t:slim X2 5.0 Insulin Pump 1000885Recalls & reported problems

Summary

The FDA's MAUDE database contains 17,224 adverse event reports that list this exact device (DI 00853052007257), received between Jul 6, 2018 and Aug 17, 2026 — classified as 2 deaths, 1,251 injuries, 15,971 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (3,553 reports).

1 FDA recall record name this device's identifier, 1 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. 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 17,224 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Incorrect Measurement

  It was reported that the insulin gauge was inaccurate. There was no reported impact to the customer¿s blood glucose level. 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 50280622 ↗
• MalfunctionJun 29, 2026Pumping Stopped

  IT WAS REPORTED THAT ONGOING CARTRIDGE ALARMS OCCURRED DURING INSULIN DELIVERY. CUSTOMER REVERTED TO MULTIPLE DAILY INJECTIONS (MDI) FOR INSULIN THERAPY. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25653731 ↗
• MalfunctionJun 3, 2026Date/Time-Related Software Problem

  IT WAS REPORTED THAT THE PUMP TIME WAS INCORRECT, CAUSE WAS UNKNOWN. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE CUSTOMER CORRECTED THE TIME AND RESUMED INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25376579 ↗
• MalfunctionJun 2, 2026Mechanical 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 25367526 ↗
• MalfunctionMay 6, 2026Incorrect Measurement

  IT WAS REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED WHILE CUSTOMER ATTEMPTED TO LOAD NEW CARTRIDGE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER CLEANED PNEUMATIC TAP AREA AS INSTRUCTED BY TECHNICAL SUPPORT, RELOADED SAME CARTRIDGE WITH USABLE INSULIN, AND SUCCESSFULLY LOADED CARTRIDGE ONTO PUMP AND RESUMED INSULIN DELIVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25101912 ↗
• MalfunctionApr 21, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT PUMP TOUCHSCREEN WAS NOT AS RESPONSIVE AS BEFORE, ALTHOUGH CUSTOMER DID NOT CLARIFY WHETHER SCREEN FAILED TO RESPOND OR RESPONDED WITH DELAY. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER DID NOT PROVIDE ADDITIONAL INFORMATION, DECLINED FOLLOW-UP CONTACT, AND CASE WAS CLOSED WITH NO FURTHER TROUBLESHOOTING OR CORRECTIVE ACTIONS DOCUMENTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24938535 ↗
• MalfunctionApr 20, 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 FROM TANDEM TECHNICAL SUPPORT REGARDING THE ISSUE, THEREFORE NO ADDITIONAL INFORMATION WAS OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927247 ↗
• MalfunctionMar 17, 2026Mechanical Problem

  IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING THE LOAD SEQUENCE. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24623732 ↗
• MalfunctionMar 17, 2026Pumping Stopped

  CUSTOMER REPORTED EXPERIENCING A MALFUNCTION AFTER HE STOPPED USING THE PUMP FOR A FEW MONTHS. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER PLANNED TO LOCATE THE ALTERNATE PUMP AND FOLLOW UP IF ANY ISSUES ARISE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616743 ↗
• MalfunctionMar 11, 2026Pumping Stopped

  IT WAS REPORTED THAT A DEVICE ISSUE OCCURRED WHEN THE CUSTOMER WOKE UP TO A NOTIFICATION THAT NO INSULIN WAS AVAILABLE, DESPITE HAVING COMPLETED A LOAD OPERATION LESS THAN 24 HOURS EARLIER. THE CUSTOMER ATTEMPTED TO RELOAD THE DEVICE AND RESET IT WITHOUT SUCCESS AND SUSPECTED THE POSSIBILITY OF THE DEVICE BEING NON-FUNCTIONAL DUE TO IT BEING OUT OF WARRANTY FOR SOME TIME. THE CUSTOMER NEEDED A NEW DEVICE URGENTLY. CUSTOMER SUPPORT ATTEMPTED TO TROUBLESHOOT THE ISSUE AND FOLLOWED UP WITH THE CUSTOMER BUT WAS UNABLE TO RESOLVE THE ISSUE, ULTIMATELY CLOSING THE CASE AFTER ALL FOLLOW-UP ATTEMPTS WERE EXHAUSTED. THERE WAS NO REPORTED IMPACT ON THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567876 ↗
• MalfunctionFeb 20, 2026Mechanical Problem

  A CUSTOMER REPORTED A CARTRIDGE CHANGE ERROR WITH THEIR INSULIN PUMP. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405817 ↗
• MalfunctionFeb 18, 2026Mechanical Problem

  A CUSTOMER REPORTED A CARTRIDGE CHANGE ERROR WITH THEIR INSULIN PUMP. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL AS IT DID NOT EXCEED CRITICAL LEVELS. INITIALLY, THE CUSTOMER WAS GUIDED BY TECHNICAL SUPPORT TO INSPECT VARIOUS PARTS OF THE PUMP AND ATTEMPT TO LOAD A NEW CARTRIDGE; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. FOLLOWING THESE EFFORTS, A CALLBACK WAS ARRANGED BY THE CUSTOMER SUPPORT TEAM, WHERE THE CUSTOMER EXPRESSED CONTINUED DIFFICULTIES WITH THE SAME ERROR AND A RECENT LOW BLOOD GLUCOSE EPISODE OF 72 MG/DL. DESPITE ATTEMPTS TO RESOLVE THE ERROR, THE ISSUE PERSISTED, LEADING TO THE DECISION TO REPLACE THE PUMP. ALTHOUGH THE PUMP WAS OUT OF WARRANTY, THE CUSTOMER DECLINED THE OPTION FOR AN OUT-OF-WARRANTY LOANER PUMP AND OPTED TO USE MULTIPLE DAILY INJECTIONS (MDI) TO AVOID INTERRUPTIONS IN INSULIN DELIVERY. THE ONGOING ISSUE HAD BEEN REPORTED PREVIOUSLY UNDER DIFFERENT CASES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377400 ↗
• MalfunctionFeb 12, 2026Incorrect Measurement

  IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING. 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 24323798 ↗
• MalfunctionFeb 11, 2026Pumping Stopped

  IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING INSULIN DELIVERY. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24318765 ↗
• MalfunctionFeb 4, 2026Mechanical Problem

  IT WAS REPORTED THAT THE PUMP EXPERIENCED A CARTRIDGE CHANGE ERROR. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER RECEIVED ASSISTANCE FROM TECHNICAL SUPPORT TO REMOVE AND INSPECT THE CARTRIDGE, DISCOVERING THAT THE O-RING WAS NOT IN PLACE, AND TRIED TO LOAD A NEW CARTRIDGE WITHOUT SUCCESS. DESPITE ASSISTANCE TO ADDRESS ISSUES LIKE CLEANING THE PNEUMATIC TAP AREA AND ENSURING THE CARTRIDGE WAS PROPERLY ATTACHED, THE ERROR PERSISTED. FURTHER TROUBLESHOOTING WAS ESCALATED AS PHOTOS REVEALED THE RACK PUSHROD WAS DAMAGED. THE CUSTOMER WAS INFORMED THEY MIGHT NEED TO USE AN ALTERNATIVE METHOD FOR INSULIN DELIVERY WHILE A RESOLUTION WAS SOUGHT. NO ADDITIONAL REPLACEMENT COULD BE PROVIDED DUE TO WARRANTY CONSTRAINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256565 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A BLOOD GLUCOSE (BG) LEVEL OF 420 MG/DL. ELEVATED BG WAS ADDRESSED BY MANUAL INSULIN INJECTION AND CORRECTION BOLUS VIA PUMP. THE CAUSE OF THE ELEVATED BG WAS UNKNOWN. THE CUSTOMER WENT TO THE EMERGENCY ROOM (ER), AND BG WAS TREATED WITH MANUAL INSULIN INJECTIONS. SYSTEM CHECK WITH TANDEM TECHNICAL SUPPORT CONFIRMED THE PUMP WAS FUNCTIONING AS INTENDED. TANDEM TECHNICAL SUPPORT FOLLOWED UP WITH THE CUSTOMER TO OBTAIN A RELEASE DATE FROM THE ER AND THE CUSTOMER WAS NOT ABLE TO PROVIDE THE DATE.

  Patient problems: Hyperglycemia

  MAUDE report 24046182 ↗
• MalfunctionJan 7, 2026Incorrect Measurement

  IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE VALUE. REPORTEDLY, CUSTOMER CONTINUED USING PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23996015 ↗
• MalfunctionDec 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PUMP TOUCHSCREEN WAS CRACKED, CAUSING IT TO BE DELAYED IN RESPONDING TO TOUCH INPUT. 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 23693464 ↗
• MalfunctionNov 29, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. THERE WAS NO REPORTED IMPACT TO 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 23675944 ↗
• MalfunctionNov 26, 2025Break; Charging Problem; Break; Charging Problem

  IT WAS REPORTED THAT THE PUMP'S USB PORT WAS DAMAGED RESULTING IN DIFFICULTIES CHARGING THE PUMP. THERE WAS NO REPORTED ADVERSE IMPACT TO 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 23659246 ↗
• MalfunctionOct 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PUMP WAS NOT WORKING PROPERLY. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. MULTIPLE ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, THE CUSTOMER DID NOT RESPOND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23386156 ↗
• MalfunctionOct 21, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. CUSTOMER RELOADED THE 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 23348868 ↗
• MalfunctionOct 21, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. CUSTOMER RELOADED THE 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 23348861 ↗
• MalfunctionOct 21, 2025Failure to Charge; Failure 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. MULTIPLE FOLLOW UP ATTEMPTS WERE MADE TO COMPLETE TROUBLESHOOTING WITH THE CUSTOMER; HOWEVER, THE CUSTOMER DID NOT RESPOND TO FOLLOW UP ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348852 ↗
• MalfunctionOct 21, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE PUMP SHUT OFF UNEXPECTEDLY. THERE WAS NO REPORTED IMPACT TO 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 23347226 ↗

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.