CONSCIOUSNESS AND HAD ASSISTANCE FROM SPOUSE WHO WOKE UP CUSTOMER AND PROVIDED CARBOHYDRATES TO ADDRESS BG. RECOMMENDATION WAS MADE TO CONSULT WITH A HEALTHCARE PROVIDER TO DISCUSS DIABETES MANAGEMENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 24752731 ↗
• MalfunctionMar 31, 2026Pumping Stopped; Charging Problem; Material Twisted/Bent

  IT WAS REPORTED THAT THE PUMP'S USB PORT WAS BENT RESULTING IN DIFFICULTIES CHARGING THE PUMP, RESULTING IN THE PUMP SHUTTING DOWN. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24748592 ↗
• MalfunctionMar 20, 2026Charging Problem; Material Twisted/Bent

  IT WAS REPORTED THAT THE PUMP'S USB PORT WAS BENT RESULTING IN DIFFICULTIES CHARGING THE PUMP. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24654216 ↗
• MalfunctionMar 20, 2026Charging Problem

  IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO CHARGE THE PUMP DUE TO DAMAGE TO THE TANDEM-PROVIDED USB CHARGING CABLE. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. A NEW CHARGING CABLE WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651826 ↗
• MalfunctionMar 16, 2026Obstruction of Flow

  IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER REPLACED SUPPLIES AS NECESSARY AND RESUMED INSULIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24611662 ↗
• MalfunctionMar 11, 2026Incorrect Measurement

  IT WAS REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 300 UNITS OF INSULIN DURING THE LOAD SEQUENCE. A NEW CARTRIDGE WAS LOADED 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 24575780 ↗
• InjuryMar 6, 2026Obstruction of Flow

  IT WAS REPORTED THAT ONGOING INTERMITTENT OCCLUSION ALARMS OCCURRED. THE CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS DISPLAYED AS ¿HIGH¿; HOWEVER, A SPECIFIC VALUE WAS NOT PROVIDED. A MANUAL INSULIN INJECTION WAS ADMINISTERED TO ADDRESS BG LEVEL. CUSTOMER CHANGED CARTRIDGE AND INFUSION SET TO ADDRESS THE ISSUE.

  Patient problems: Hyperglycemia

  MAUDE report 24537170 ↗
• MalfunctionMar 6, 2026Obstruction of Flow

  IT WAS REPORTED THAT ONGOING INTERMITTENT 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 24536579 ↗
• MalfunctionMar 6, 2026Obstruction of Flow

  IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED. A SYSTEM CHECK WAS PERFORMED BY TANDEM TECHNICAL SUPPORT AND THE OCCLUSION WAS FOUND TO BE WITHIN THE CARTRIDGE. CUSTOMER WILL CHANGE THE NECESSARY SUPPLIES TO RESOLVE THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS 361 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536556 ↗
• MalfunctionMar 6, 2026Obstruction of Flow

  IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER WAS USING COLD INSULIN. TANDEM CUSTOMER TECHNICAL SUPPORT INFORMED CUSTOMER THAT INSULIN SHOULD BE AT ROOM TEMPERATURE BEFORE FILLING A CARTRIDGE. CUSTOMER RESOLVED THE ISSUE BY CHANGING THE INFUSION SET AND CARTRIDGE AND RESUMED INSULIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531083 ↗
• MalfunctionMar 5, 2026False Alarm

  IT WAS REPORTED THAT AN ALTITUDE ALARM OCCURRED. REPORTEDLY, THE PUMP WAS NOT OUTSIDE THE LABELED ALTITUDE OPERATING RANGE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY A NEW CARTRIDGE WAS LOADED, AND INSULIN DELIVERY WAS RESUMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521998 ↗
• MalfunctionMar 5, 2026Priming Problem

  THE CALLER REPORTED NOT SEEING DROPS OF INSULIN AT THE END OF THE TUBING DURING THE FILL TUBING STEP OF THE LOAD SEQUENCE, AND THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER REVERTED TO ALTERNATE METHOD OF INSULIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520863 ↗
• MalfunctionFeb 12, 2026Pumping Stopped

  A CALLER REPORTED A MALFUNCTION ON THE PUMP. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER REVERTED TO MULTIPLE DAILY INJECTIONS (MDI) AS A BACKUP INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24326371 ↗
• MalfunctionJan 30, 2026Key or Button Unresponsive/not Working

  THE CUSTOMER REPORTED AN ISSUE WITH THE PUMP'S QUICK BOLUS/WAKE BUTTON, WHICH WAS DIFFICULT TO PRESS AND REQUIRED MULTIPLE ATTEMPTS TO ACTIVATE THE PUMP SCREEN. THERE WAS NO ADVERSE IMPACT ON 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 24220163 ↗
• MalfunctionJan 27, 2026Premature Discharge of Battery

  CUSTOMER REPORTED THAT THE PUMP REQUIRED CHARGING EVERY THREE DAYS. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CALLER DECLINED ADDITIONAL TROUBLESHOOTING, AND THE ISSUE WAS DOCUMENTED WITH THE CASE SUBSEQUENTLY CLOSED WITHOUT FURTHER ACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189555 ↗
• MalfunctionJan 26, 2026Pumping Stopped

  CALLER REPORTED A CARTRIDGE ALARM, SPECIFICALLY ALARM 20, BUT CONFIRMED THE ISSUE DID NOT LEAD TO AN ADVERSE IMPACT ON THE CUSTOMER'S BLOOD GLUCOSE LEVEL. ALTHOUGH THE ALARM WAS NOT LINKED TO THE LOAD PROCESS, IT WAS NOTED THAT THE CALLER EXPERIENCED CARTRIDGE ALARMS WITH CONSECUTIVE CARTRIDGES. TECHNICAL SUPPORT CONFIRMED THIS AND DECIDED TO REPLACE THE PUMP. THE PUMP IN QUESTION WAS OUT OF WARRANTY, YET THE CALLER EXPRESSED INTEREST IN OBTAINING AN OUT-OF-WARRANTY LOANER PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179262 ↗