t:slim Insulin Pump 007435Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,104 adverse event reports that list this exact device (DI 00852162004361), received between Nov 8, 2018 and Sep 16, 2025 — classified as 7 deaths, 239 injuries, 1,858 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (423 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 2,104 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED SINCE 2016 THE CUSTOMER INTERMITTENTLY HAS REQUIRED ASSISTANCE TO TREAT BLOOD GLUCOSE (BG) LEVELS. IT WAS NOT PROVIDED IF BG LEVEL WAS LOW OR HIGH. CUSTOMER WAS ADMITTED INTO THE INTENSIVE CARE UNIT AND WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE. CUSTOMER WAS RELEASED FROM THE HOSPITAL WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE; HOWEVER, DOES NOT RECALL RELEASE DATES. TANDEM TECHNICAL SUPPORT (CTS) PERFORMED A SYSTEM CHECK AND DETERMINED THAT THE PUMP FUNCTIONED AS INTENDED AND THE CAUSE WAS UNKNOWN. CUSTOMER ACKNOWLEDGED THAT THE PUMP WAS FUNCTIONING AS INTENDED AND CONTINUED TO USE PUMP FOR INSULIN THERAPY.

  Patient problems: Insufficient Information

  MAUDE report 23064821 ↗
• MalfunctionApr 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PUMP WAS NOT WORKING PROPERLY. 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 21751970 ↗
• MalfunctionJan 27, 2025Data Problem; Data Problem

  IT WAS REPORTED THAT THE PUMP INDICATED A DATA LOG CORRUPTION. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS APPROXIMATELY 100 MG/DL. REPORTEDLY, CUSTOMER CONTINUED USING PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21243005 ↗
• MalfunctionJan 13, 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 21146004 ↗
• MalfunctionJan 2, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE PUMP BATTERY WAS UNRESPONSIVE. THERE WAS NO ADVERSE IMPACT TO CUSTOMER'S BLOOD GLUCOSE. NO ADDITIONAL INFORMATION WAS PROVIDED AND THE CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21063917 ↗
• MalfunctionOct 22, 2024Pumping Stopped; Failure to Sense; Battery Problem; Pumping Stopped; Failure to Sense; Battery Problem

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE AND THAT THE PUMP SHUT OFF UNEXPECTEDLY. 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 20506453 ↗
• InjuryOct 14, 2024Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT AIR BUBBLES WERE OBSERVED WITHIN THE INFUSION SET TUBING. CUSTOMER'S CONTINUOUS GLUCOSE MONITOR READ "HIGH", HOWEVER, SPECIFIC BLOOD GLUCOSE (BG) VALUE WAS NOT PROVIDED. A CORRECTION BOLUS VIA THE PUMP WAS DELIVERED TO ADDRESS BG. 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: Hyperglycemia

  MAUDE report 20447758 ↗
• MalfunctionOct 6, 2024Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE PUMP BATTERY WAS NOT CHARGING. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED FOLLOW UP WITH TANDEM CUSTOMER TECHNICAL SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20380319 ↗
• MalfunctionSep 25, 2024Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY. 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 20301840 ↗
• MalfunctionSep 20, 2024Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE WAKE BUTTON WAS STICKING. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. NO ADDITIONAL INFORMATION WAS PROVIDED. CUSTOMER DECLINED FOLLOW UP FROM TANDEM TECHNICAL SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20271306 ↗
• MalfunctionSep 3, 2024Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. 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 20125839 ↗
• MalfunctionAug 6, 2024Incorrect 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. 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 19919431 ↗
• MalfunctionJul 3, 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 19666254 ↗
• MalfunctionJun 14, 2024Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. 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 19537632 ↗
• MalfunctionJun 11, 2024Pumping Stopped; Fitting Problem; Pumping Stopped; Fitting Problem

  IT WAS REPORTED THAT A CARTRIDGE WAS LOOSE ON THE PUMP. A CARTRIDGE CHANGE WAS PERFORMED RESOLVING THE ISSUE. ADDITIONALLY, 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 REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19510571 ↗
• MalfunctionJun 5, 2024Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT AN UNSPECIFIED MALFUNCTION ALARM OCCURRED. 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 19471404 ↗
• MalfunctionMay 10, 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 19288998 ↗
• MalfunctionApr 12, 2024Incorrect Measurement; Pumping Stopped; Incorrect Measurement; Pumping Stopped

  IT WAS REPORTED THAT THE PUMP SHUT OFF UNEXPECTEDLY AND THE INSULIN GAUGE WAS INACCURATE. 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 19096720 ↗
• MalfunctionApr 3, 2024Device 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, CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19033211 ↗
• MalfunctionMar 8, 2024Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT AN UNSPECIFIED 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 18865873 ↗
• MalfunctionMar 4, 2024Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A POWER SOURCE ALERT AFTER PLUGGING THE PUMP INTO A WALL OUTLET WITH A NON-TANDEM WALL ADAPTER AND CABLE. REPORTEDLY, THE ALERT CLEARED, AND THE PUMP SUCCESSFULLY BEGAN CHARGING AFTER LEAVING THE PUMP PLUGGED INTO THE POWER SOURCE. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18830144 ↗
• MalfunctionFeb 28, 2024Failure to Sense; Battery Problem; Device Sensing Problem; Failure to Sense; Battery Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE AND THE WAKE BUTTON WAS UNRESPONSIVE. ADDITIONALLY, 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 WITH TANDEM TECHNICAL SUPPORT, THEREFORE NO ADDITIONAL INFORMATION COULD BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18799544 ↗
• MalfunctionFeb 22, 2024Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT THE PUMP TOUCHSCREEN WAS UNRESPONSIVE. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE. REPORTEDLY, THE CUSTOMER DECLINED TO PROVIDE ADDITIONAL INFORMATION, AND DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18757423 ↗
• MalfunctionFeb 8, 2024Loose or Intermittent Connection; Incorrect Measurement; Battery Problem; Loose or Intermittent Connection; Incorrect Measurement; Battery Problem

  IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. IT WAS ALSO REPORTED THAT THE PUMP 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 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 18667012 ↗
• MalfunctionJan 31, 2024Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS DELAYED IN RESPONDING TO TOUCH. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE. REPORTEDLY, THE CUSTOMER DECLINED TO PROVIDE ADDITIONAL INFORMATION, AND DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18615440 ↗