t:slim X2 Insulin PumpRecalls & reported problems across all models

We found 2 models of t:slim X2 Insulin Pump by Tandem Diabetes Care, Inc. in the FDA's device registry (GUDID). Together they are named in 8,967 adverse event reports in the FDA's MAUDE database, received between Mar 6, 2017 and Oct 20, 2025 — classified as 1 death, 746 injuries, 8,220 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (1,981 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

t:slim X2 Insulin Pump recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 24, 2022Open, 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 · names 2 of these models · Recall details · FDA record ↗

Most reported t:slim X2 Insulin Pump problems

t:slim X2 Insulin Pump models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• t:slim X2 Insulin Pump 1000103

  Pump, Infusion, Insulin
  1 recall1 death7,327 reports
• t:slim X2 Insulin Pump 1000369

  Pump, Infusion, Insulin
  1 recall1,640 reports

Recent t:slim X2 Insulin Pump adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2025Pumping Stopped; Pumping Stopped

  A MALFUNCTION WAS REPORTED ON A CUSTOMER'S PUMP, BUT THERE WAS NO ADVERSE IMPACT ON THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE PUMP WAS NOT UNDER WARRANTY, LEADING THE CUSTOMER TO INQUIRE ABOUT AN OUT-OF-WARRANTY LOANER PUMP. TECHNICAL SUPPORT DECIDED TO REPLACE THE PUMP AND SENT OUT A LOANER UNIT. THE CALLER WAS GUIDED ON USING BACKUP THERAPY TO ENSURE INSULIN DELIVERY WAS NOT INTERRUPTED AND WAS INFORMED ABOUT UPCOMING STEPS UPON RECEIVING THE NEW PUMP. THE CUSTOMER ACKNOWLEDGED AND COMPLETED ALL NECESSARY AGREEMENTS RELATED TO THE LOANER PUMP ARRANGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337428 ↗
• InjuryOct 17, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED ONGOING ISSUES WITH INSULIN DOSAGE. RESULTING IN THE CUSTOMER GOING TO THE EMERGENCY ROOM MULTIPLE TIMES. THE CUSTOMER DECLINED ASSISTANCE FROM TANDEM TECHNICAL SUPPORT REGARDING THE ISSUE. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23331350 ↗
• MalfunctionAug 26, 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 CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897534 ↗
• MalfunctionAug 21, 2025Loose or Intermittent Connection; Charging Problem; Loose or Intermittent Connection; Charging Problem

  IT WAS REPORTED THAT THE PUMP'S USB PORT WAS LOOSE, RESULTING IN DIFFICULTIES CHARGING THE PUMP. 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 22863919 ↗
• MalfunctionAug 8, 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 CONTACT ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE ISSUE; HOWEVER, THE CUSTOMER DID NOT RESPOND. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22748355 ↗
• MalfunctionAug 7, 2025Fracture; Fracture

  CUSTOMER REPORTED A CRACK ON THE SCREEN, WHICH WAS HARD TO SEE AND SOMETIMES UNRESPONSIVE. THERE WAS NO REPORTED IMPACT ON THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED FURTHER TROUBLESHOOTING, AND THE ISSUE WAS DOCUMENTED BY TECHNICAL SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739188 ↗
• MalfunctionAug 7, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE PUMP BATTERY WAS UNRESPONSIVE. 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 22736890 ↗
• MalfunctionAug 6, 2025Failure to Charge; Pumping Stopped; Failure to Charge; Pumping Stopped

  IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED, LEADING TO THE PUMP SHUTTING OFF. 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 22730071 ↗
• MalfunctionAug 5, 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. REPORTEDLY, THE CUSTOMER HAD AN ALTERNATE PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22719360 ↗
• MalfunctionAug 5, 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. REPORTEDLY, THE CUSTOMER HAD AN ALTERNATE PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22719290 ↗
• MalfunctionAug 5, 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. REPORTEDLY, THE PUMP SUCCESSFULLY BEGAN CHARGING AFTER LEAVING THE PUMP PLUGGED INTO THE POWER SOURCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22718825 ↗
• MalfunctionJul 31, 2025Loose or Intermittent Connection; Charging Problem; Loose or Intermittent Connection; Charging Problem

  IT WAS REPORTED THAT THE PUMP'S USB PORT WAS LOOSE, AND THE PUMP BATTERY INTERMITTENTLY COULD NOT BE CHARGED PROPERLY WITHOUT THE CUSTOMER MANEUVERING THE CABLE INTO THE CHARGING PORT AT A CERTAIN ANGLE. 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 22678393 ↗
• MalfunctionJul 29, 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. 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 22650390 ↗
• MalfunctionJul 16, 2025Date/Time-Related Software Problem; Date/Time-Related Software Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521397 ↗
• MalfunctionJul 16, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT AN UNEXPECTED RESET OCCURRED. 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 22519256 ↗

Other Tandem Diabetes Care, Inc. products

• t:slim X2 Insulin Pump45 models · 897,233 reports · 4 recalls
• t:slim X2 Insulin Pump with Control-IQ11 models · 522,176 reports · 2 recalls
• t:slim X2 Insulin Pump with Basal-IQ14 models · 195,037 reports · 2 recalls
• t:slim X2 Insulin Pump with Control-IQ Technology11 models · 126,966 reports · 3 recalls
• Tandem Mobi7 models · 51,239 reports · 3 recalls
• t:slim X2 5.0 Insulin Pump5 models · 41,241 reports · 2 recalls