t:slim Insulin Pump, Reconditioned Replacement 007262Recalls & reported problems
Tandem Diabetes Care, Inc. · t:slim Insulin Pump, Reconditioned Replacement · Class 2
Quick summary
This Tandem t:slim insulin pump is a reconditioned replacement unit that delivers insulin. Reports most often describe batteries draining quickly, the pump stopping, and incorrect readings. Many report no known impact on the patient. The device appears in 5,253 reports, including 2 deaths and 600 injuries. No recalls name this device. Reports dropped to 2 in the last 12 months from 19 before.
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
- 5,253
- Deaths reported
- 2
- Injuries reported
- 600
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5,253 adverse event reports that list this exact device (DI 00852162004545), received between Jan 26, 2018 and Feb 19, 2026 — classified as 2 deaths, 600 injuries, 4,651 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (951 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Battery Problem951
- Pumping Stopped945
- Incorrect Measurement665
- Obstruction of Flow606
- Failure to Sense572
- Charging Problem551
- Adverse Event Without Identified Device or Use Problem298
- Device Sensing Problem248
Patient problems
- No Known Impact Or Consequence To Patient1,938
- No Consequences Or Impact To Patient1,775
- No Clinical Signs, Symptoms or Conditions956
- Hyperglycemia358
- Hypoglycemia181
- Elevated Ketones/ Diabetic Ketoacidosis101
- Loss of consciousness13
- No Patient Involvement8
Recent adverse event reports
The 25 most recent of 5,253 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 19, 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. MULTIPLE ATTEMPTS WERE MADE BY TANDEM¿S TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24388226 ↗MalfunctionDec 9, 2025Premature Discharge of Battery; Premature Discharge of Battery
A CUSTOMER REPORTED THAT THE BATTERY WAS DEPLETING TOO QUICKLY. 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 23753320 ↗MalfunctionOct 16, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED "TOUCHSCREEN DOES NOT ALWAYS REACT TO TOUCH". THERE WAS NO 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 23309795 ↗MalfunctionOct 16, 2025Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED TO TROUBLESHOOT THE ISSUE WITH TANDEM TECHNICAL SUPPORT, THEREFORE NO ADDITIONAL INFORMATION WAS OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23308248 ↗MalfunctionOct 15, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE. 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 23278438 ↗MalfunctionSep 18, 2025False Alarm; False Alarm
PUMP REPORTED AN ALTITUDE ALARM ISSUE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL DID NOT EXCEED 500 MG/DL, INDICATING THERE WAS NO ADVERSE IMPACT ON THEIR BLOOD GLUCOSE LEVEL. CUSTOMER WAS ABLE TO RESUME INSULIN WITH THE ORIGINAL CARTRIDGE AFTER RECEIVING TIPS FROM TECHNICAL SUPPORT ON PREVENTING ALTITUDE ALARMS, WHICH THEY ACKNOWLEDGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23085075 ↗MalfunctionSep 17, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THE WAKE BUTTON ON THE PUMP WAS STICKING. THERE WAS NO PATIENT INVOLVEMENT, AS THE PUMP WAS BEING USED FOR DEMONSTRATION PURPOSES ONLY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23077750 ↗MalfunctionAug 22, 2025Premature Discharge of Battery; Premature Discharge of Battery
JACOB CHAPPELL REPORTED BATTERY DRAINAGE. THERE WAS NO REPORTED IMPACT ON JACOB'S BLOOD GLUCOSE LEVEL. JACOB DECLINED ADDITIONAL FOLLOW-UP, AND NO FURTHER ACTIONS OR OUTCOMES WERE DETAILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22872202 ↗MalfunctionJul 21, 2025Failure to Charge; Pumping Stopped; Failure to Charge; Pumping Stopped
IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED WHICH RESULTED IN THE PUMP SHUTTING DOWN. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22553376 ↗MalfunctionJun 26, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED. 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 22338616 ↗MalfunctionMay 13, 2025Battery 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. REPORTEDLY THE CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22013207 ↗MalfunctionApr 28, 2025Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. THERE WAS NO 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 21918233 ↗MalfunctionApr 25, 2025False Alarm; False Alarm
IT WAS REPORTED THAT AN ALTITUDE ALARM OCCURRED. REPORTEDLY, THE PUMP WAS NOT OUTSIDE THE LABELED ALTITUDE OPERATING RANGE. THERE WAS NO ADVERSE IMPACT TO CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER CLEANED THE SPEAKER HOLES, LOADED A NEW CARTRIDGE, AND INSULIN DELIVERY WAS RESUMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21914975 ↗MalfunctionApr 25, 2025Crack; Failure to Sense; Crack; Failure to Sense
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS SCRATCHED AND UNRESPONSIVE. 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 21911845 ↗MalfunctionMar 20, 2025Pumping 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 21654575 ↗MalfunctionMar 17, 2025Battery 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. REPORTEDLY THE CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21621045 ↗MalfunctionJan 9, 2025Pumping 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 ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21114997 ↗MalfunctionNov 27, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS ON, BUT THE DISPLAY REMAINED BLACK. THERE WAS NO REPORTED ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20790298 ↗MalfunctionNov 13, 2024Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING. 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 20678559 ↗MalfunctionNov 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PUMP WAS NOT WORKING PROPERLY. THERE WAS NO REPORTED 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 20675614 ↗MalfunctionNov 8, 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 TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THEREFORE NO ADDITIONAL INFORMATION COULD BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20641005 ↗MalfunctionOct 28, 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 20551405 ↗MalfunctionOct 24, 2024Failure 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 THE ISSUE WITH TANDEM TECHNICAL SUPPORT, THEREFORE NO ADDITIONAL INFORMATION WAS OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20527891 ↗MalfunctionOct 22, 2024Failure to Sense; Failure to Sense
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE. 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 20509055 ↗MalfunctionOct 21, 2024Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. 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 20500619 ↗
Other Pump, Infusion, Insulin devices
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- Omnipod ZXP420Insulet Corporation · Pump, Infusion, Insulin1 recall17 deaths37,832 reports
- Omnipod ZXP420Insulet Corporation · Pump, Infusion, Insulin70 deaths20,092 reports
- t:slim X2 Insulin Pump 1000103Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin1 recall1 death7,327 reports
- t:flex Insulin Pump, Replacement, Refurbished 007473Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin2 deaths2,373 reports
- t:slim Insulin Pump 007435Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin7 deaths2,104 reports
- Accu-Chek Combo 05027250001Roche Diabetes Care GmbH · Pump, Infusion, Insulin1,830 reports
- t:slim X2 Insulin Pump 1000369Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin1 recall1,640 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.