t:slim Insulin Pump, Replacement 007264Recalls & reported problems
Tandem Diabetes Care, Inc. · Insulin Pump, Replacement, t:slim · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Tandem t:slim insulin pump is used to deliver insulin. Of its 354 reports, 319 describe malfunctions and 35 describe injuries, with no deaths. Common problems include the pump stopping unexpectedly, battery trouble and incorrect measurements. Most reports describe no effect on the patient, though a few mention high or low blood sugar. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 354
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 354 adverse event reports that list this exact device (DI 00852162004552), received between Jul 9, 2018 and Jan 8, 2025 — classified as 35 injuries, 319 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (71 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.
Reports received per month
Most reported problems
Device problems
- Pumping Stopped71
- Battery Problem68
- Incorrect Measurement39
- Obstruction of Flow36
- Failure to Sense33
- Charging Problem32
- Adverse Event Without Identified Device or Use Problem24
- Device Sensing Problem20
Patient problems
- No Known Impact Or Consequence To Patient135
- No Consequences Or Impact To Patient128
- No Clinical Signs, Symptoms or Conditions60
- Hyperglycemia14
- Hypoglycemia12
- Elevated Ketones/ Diabetic Ketoacidosis5
- No Patient Involvement3
- Fall1
Recent adverse event reports
The 25 most recent of 354 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 8, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PUMP RESET UNEXPECTEDLY. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE CUSTOMER DECLINED FURTHER TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21107276 ↗MalfunctionAug 27, 2024Battery Problem; Device Sensing Problem; Battery Problem; Device Sensing Problem
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE. ADDITIONALLY, IT WAS REPORTED THAT THE WAKE BUTTON WAS STICKING. 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 20079754 ↗MalfunctionJun 3, 2024Incorrect Measurement; Battery Problem; Incorrect Measurement; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY AND THE BATTERY GAUGE WAS FLUCTUATING. 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 19453505 ↗MalfunctionFeb 29, 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. 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 18806686 ↗MalfunctionDec 19, 2023Failure to Sense; Failure to Sense
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN 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 18355821 ↗MalfunctionDec 19, 2023Crack; Failure to Sense; Charging Problem; Crack; Failure to Sense; Charging Problem
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS CRACKED AND UNRESPONSIVE. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP'S USB PORT WAS DAMAGED RESULTING IN DIFFICULTIES CHARGING THE PUMP. 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 18354260 ↗MalfunctionDec 5, 2023Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE WAKE BUTTON WAS STICKING. 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 18265907 ↗MalfunctionDec 1, 2023Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT AND DECLINED TO PROVIDE FURTHER INFORMATION. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18248697 ↗MalfunctionAug 28, 2023Loose or Intermittent Connection; Incorrect Measurement; Charging Problem; Loose or Intermittent Connection; Incorrect Measurement; Charging Problem
IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING. ADDITIONALLY, 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. 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 17632277 ↗MalfunctionMay 17, 2023Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE WAKE BUTTON WAS STICKING. 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 16945798 ↗MalfunctionApr 27, 2023Failure to Sense; Battery Problem; 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. 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 16825725 ↗MalfunctionApr 10, 2023Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. THE CUSTOMER REVERTED TO MANUAL INJECTIONS 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 16709564 ↗MalfunctionNov 22, 2022Incorrect Measurement; Battery Problem; Incorrect Measurement; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. ADDITIONALLY, IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15844295 ↗MalfunctionNov 18, 2022Loose or Intermittent Connection; Battery Problem; Charging Problem; Loose or Intermittent Connection; Battery Problem; Charging Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. ADDITIONALLY, IT WAS 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 15822533 ↗MalfunctionOct 26, 2022Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT AN UNSPECIFIED MALFUNCTION ALARM OCCURRED. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15674426 ↗MalfunctionSep 15, 2022Failure 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 15428900 ↗MalfunctionAug 31, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING THE LOAD SEQUENCE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 188 MG/DL. REPORTEDLY, THE CUSTOMER CLEARED THE ALARM AND RESUMED INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15327987 ↗InjuryAug 3, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A BLOOD GLUCOSE (BG) LEVEL OF 38 MG/DL. REPORTEDLY THE PUMP DELIVERED A BOLUS WITHOUT USER INPUT AND THAT THERE WAS A SETTINGS ISSUE. REPORTEDLY THE CUSTOMER FELL OFF THE BED DUE TO PASSING OUT, INJURED THEIR LEGS AND ARMS AND HAD A SEIZURE. THE CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY HOSPITALIZED IN THE INTENSIVE CARE UNIT. BG WAS TREATED WITH INTRAVENOUS INSULIN AND SALINE. REPORTEDLY, THE CUSTOMER WAS RELEASED ON (B)(6) 2022 WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE. SYSTEM CHECK WITH TANDEM TECHNICAL SUPPORT CONFIRMED THE PUMP WAS FUNCTIONING AS INTENDED.
Patient problems: Fall; Hypoglycemia; Loss of consciousness
MAUDE report 15157724 ↗MalfunctionJun 9, 2022Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. 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 14642912 ↗MalfunctionJun 8, 2022Break; Break
IT WAS REPORTED THAT THE CUSTOMER'S PUMP WAS DAMAGED AND AS A RESULT THE CARTRIDGE WOULD NOT SIT CORRECTLY IN THE PUMP. THE PUMP IS OUTSIDE OF ITS WARRANTY AND THE CUSTOMER IS WORKING TO REPLACE THE PUMP. THE CUSTOMER DECLINED FURTHER ASSISTANCE REGARDING THE ISSUE. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14633806 ↗MalfunctionJun 7, 2022Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING BASAL DELIVERY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 150 MG/DL. REPORTEDLY, THE CUSTOMER CLEARED THE ALARM AND RESUMED INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14621773 ↗MalfunctionJun 3, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED. MULTIPLE ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO GATHER ADDITIONAL INFORMATION, HOWEVER, NO RESPONSE WAS RECEIVED. THERE WAS NO REPORTED ADVERSE IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14592291 ↗MalfunctionMay 19, 2022Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. NO FURTHER INFORMATION WAS OBTAINED AS CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT. THERE WAS NO REPORTED IMPACT TO BLOOD GLUCOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14434833 ↗MalfunctionApr 8, 2022Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. THERE WAS NO REPORTED IMPACT TO BLOOD GLUCOSE. CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14056210 ↗MalfunctionFeb 16, 2022Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT A CARTRIDGE ALARM INTERMITTENTLY OCCURRED DURING BASAL DELIVERY WITH MULTIPLE CARTRIDGES. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13542233 ↗
Other Pump, Infusion, Insulin devices
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- t:slim X2 Insulin Pump 1000103Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin1 recall1 death7,327 reports
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- t:flex Insulin Pump, Replacement, Refurbished 007473Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin2 deaths2,373 reports
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- Accu-Chek Combo 05027250001Roche Diabetes Care GmbH · Pump, Infusion, Insulin1,830 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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