t:slim X2 Insulin Pump with Basal-IQ 1006377Recalls & reported problems

Summary

The FDA's MAUDE database contains 520 adverse event reports that list this exact device (DI 00850006613724), received between Sep 9, 2020 and Jun 25, 2026 — classified as 39 injuries, 481 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (120 reports).

1 FDA recall record name this device's 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, 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 520 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Break; Charging Problem

  IT WAS REPORTED THAT THE PUMP USB PORT WAS DAMAGED, 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 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 25621992 ↗
• MalfunctionJun 23, 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 25600357 ↗
• MalfunctionMay 4, 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 25074542 ↗
• MalfunctionOct 23, 2025Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT A PUMP MALFUNCTION OCCURRED. 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 23375810 ↗
• MalfunctionOct 21, 2025Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT A MALFUNCTION OCCURRED ON THE CUSTOMER'S PUMP. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT ASSISTED THE CUSTOMER WITH RESETTING THE PUMP, AND THE CUSTOMER WAS INSTRUCTED TO CONTINUE USING THE PUMP WHILE MONITORING FOR ANY RECURRING ISSUES. THE CUSTOMER ACKNOWLEDGED THIS GUIDANCE AND AGREED TO CALL BACK IF THE MALFUNCTION RECURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348052 ↗
• MalfunctionSep 10, 2025Premature Discharge of Battery; Pumping Stopped; Premature Discharge of Battery; Pumping Stopped

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY RESULTING IN THE PUMP SHUTTING DOWN. 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 23017539 ↗
• MalfunctionAug 27, 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 FURTHER TROUBLESHOOTING, AND NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE OUTCOME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22907354 ↗
• MalfunctionJul 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CARTRIDGE WAS LEAKING FROM THE SEPTUM. THERE WAS NO REPORTED ADVERSE EFFECT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT INITIATED A RETURN FOR THE FAULTY CARTRIDGE, WHILE THE CALLER DECLINED ADDITIONAL ASSISTANCE WITH LOADING A NEW CARTRIDGE, INDICATING THEY COULD MANAGE ON THEIR OWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569162 ↗
• MalfunctionJul 8, 2025Pumping Stopped; Pumping Stopped

  A MALFUNCTION WAS REPORTED ON THE PUMP, SHOWING A MALFUNCTION CODE 12. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL, AS IT DID NOT EXCEED 500 MG/DL. TECHNICAL SUPPORT ASSISTED THE CALLER IN RESETTING THE PUMP AND PROVIDED INSTRUCTIONS ON WHAT TO DO IF THE ISSUE RECURRED. THE CUSTOMER WAS ABLE TO CONTINUE USING THE PUMP AND WAS ADVISED TO CALL BACK IF THE MALFUNCTION REAPPEARED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438386 ↗
• MalfunctionJul 3, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT MINIMUM FILL NOTIFICATIONS OCCURRED AFTER THE USER FILLED THE CARTRIDGES WITH (B)(4) UNITS OF INSULIN DURING THE LOAD SEQUENCE. A NEW CARTRIDGE WAS LOADED 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 22396595 ↗
• MalfunctionJun 6, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE WAKE BUTTON WAS UNRESPONSIVE. PUMP DISPLAY TURNED ON WHEN PLUGGED INTO A POWER SOURCE. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22159402 ↗
• MalfunctionJun 4, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE WAKE BUTTON 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 22145810 ↗
• MalfunctionMay 27, 2025Filling Problem; Incorrect Measurement; Filling Problem; Incorrect Measurement

  IT WAS REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 250 UNITS OF INSULIN DURING THE LOAD SEQUENCE. A NEW CARTRIDGE WAS LOADED TO RESOLVE THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 409 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22092788 ↗
• MalfunctionMay 15, 2025Incorrect Measurement; Charging Problem; Incorrect Measurement; Charging Problem

  IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING. ADDITIONALLY, THE CUSTOMER HAD DIFFICULTY CHARGING THE PUMP BATTERY. THERE WAS NO ADVERSE IMPACT TO 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 22028236 ↗
• MalfunctionMar 24, 2025Battery Problem; Charging Problem; Battery Problem; Charging Problem

  IT WAS REPORTED THAT THE PUMP BATTERY WAS "NOT HOLDING A CHARGE AND WILL NOT CHARGE ABOVE 85 PERCENT." 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 21683550 ↗
• MalfunctionMar 3, 2025Pumping Stopped; Battery Problem; Pumping Stopped; Battery Problem

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY RESULTING IN THE PUMP SHUTTING OFF. THERE WAS NO REPORTED ADVERSE IMPACT 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 21505797 ↗
• MalfunctionFeb 19, 2025Incorrect Measurement; Battery Problem; Incorrect Measurement; Battery Problem

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. ADDITIONALLY, IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING. 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 21417300 ↗
• MalfunctionJan 13, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE PUMP BATTERY WAS UNRESPONSIVE. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. THERE WAS NO ADVERSE IMPACT TO CUSTOMER'S BLOOD GLUCOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21144277 ↗
• MalfunctionJan 13, 2025Filling Problem; Incorrect Measurement; Filling Problem; Incorrect Measurement

  IT WAS REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED FOLLOW-UP TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THEREFORE NO ADDITIONAL INFORMATION COULD BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21138521 ↗
• MalfunctionDec 12, 2024Obstruction of Flow; Battery Problem; Device Sensing Problem; Obstruction of Flow; Battery Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY, AND THE WAKE BUTTON WAS NOT WORKING. ADDITIONALLY, OCCLUSION ALARMS OCCURRED. 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 20919193 ↗
• MalfunctionDec 11, 2024Loose or Intermittent Connection; Charging Problem; Device Sensing Problem; Loose or Intermittent Connection; Charging Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY, THE WAKE BUTTON WAS STICKING, AND THE WAKE BUTTON WAS NOT WORKING. IT WAS ALSO 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 ADVERSE IMPACT TO 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 20905120 ↗
• MalfunctionNov 26, 2024Charging Problem; Device Sensing Problem; Charging Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE WAKE BUTTON WAS STICKING. ADDITIONALLY, 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 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 20784940 ↗
• MalfunctionNov 19, 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 CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20727027 ↗
• MalfunctionOct 29, 2024Pumping Stopped; Pumping Stopped

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20561223 ↗
• MalfunctionOct 25, 2024Pumping Stopped; Pumping 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 20537615 ↗