t:slim X2 5.0 Insulin Pump 1003487Recalls & reported problems
Tandem Diabetes Care, Inc. · t:slim X2 5.0 Insulin Pump, Replacement · Class 3
All models of t:slim X2 Insulin Pump (45) · t:slim X2 5.0 Insulin Pump (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This is a Tandem t:slim X2 insulin pump. Many of the 84 reports describe incorrect messages on the screen, battery problems, incorrect readings and the pump stopping or blocking flow. There are 9 injuries and no deaths. There is 1 open recall, from May 2022, over issues that can be addressed with a software update, including memory faults, an inaccurate battery display, a touchscreen that stays on and an unexpected switch out of automatic mode; the recall says these could lead to low or high blood sugar.
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
- 84
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 00853052007967), received between Nov 12, 2018 and Dec 13, 2023 — classified as 9 injuries, 75 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (25 reports).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (P140015); they may or may not involve this specific model.
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 18, 2026.
Reports received per month
Recalls naming this device
- May 24, 2022Class IIOpen, 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Displays Incorrect Message25
- Battery Problem12
- Incorrect Measurement11
- Failure to Sense10
- Obstruction of Flow10
- Adverse Event Without Identified Device or Use Problem6
- Pumping Stopped6
- Charging Problem4
Patient problems
- No Consequences Or Impact To Patient46
- No Known Impact Or Consequence To Patient23
- No Clinical Signs, Symptoms or Conditions7
- Hyperglycemia5
- Hypoglycemia4
- Head Injury1
Recent adverse event reports
The 25 most recent of 84 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2023Crack; Failure to Sense; Battery Problem; Crack; Failure to Sense; Battery Problem
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS CRACKED AND UNRESPONSIVE. ADDITIONALLY, 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 18318238 ↗MalfunctionJan 5, 2023Date/Time-Related Software Problem; Date/Time-Related Software Problem
IT WAS REPORTED THAT THE PUMP TIME WAS INCORRECT, CAUSE WAS UNKNOWN. 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 16104136 ↗MalfunctionDec 29, 2022Date/Time-Related Software Problem; Date/Time-Related Software Problem
IT WAS REPORTED THAT THE PUMP TIME WAS INCORRECT, CAUSE WAS UNKNOWN. 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 16068880 ↗MalfunctionNov 16, 2022Excess Flow or Over-Infusion; Failure to Sense; Device Sensing Problem; Excess Flow or Over-Infusion; Failure to Sense; Device Sensing Problem
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE AND THE WAKE BUTTON WAS STICKING AND UNRESPONSIVE. IT WAS ALSO REPORTED THAT THE PUMP DELIVERED TOO MUCH INSULIN DURING A BOLUS. 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 15811234 ↗MalfunctionNov 12, 2021Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT AN UNSPECIFIED MALFUNCTION ALARM OCCURRED. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 234 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12804868 ↗MalfunctionJun 9, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT CARTRIDGE CHANGE ERRORS OCCURRED WITH MULTIPLE CARTRIDGES DURING THE LOAD SEQUENCE. CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 105 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11966938 ↗MalfunctionFeb 17, 2021Loose or Intermittent Connection; Incorrect Measurement; Charging Problem
IT WAS REPORTED THAT THE BATTERY GAUGE WAS INTERMITTENTLY FLUCTUATING. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP INTERMITTENTLY COULD NOT BE CHARGED PROPERLY WITHOUT THE CUSTOMER MANEUVERING THE CABLE INTO THE CHARGING PORT DUE TO THE CHARGING PORT BEING LOOSE. THERE WAS NO ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED TO FURTHER TROUBLESHOOT WITH TANDEM TECHNICAL SUPPORT. CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11339682 ↗MalfunctionDec 29, 2020Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED TO PROVIDE FURTHER INFORMATION OR PERFORM TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 11088836 ↗MalfunctionAug 27, 2020Failure 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 TOUCHSCREEN WAS DELAYED IN RESPONDING TO PRESSES AND ALSO WAS UNRESPONSIVE. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE. CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10459784 ↗MalfunctionAug 25, 2020Incorrect Measurement; Date/Time-Related Software Problem; Incorrect Measurement; Date/Time-Related Software Problem
IT WAS REPORTED THAT THE PUMP "LOOSES TIME" AND THAT THE "INSULIN GAUGE WAS OFF." THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED TO TROUBLESHOOT WITH TANDEM TECHNICAL SUPPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10448108 ↗MalfunctionAug 6, 2020Battery Problem; Battery Problem
IT WAS REPORTED THAT PUMP BATTERY WAS DEPLETING QUICKLY. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED TO PERFORM TROUBLESHOOTING AND DECLINED FOLLOW UP FROM TANDEM TECHNICAL SUPPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10373328 ↗MalfunctionJun 22, 2020Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER DECLINED SYSTEM CHECK WITH TANDEM SYSTEM SUPPORT. NO FURTHER DETAILS WERE GIVEN. NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10181986 ↗MalfunctionJun 18, 2020Device Displays Incorrect Message; Device Displays Incorrect Message
IT WAS REPORTED THAT CARTRIDGE CHANGE ERRORS OCCURRED WITH MULTIPLE CARTRIDGES DURING THE LOAD SEQUENCE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 328 MG/DL. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10169233 ↗MalfunctionJun 11, 2020Battery 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. MULTIPLE ATTEMPTS WERE MADE TO FOLLOW UP WITH THE CUSTOMER REGARDING THE REPORTED ISSUE; HOWEVER, NO RESPONSE FROM THE CUSTOMER WAS RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10143755 ↗MalfunctionJun 4, 2020Battery 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. THE CUSTOMER DECLINED FOLLOW UP FROM TANDEM TECHNICAL SUPPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10120939 ↗InjuryMay 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CUSTOMER INTERMITTENTLY EXPERIENCED LOW BLOOD GLUCOSE LEVELS (40-50 MG/DL) DUE TO PUMP SETTINGS NEEDING ADJUSTMENT. CUSTOMER CONSUMED CARBOHYDRATES TO TREAT THE LOW BG. RECOMMENDATION WAS MADE FOR THE CUSTOMER TO CONSULT WITH A HEALTHCARE PROVIDER REGARDING SETTINGS ADJUSTMENTS.
Patient problems: Hypoglycemia
MAUDE report 10071501 ↗MalfunctionMay 18, 2020Filling Problem; Incorrect Measurement; Filling Problem; Incorrect Measurement
IT WAS REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED AFTER FILLING THE CARTRIDGE WITH 300 UNITS OF INSULIN. BLOOD GLUCOSE WAS NOT IMPACTED. REPORTEDLY, THE CUSTOMER RELOADED THE SAME CARTRIDGE AND CONTINUED INSULIN THERAPY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10067807 ↗InjuryMay 1, 2020Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER'S BLOOD GLUCOSE (BG) RANGED UP TO 599 MG/DL. NO FURTHER DETAILS WERE PROVIDED.
Patient problems: Hyperglycemia
MAUDE report 10017345 ↗MalfunctionMar 12, 2020Battery 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. THE CUSTOMER DECLINED FOLLOW UP FROM TANDEM TECHNICAL SUPPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9824045 ↗MalfunctionMar 6, 2020Failure to Sense; Failure to Sense
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE. THERE WAS NO KNOWN IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE. REPORTEDLY, CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9801898 ↗MalfunctionFeb 13, 2020Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE INSULIN GAUGE WAS INTERMITTENTLY INACCURATE. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE. CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9707932 ↗MalfunctionFeb 10, 2020Device Displays Incorrect Message; Device Displays Incorrect Message
IT WAS REPORTED THAT CARTRIDGE CHANGE ERRORS OCCURRED WITH MULTIPLE CARTRIDGES DURING THE LOAD SEQUENCE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 260 MG/DL. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9688355 ↗MalfunctionFeb 10, 2020Device Displays Incorrect Message; Device Displays Incorrect Message
IT WAS REPORTED THAT CARTRIDGE CHANGE ERRORS OCCURRED WITH MULTIPLE CARTRIDGES DURING THE LOAD SEQUENCE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 150 MG/DL. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9688088 ↗InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE (BG) WAS 40 MG/DL; CAUSE WAS NOT KNOWN. INFUSION SET WAS CHANGED MULTIPLE TIMES AND CARTRIDGE WAS ALSO CHANGED. CUSTOMER DISCONNECTED FROM THE PUMP AND CONSUMED GLUCOSE TABLES/ FOOD. CUSTOMER'S BG ELEVATED (589 MG/DL). MANUAL INJECTIONS (LANTUS/ HUMALOG) WERE ADMINISTERED TO ADDRESS BG. TANDEM TECHNICAL SUPPORT REVIEWED PUMP DATA AND FOUND PUMP WAS FUNCTIONING PROPERLY.
Patient problems: Hyperglycemia; Hypoglycemia
MAUDE report 9460406 ↗MalfunctionDec 11, 2019Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY INTERMITTENTLY DEPLETED QUICKLY. THE CUSTOMER¿S BLOOD GLUCOSE WAS APPROXIMATELY AROUND 400 MG/DL. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9453093 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P140015. One submission often covers many models, so check the product and lot details in each record.
- Z-2471-2018 · Apr 23, 2018 · Open, Classifiedt:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B.
Other Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor devices
- t:slim X2 5.0 Insulin Pump 1000885Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor1 recall2 deaths17,224 reports
- t:slim X2 5.0 Insulin Pump 1000911Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor2 recalls2 deaths15,928 reports
- t:slim X2 5.0 Insulin Pump 1000897Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor1 recall2 deaths6,444 reports
- t:slim X2 5.x Insulin Pump 1003808Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor2 recalls1 death2,526 reports
- t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM 006194Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor4 deaths2,272 reports
- Animas Vibe 11451100Animas Corporation · Pump, infusion, insulin, to be used with invasive glucose sensor2 deaths2,262 reports
- t:slim X2 5.0 Insulin Pump 1000891Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor1 recall1,561 reports
- Animas Vibe 11451000Animas Corporation · Pump, infusion, insulin, to be used with invasive glucose sensor1,122 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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