t:slim X2 5.0 Insulin Pump 1000897Recalls & reported problems

Summary

The FDA's MAUDE database contains 6,444 adverse event reports that list this exact device (DI 00853052007295), received between Jul 9, 2018 and Jun 8, 2026 — classified as 2 deaths, 857 injuries, 5,585 malfunctions.

The most frequently reported specific device problem is “Charging Problem” (1,064 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 6,444 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMar 20, 2026Pumping Stopped

  CALLER REPORTED A MALFUNCTION ON THE PUMP, SPECIFICALLY IDENTIFIED AS MALF 0, WITH A FAULT ID OF 9-0X20F1. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT PROVIDED PUMP RESET INFORMATION AND ASSISTED THE CALLER IN RESETTING THE PUMP, AFTER WHICH THE MALFUNCTION CODE DID NOT RECUR. CALLER WAS ADVISED TO CONTINUE USING THE PUMP AND TO CALL BACK IF THE ISSUE ARISES AGAIN, WHICH THEY ACKNOWLEDGED AND UNDERSTOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24648203 ↗
• MalfunctionMar 9, 2026Data Problem

  IT WAS REPORTED THAT THE PUMP INDICATED A DATA LOG CORRUPTION. THERE WAS NO ADVERSE IMPACT ON 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 24544124 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CONTROL-IQ ALGORITHM SUSPENDED BASAL DELIVERY IN RESPONSE TO THE CONTINUOUS GLUCOSE MONITOR (CGM) SENSOR READING; HOWEVER, THE CGM SENSOR READING WAS INACCURATE. REPORTEDLY, THE CGM BLOOD GLUCOSE (BG) READING WAS A LEVEL THAT WAS DISPLAYED AS ¿LOW¿; HOWEVER, A SPECIFIC VALUE WAS NOT PROVIDED, AND THE CONTACT WAS UNABLE TO PROVIDE A METER BG READING AT THE TIME OF THE EVENT. AS A RESULT OF THE BASAL SUSPENSION AND CUSTOMER TREATING A FALSE LOW, CUSTOMER'S BLOOD GLUCOSE (BG) ROSE AND EXPERIENCED DIABETIC KETOSIS. HIGHEST BG LEVEL WAS NOT PROVIDED AT TIME OF THE EVENT. DUE TO THE ELEVATED BG LEVEL THE CUSTOMER LOSS CONSCIOUSNESS. CUSTOMER WENT TO THE EMERGENCY ROOM (ER) AND WAS ADMITTED INTO THE INTENSIVE CARE UNIT. CUSTOMER WAS TREATED WITH INTRAVENOUS FLUIDS OF INSULIN AND SALINE AND WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2025. 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: Hyperglycemia; Loss of consciousness

  MAUDE report 24511858 ↗
• MalfunctionNov 17, 2025Pumping Stopped; Pumping Stopped

  A MALFUNCTION WAS REPORTED ON THE PUMP. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL, AS IT DID NOT EXCEED 500 MG/DL. THE CUSTOMER RECEIVED INFORMATION ON HOW TO RESET THE PUMP FROM TECHNICAL SUPPORT, SUCCESSFULLY RESET THE DEVICE, AND CONFIRMED THAT THE MALFUNCTION DID NOT RECUR. THE CUSTOMER WAS ADVISED TO CONTINUE USING THE PUMP AND TO CONTACT TECHNICAL SUPPORT IF THE ISSUE RECURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23575806 ↗
• MalfunctionOct 30, 2025Pumping Stopped; Pumping Stopped

  A CALLER REPORTED A MALFUNCTION ON THE PUMP, IDENTIFIED BY MALFUNCTION CODE MALF 9, WHICH WAS RESETTABLE. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT PROVIDED INFORMATION ON RESETTING THE PUMP AND ASSISTED THE CALLER WITH THE PROCESS, ENSURING THE MALFUNCTION CODE DID NOT RECUR. THE CUSTOMER WAS ADVISED TO CONTINUE USING THE PUMP AND INSTRUCTED TO CALL BACK IF ANY MALFUNCTION CODE RECURS, WHICH THE CALLER ACKNOWLEDGED AND UNDERSTOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23429604 ↗
• MalfunctionJul 8, 2025Charging Problem; Material Twisted/Bent; Charging Problem; Material Twisted/Bent

  IT WAS REPORTED THAT THE PUMP'S USB PORT WAS BENT RESULTING IN DIFFICULTIES CHARGING THE PUMP. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440961 ↗
• MalfunctionJul 8, 2025False Alarm; False Alarm

  AN ALTITUDE ALARM WAS REPORTED FOR A PUMP, CAUSING THE CUSTOMER'S INSULIN TO BE SUSPENDED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL DID NOT EXCEED 500 MG/DL, INDICATING THERE WAS NO ADVERSE IMPACT. TECHNICAL SUPPORT ADVISED THE CUSTOMER TO CLEAN THE SPEAKER HOLES AND ATTEMPT CARTRIDGE RECONNECTION, BUT INSULIN DELIVERY COULD NOT BE RESUMED IMMEDIATELY. EVENTUALLY, THE CUSTOMER WAS INSTRUCTED TO LOAD A NEW CARTRIDGE AND RESUME INSULIN DELIVERY, BUT THE ALARM PERSISTED. AN ATTEMPT WAS 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 22437132 ↗
• MalfunctionJun 30, 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. THE CUSTOMER DECLINED FOLLOW UP WITH TANDEM TECHNICAL SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22366641 ↗
• MalfunctionJun 26, 2025Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE PUMP WAS NOT HOLDING A CHARGE WELL, REQUIRING CHARGING EVERY TWO DAYS, THE SLIDE FOR INSERTING THE CARTRIDGE WAS DEGRADING, AND THE SCREEN HAD SCRATCHES. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED FURTHER TROUBLESHOOTING AND DID NOT SEEK ADDITIONAL FOLLOW-UP OR ASSISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22335524 ↗
• MalfunctionJun 10, 2025Measurement System Incompatibility; Measurement System Incompatibility

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A POWER SOURCE ALERT WHILE USING THE TANDEM-PROVIDED USB CABLE AND WALL ADAPTER. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE CUSTOMER WAS ABLE TO SUCCESSFULLY CHARGE THE PUMP USING AN ALTERNATE WALL ADAPTER AND USB CABLE. THERE WAS NO ADVERSE IMPACT THE CUSTOMER¿S BLOOD GLUCOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177415 ↗
• MalfunctionMay 29, 2025Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22108427 ↗
• InjuryMar 14, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED OCCLUSION ALARMS OCCURRED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS DISPLAYED AS "HIGH"; A SPECIFIC VALUE WAS NOT PROVIDED. ELEVATED BLOOD GLUCOSE WAS ADDRESSED WITH A MANUAL DOSE INJECTION. THE CUSTOMER CHANGED SUPPLIES AND RESUMED INSULIN THERAPY.

  Patient problems: Hyperglycemia

  MAUDE report 21606058 ↗
• MalfunctionMar 11, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. THERE WAS NO REPORTED ADVERSE IMPACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21573707 ↗
• MalfunctionJan 24, 2025Pumping Stopped; Pumping 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 21231005 ↗
• InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A BLOOD GLUCOSE (BG) LEVEL THAT DISPLAYED AS "HIGH", SPECIFIC VALUE NOT PROVIDED. CAUSE OF BG LEVEL WAS NOT KNOWN. CUSTOMER ADMINISTERED A BOLUS OF INSULIN VIA THE PUMP AND A MANUAL INJECTION TO ADDRESS THE ISSUE AND WENT TO THE EMERGENCY ROOM. CUSTOMER WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND WAS NOT SURE IF THEY WERE GIVEN INSULIN. CUSTOMER WAS DISCHARGED THE SAME DAY WITHOUT THE ISSUE RESOLVED AND NO PERMANENT DAMAGE. TANDEM TECHNICAL SUPPORT DID A FULL PUMP SYSTEM CHECK AND CONFIRMED THAT PUMP WAS FUNCTIONING AS INTENDED.

  Patient problems: Hyperglycemia

  MAUDE report 21219745 ↗
• MalfunctionJan 2, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE WAKE BUTTON WAS LESS RESPONSIVE. 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 21056964 ↗
• MalfunctionDec 13, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING THE LOAD PHASE. THE CUSTOMER REVERTED TO AN ALTERNATE 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 20926164 ↗
• MalfunctionDec 6, 2024Incorrect Measurement; Pumping Stopped; Incorrect Measurement; Pumping Stopped

  IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP INTERMITTENTLY SHUT OFF UNEXPECTEDLY. 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 20864616 ↗
• MalfunctionNov 18, 2024Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. THE CUSTOMER REVERTED TO AN ALTERNATE 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 20707103 ↗
• MalfunctionNov 13, 2024Date/Time-Related Software Problem; Date/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. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20676197 ↗
• MalfunctionNov 6, 2024Battery Problem; Battery Problem

  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 20620535 ↗
• MalfunctionOct 16, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. 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 20460701 ↗
• MalfunctionSep 18, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A CONTINUOUS GLUCOSE MONITOR ERROR 42. THE PUMP WAS RESET, AND THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246386 ↗
• MalfunctionSep 6, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. 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 20164285 ↗

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.