t:slim X2 Insulin Pump 1000369Recalls & reported problems
Tandem Diabetes Care, Inc. · t:slim X2 Insulin Pump, Reconditioned, 4YR Warranty · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This is the Tandem t:slim X2 insulin pump. The 1,640 reports often describe the pump stopping, charging problems, inaccurate readings, and flow blockages. Some mention blood sugar running too high or too low. The records include no deaths, 188 injuries and 1,452 malfunctions. There is 1 open recall from May 2022 over memory faults and an inaccurate battery display.
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
- 1,640
- Deaths reported
- 0
- Injuries reported
- 188
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1,640 adverse event reports that list this exact device (DI 00852162004798), received between Mar 6, 2017 and Aug 26, 2025 — classified as 188 injuries, 1,452 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (295 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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Pumping Stopped295
- Charging Problem243
- Incorrect Measurement230
- Obstruction of Flow192
- Battery Problem146
- Adverse Event Without Identified Device or Use Problem128
- Failure to Sense96
- Physical Resistance/Sticking93
Patient problems
- No Consequences Or Impact To Patient723
- No Clinical Signs, Symptoms or Conditions596
- No Known Impact Or Consequence To Patient141
- Hyperglycemia95
- Hypoglycemia77
- Elevated Ketones/ Diabetic Ketoacidosis23
- Insufficient Information5
- Loss of consciousness3
Recent adverse event reports
The 25 most recent of 1,640 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 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 CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22897534 ↗MalfunctionJul 11, 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 22481318 ↗InjuryMay 9, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT CARTRIDGE CHANGE ERRORS OCCURRED WITH MULTIPLE CARTRIDGES DURING THE LOAD SEQUENCE. A NEW CARTRIDGE WAS LOADED TO RESOLVE THE ISSUE. CUSTOMER WENT TO THE EMERGENCY ROOM (ER) WITH A BLOOD GLUCOSE (BG) LEVEL OF 400 MG/DL. CUSTOMER WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN. CUSTOMER WAS DISCHARGED LATER THE SAME DAY WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE.
Patient problems: Hyperglycemia
MAUDE report 21994184 ↗MalfunctionMay 8, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT AND DECLINED TO PROVIDE FURTHER INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21988937 ↗MalfunctionApr 25, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A CARTRIDGE CHANGE ERROR OCCURRED. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE PUMP 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 21914528 ↗MalfunctionJan 28, 2025Charging Problem; Charging Problem
IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO CHARGE THE PUMP USING THE TANDEM-PROVIDED USB CHARGING CABLE. THERE WAS NO ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER WAS ABLE TO SUCCESSFULLY CHARGE THE PUMP USING A SECONDARY USB CABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21257452 ↗MalfunctionNov 8, 2024Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT AN UNEXPECTED RESET OCCURRED. THERE WAS NO REPORTED IMPACT TO CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20646467 ↗MalfunctionOct 28, 2024Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT THE "PUMP DOES NOT TURN ON." THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, AND ADDITIONAL INFORMATION COULD NOT BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20550428 ↗MalfunctionJul 26, 2024Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. THE CUSTOMER DECLINED FOLLOW-UP FROM TANDEM TECHNICAL SUPPORT REGARDING THE ISSUE, THEREFORE NO ADDITIONAL INFORMATION WAS OBTAINED. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19842870 ↗InjuryJun 25, 2024Pumping 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. IT WAS ALSO REPORTED THAT THE CUSTOMER EXPERIENCED AN ELEVATED BLOOD GLUCOSE (BG) LEVEL WAS "HIGH", ALTHOUGH A SPECIFIC VALUE WAS NOT GIVEN. CUSTOMER ADMINISTERED A MANUAL INJECTION TO ADDRESS THEIR BG LEVEL. CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.
Patient problems: Hyperglycemia
MAUDE report 19607185 ↗MalfunctionJun 11, 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 19512216 ↗MalfunctionApr 2, 2024Crack; Charging Problem; Crack; Charging Problem
IT WAS REPORTED THAT THE PUMP'S USB PORT WAS DAMAGED RESULTING IN DIFFICULTIES CHARGING THE PUMP. THERE WAS NO ADVERSE IMPACT TO CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19019224 ↗MalfunctionJan 25, 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 18579531 ↗MalfunctionJan 11, 2024Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER CONTACTED THEIR HEALTHCARE PROVIDER TO OBTAIN ALTERNATE INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18495459 ↗InjuryDec 28, 2023Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 500 MG/DL. CUSTOMER ADDRESSED BG WITH A CORRECTION BOLUS VIA THE PUMP.
Patient problems: Hyperglycemia
MAUDE report 18410439 ↗MalfunctionDec 26, 2023Charging Problem; Charging Problem
IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. THERE WAS NO REPORTED ADVERSE IMPACT TO CUSTOMER'S BLOOD GLUCOSE LEVEL. ADDITIONAL INFORMATION WAS NOT RECEIVED. THE CUSTOMER DECLINED FURTHER TROUBLESHOOTING FROM TANDEM TECHNICAL SUPPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18393936 ↗MalfunctionDec 8, 2023Incorrect Measurement; Pumping Stopped; Charging Problem; Incorrect Measurement; Pumping Stopped; Charging Problem
IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP SHUT OFF UNEXPECTEDLY. IT WAS ALSO REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. 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 18290926 ↗MalfunctionNov 22, 2023Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING. 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 18193848 ↗MalfunctionNov 21, 2023Charging Problem; Charging Problem
IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. THERE WAS NO REPORTED ADVERSE IMPACT TO CUSTOMER'S BLOOD GLUCOSE LEVEL. MULTIPLE FOLLOW UP ATTEMPTS FROM TANDEM TECHNICAL SUPPORT WAS MADE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, A RESPONSE FROM THE CUSTOMER WAS NOT RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18184418 ↗MalfunctionNov 9, 2023Failure to Sense; Failure to Sense
IT WAS REPORTED THAT THE PUMP TOUCHSCREEN WAS UNRESPONSIVE. CUSTOMER'S BLOOD WAS 185 MG/DL. REPORTEDLY THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18100473 ↗MalfunctionOct 25, 2023Failure to Sense; Date/Time-Related Software Problem; Battery Problem; Failure to Sense; Date/Time-Related Software Problem; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY, THAT THE TOUCH SCREEN WAS UNRESPONSIVE AND THAT THE PUMP TIME WAS INCORRECT, CAUSE WAS UNKNOWN. CUSTOMER DECLINED TO TROUBLESHOOT THE ISSUE WITH TANDEM TECHNICAL SUPPORT; THEREFORE THE ALLEGATION COULD NOT BE CONFIRMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18002287 ↗MalfunctionOct 24, 2023Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE AND THE BATTERY GAUGE WAS FLUCTUATING. CUSTOMER LOADED A NEW CARTRIDGE TO RESOLVE THE ISSUE. 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 17995552 ↗MalfunctionOct 10, 2023Failure to Sense; Obstruction of Flow; Failure to Sense; Obstruction of Flow
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE. ADDITIONALLY, 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 17904869 ↗MalfunctionOct 6, 2023Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT THE PUMP SHUT OFF UNEXPECTEDLY. THE CUSTOMER DECLINED A FOLLOW UP, SO NO ADDITIONAL INFORMATION WAS OBTAINED. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17887526 ↗MalfunctionSep 29, 2023Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS MISSING PIXELS. 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 17844124 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.