t:slim X2 5.0 Insulin PumpRecalls & reported problems across all models

We found 5 models of t:slim X2 5.0 Insulin Pump by Tandem Diabetes Care, Inc. in the FDA's device registry (GUDID). Together they are named in 41,241 adverse event reports in the FDA's MAUDE database, received between Jul 6, 2018 and Sep 28, 2026 — classified as 6 deaths, 3,863 injuries, 37,372 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (7,898 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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 5.0 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. Jul 21, 2025Open, 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, 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 5 of these models · Recall details · FDA record ↗

Most reported t:slim X2 5.0 Insulin Pump problems

t:slim X2 5.0 Insulin Pump models

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

• t:slim X2 5.0 Insulin Pump 1000885

  Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
  1 recall2 deaths17,224 reports
• t:slim X2 5.0 Insulin Pump 1000911

  Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
  2 recalls2 deaths15,928 reports
• t:slim X2 5.0 Insulin Pump 1000897

  Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
  1 recall2 deaths6,444 reports
• t:slim X2 5.0 Insulin Pump 1000891

  Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
  1 recall1,561 reports
• t:slim X2 5.0 Insulin Pump 1003487

  Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
  1 recall84 reports

Recent t:slim X2 5.0 Insulin Pump adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• MalfunctionAug 7, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50177473 ↗
• MalfunctionJul 6, 2026Pumping Stopped

  IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. DURING TROUBLESHOOTING WITH TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED, AND INSULIN DELIVERY WAS RESUMED SUCCESSFULLY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25716999 ↗
• 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 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 ↗
• InjuryJun 8, 2026Use of Device Problem

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ELEVATED BLOOD GLUCOSE (BG) LEVEL DISPLAYED AS "HIGH"; HOWEVER, SPECIFIC VALUE WAS NOT PROVIDED. REPORTEDLY THE CUSTOMER DID NOT DELIVER A MEAL BOLUS. A CORRECTION BOLUS WAS DELIVERED TO ADDRESS BG. RECOMMENDATION WAS MADE TO CONSULT WITH A HEALTHCARE PROVIDER REGARDING DIABETES MANAGEMENT.

  Patient problems: Hyperglycemia

  MAUDE report 25429512 ↗
• MalfunctionJun 4, 2026Mechanical Problem

  IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING THE LOAD SEQUENCE. THERE WAS NO 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 25399276 ↗
• 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 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 ↗
• 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 ↗
• MalfunctionApr 9, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT CUSTOMER EXPERIENCED BATTERY DEPLETION ISSUE WITH PUMP. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED FURTHER FOLLOW-UP AND NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE OUTCOME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24837599 ↗

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 Insulin Pump2 models · 8,967 reports · 1 recall