t:slim X2 5.0 Insulin Pump 1000911Recalls & reported problems

Summary

The FDA's MAUDE database contains 15,928 adverse event reports that list this exact device (DI 00853052007318), received between Jul 6, 2018 and Sep 28, 2026 — classified as 2 deaths, 1,623 injuries, 14,303 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (3,109 reports).

2 FDA recall records name this device's identifier, 2 still open.

1 other recall cover devices cleared under the same FDA submission (P140015); they may or may not involve this specific model.

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 ↗

2. 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 15,928 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Obstruction of Flow

  It was reported that pump displayed a recurring occlusion alarm that could not be cleared, and caller stated that pump continued to give occlusion alarms when turned back on after being off in hospital. Reportedly, the customer reverted to an alternate method of insulin therapy. Customer¿s highest blood glucose related to incident was reported in the 400s mg/dL, with ketones, and there was no reported permanent injury. Customer first went to emergency room and was subsequently hospitalized in intensive care, received IV saline and insulin treatment that resolved issue, did not use pump while in hospital because pump was turned off, and CTS was unable to complete further troubleshooting because pump was out of warranty and alarms would not clear, with no further CTS action required. Customer was released from the hospital on (b)(6)2026.

  Patient problems: Hyperglycemia

  MAUDE report 50916779 ↗
• MalfunctionJun 12, 2026Pumping Stopped

  IT WAS REPORTED THAT THE PUMP EXPERIENCED A MALFUNCTION. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER REVERTED TO MULTIPLE DAILY INJECTIONS (MDI) FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25488272 ↗
• MalfunctionApr 27, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT CUSTOMER EXPERIENCED PUMP SCREEN THAT STAYED DARK AND WOULD NOT TURN ON WHILE ATTEMPTING TO USE BACKUP PUMP DURING ONGOING REPLACEMENT PROCESS FOR PRIMARY PUMP MALFUNCTION. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER FOLLOWED TECHNICAL SUPPORT INSTRUCTIONS TO ATTEMPT MULTIPLE BUTTON PRESSES, CONNECT PUMP TO KNOWN WORKING POWER SOURCE, AND WAIT FOR BOOTUP SEQUENCE, BUT PUMP STILL DID NOT POWER ON, SO CUSTOMER PLANNED TO USE MULTIPLE DAILY INJECTIONS AS BACKUP INSULIN THERAPY AND WAS ALREADY IN PROCESS OF RECEIVING REPLACEMENT PUMP, MAKING LOANER PUMP UNNECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001517 ↗
• MalfunctionMar 31, 2026Pumping Stopped

  IT WAS REPORTED THAT INTERMITTENT UNSPECIFIED MALFUNCTION ALARMS OCCURRED. 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 24741766 ↗
• MalfunctionMar 24, 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 24675505 ↗
• MalfunctionMar 4, 2026Mechanical Problem

  A CALLER REPORTED EXPERIENCING A CARTRIDGE ALARM 30 DURING THE LOAD PROCESS WHILE USING THEIR INSULIN PUMP. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. ALTHOUGH THE CUSTOMER FOLLOWED THE CORRECT PROCEDURE DURING THE LOAD PROCESS, THEY COULD NOT SUCCESSFULLY LOAD A CARTRIDGE, AS THE ALARM RECURRED BEFORE CONTACTING TECHNICAL SUPPORT. CONSEQUENTLY, TECHNICAL SUPPORT DECIDED TO REPLACE THE PUMP, AND THE CUSTOMER WOULD USE MULTIPLE DAILY INJECTIONS (MDI) AS A BACKUP THERAPY TO ENSURE CONTINUOUS INSULIN DELIVERY. SINCE THE PUMP WAS OUT OF WARRANTY, A LOANER PUMP WAS ALSO DISCUSSED WITH THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512047 ↗
• MalfunctionFeb 12, 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 24327064 ↗
• MalfunctionFeb 9, 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 24293712 ↗
• MalfunctionFeb 5, 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 24273029 ↗
• InjuryJan 20, 2026Incorrect Measurement; Pumping Stopped

  IT WAS REPORTED THAT THE PUMP'S SCREEN UNEXPECTEDLY WENT BLANK AND THE LED WAS NOT BLINKING. THE CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS DISPLAYED AS ¿HIGH¿; HOWEVER, A SPECIFIC VALUE WAS NOT PROVIDED. THE CUSTOMER ADDRESSED THE HIGH BLOOD GLUCOSE BY ADMINISTERING A BOLUS VIA THE PUMP WITHOUT REQUIRING ASSISTANCE FROM A THIRD PARTY. TECHNICAL SUPPORT EXPLAINED THAT THE SHUTDOWN WAS DUE TO A FUEL GAUGE FLUCTUATION ISSUE AND INSTRUCTED THE CUSTOMER ON RESETTING PROCEDURES FOR THE PUMP. FURTHERMORE, THE CUSTOMER WAS INFORMED THAT THIS ISSUE HAS BEEN RESOLVED IN A SOFTWARE UPDATE, AND THEY ACKNOWLEDGED THE INFORMATION PROVIDED.

  Patient problems: Hyperglycemia

  MAUDE report 24117755 ↗
• MalfunctionJan 14, 2026Unexpected Shutdown

  IT WAS REPORTED THAT THE PUMP SHUT DOWN UNEXPECTEDLY. THERE WAS NO PATIENT INVOLVEMENT, AS THE PUMP WAS BEING USED FOR DEMONSTRATION PURPOSES ONLY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24073198 ↗
• MalfunctionJan 12, 2026Failure to Charge

  IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. 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 24037878 ↗
• MalfunctionDec 26, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED ASSISTANCE FROM TANDEM TECHNICAL SUPPORT REGARDING THE ISSUES. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23900977 ↗
• MalfunctionDec 19, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. THERE WAS NO REPORTED ADVERSE 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 23856019 ↗
• MalfunctionDec 16, 2025Premature Discharge of Battery; Premature 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 ASSISTANCE FROM TANDEM TECHNICAL SUPPORT REGARDING THE ISSUES. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23823101 ↗
• MalfunctionDec 9, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE PUMP TOUCHSCREEN WAS TIMING OFF SOONER THAN EXPECTED INTERMITTENTLY. 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 23763877 ↗
• MalfunctionDec 9, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE WAKE BUTTON ON THE PUMP WAS DELAYED IN RESPONDING TO TOUCH, REQUIRING THE CUSTOMER TO PRESS ON THE BUTTON WITH EXTRA FORCE BEFORE THE PUMP RESPONDS TO TURNING THE SCREEN ON. 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 23763823 ↗
• MalfunctionDec 9, 2025Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. 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 23762683 ↗
• MalfunctionNov 21, 2025Pumping Stopped; Pumping Stopped

  A MALFUNCTION ON THE PUMP WAS REPORTED BY THE CUSTOMER. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT ASSISTED THE CUSTOMER BY PROVIDING INSTRUCTIONS FOR RESETTING THE PUMP, AFTER WHICH THE MALFUNCTION DID NOT RECUR, ALLOWING THE CUSTOMER TO CONTINUE USING THE PUMP WITH AN UNDERSTANDING TO CALL BACK IF THE ISSUE REAPPEARED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619904 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER REQUIRED ASSISTANCE TO TREAT A PAST LOW BLOOD GLUCOSE LEVEL. CUSTOMER COULD "NOT REMEMBER THE DATE OR DETAILS OF THE HOSPITALIZATION EVENT." REPORTEDLY, THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypoglycemia

  MAUDE report 23582225 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED; DETAILS AND NATURE OF HOSPITALIZATION WERE NOT PROVIDED. MULTIPLE CONTACT ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE ISSUE; HOWEVER, NO RESPONSE WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 23522194 ↗
• MalfunctionNov 10, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED "BATTERY DIMINISHED LIFE, PT WILL CHARGE PUMP AND IT WILL TELL HER IT IS LOW BATTERY AND AS SOON AS SHE PLUGS IT IN PUMP WILL TELL HER IT IS CHARGED MUCH MORE THAN IT ACTUALLY IS. THIS CAUSES PT TO HAVE TO CHARGE PUMP DAILY BECAUSE PT DOES NOT FEEL LIKE PUMP IS RELIABLE." THERE WAS NO REPORTED ADVERSE EFFECT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED ASSISTANCE FROM TANDEM TECHNICAL SUPPORT REGARDING THE ISSUE. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509502 ↗
• MalfunctionNov 4, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. CUSTOMER RELOADED THE 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 23472337 ↗
• MalfunctionSep 17, 2025Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE. 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 23073075 ↗
• MalfunctionSep 15, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING THE LOAD SEQUENCE. REPORTEDLY, THE CUSTOMER CONTACTED THE HEALTHCARE PROVIDER TO OBTAIN ALTERNATE INSULIN THERAPY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23050804 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140015. One submission often covers many models, so check the product and lot details in each record.

• Z-2471-2018 · Apr 23, 2018 · Open, Classified
  t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B.