t:slim X2 Insulin Pump with Basal-IQ 1006373Recalls & reported problems
Tandem Diabetes Care, Inc. · t:slim X2 Insulin Pump with Basal-IQ, 6.4.x · Class 2
All models of t:slim X2 Insulin Pump (45) · t:slim X2 Insulin Pump with Basal-IQ (14)
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 Tandem t:slim X2 insulin pump is worn to deliver insulin. Reports mostly describe pumps that stop, batteries that cannot charge or drain quickly, incorrect measurements, and blockage alarms. There are 7,490 reports, with no deaths and 790 injuries. One open recall, begun in May 2022, covers software and display problems that could cause high or low blood sugar. Reports fell to 183 in the last 12 months from 1,074 in the 12 months 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
- 7,488
- Deaths reported
- 0
- Injuries reported
- 791
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 7,488 adverse event reports that list this exact device (DI 00850006613700), received between Sep 10, 2020 and Aug 20, 2026 — classified as 791 injuries, 6,697 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (1,900 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. 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
- Pumping Stopped1,900
- Charging Problem825
- Incorrect Measurement783
- Battery Problem621
- Adverse Event Without Identified Device or Use Problem505
- Obstruction of Flow487
- Failure to Sense456
- Crack439
Patient problems
- No Clinical Signs, Symptoms or Conditions6,487
- Hyperglycemia437
- Hypoglycemia306
- No Consequences Or Impact To Patient199
- Elevated Ketones/ Diabetic Ketoacidosis59
- Insufficient Information34
- No Known Impact Or Consequence To Patient28
- Loss of consciousness14
Recent adverse event reports
The 25 most recent of 7,488 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50355033 ↗MalfunctionAug 19, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50332352 ↗MalfunctionAug 19, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50325574 ↗MalfunctionAug 7, 2026Incorrect Measurement
It was reported that a minimum fill notification occurred after the user filled the cartridge with 200 units of insulin during the load sequence. A new cartridge was loaded to resolve the issue. There was no adverse impact to the customer¿s blood glucose level.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50181696 ↗InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the customer experienced an elevated blood glucose (BG) level displayed as "High"; although specific value was not provided. Cause was not known. Customer performed a supply change to address the BG. Recommendation was made to consult a healthcare provider in regards to diabetes management.
Patient problems: Hyperglycemia
MAUDE report 50160745 ↗MalfunctionJul 10, 2026Failure to Charge
IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. 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 25782505 ↗MalfunctionJul 10, 2026Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE. 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 25781017 ↗MalfunctionJul 9, 2026Key or Button Unresponsive/not Working
IT WAS REPORTED THAT PUMP HAD UNRESPONSIVE WAKE BUTTON, AND PATIENT DID NOT WANT TO PERFORM TROUBLESHOOTING. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING ANY CORRECTIVE ACTIONS TAKEN BY THE CUSTOMER OR TECHNICAL SUPPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25771675 ↗MalfunctionJul 8, 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. THE CUSTOMER DECLINED ASSISTANCE FROM TANDEM TECHNICAL SUPPORT REGARDING THE ISSUES. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25757008 ↗MalfunctionJul 8, 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. THE CUSTOMER DECLINED ASSISTANCE FROM TANDEM TECHNICAL SUPPORT REGARDING THE ISSUES. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25757007 ↗MalfunctionJul 8, 2026Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THE TOUCHSCREEN "WILL NOT ALWAYS RESPOND". 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 25752680 ↗MalfunctionJul 8, 2026Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THE PUMP TOUCHSCREEN WAS DELAYED IN RESPONDING TO TOUCH INPUTS. 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 25751606 ↗MalfunctionJul 8, 2026Loose or Intermittent Connection; Charging Problem
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. 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 25750277 ↗MalfunctionJul 8, 2026Pumping Stopped
IT WAS REPORTED THAT PUMP EXPERIENCED RECURRING MONTHLY MALFUNCTIONS THAT REQUIRED PATIENT TO RESTART PUMP MULTIPLE TIMES, BUT NO SPECIFIC MALFUNCTION DETAILS OR DATES WERE PROVIDED. NO INFORMATION WAS RECEIVED REGARDING ANY IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL. PATIENT DECLINED FURTHER FOLLOW UP WITH TECHNICAL SUPPORT, AND NO CORRECTIVE ACTIONS OR ADDITIONAL TROUBLESHOOTING WERE DOCUMENTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25748075 ↗MalfunctionJul 6, 2026Premature Discharge of Battery
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING 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 25716807 ↗MalfunctionJul 6, 2026Charging Problem
IT WAS REPORTED THAT CHARGING CORD REQUIRED EXTRA FORCE TO PLUG IN, AND THIS CONCERN WAS COMMUNICATED THROUGH A DOCUMENT-ONLY EMAIL. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER HAD ALREADY DISCUSSED ISSUE WITH SUPPORT TEAM AND DECLINED FURTHER FOLLOW-UP FROM TECHNICAL SUPPORT, AND NO ADDITIONAL CORRECTIVE ACTIONS OR OUTCOMES WERE DOCUMENTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25716330 ↗MalfunctionJul 1, 2026Key or Button Unresponsive/not Working
IT WAS REPORTED THAT PUMPTOUCHSCREEN BEING SOMETIMES UNRESPONSIVE. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED FURTHER TROUBLESHOOTING AND FOLLOW-UP, AND CASE WAS CLOSED WITH NO ADDITIONAL ACTIONS TAKEN OR INFORMATION RECEIVED REGARDING THE OUTCOME OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25679744 ↗MalfunctionJun 30, 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. 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 25667681 ↗MalfunctionJun 29, 2026Failure to Charge
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 25656071 ↗MalfunctionJun 26, 2026Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THE WAKE BUTTON WAS NOT WORKING. THERE WAS NO ADVERSE IMPACT TO THE 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 25640256 ↗MalfunctionJun 26, 2026Incorrect Measurement
IT WAS REPORTED THAT THE BATTERY GAUGE WAS INACCURATE. 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 25637644 ↗MalfunctionJun 26, 2026Premature Discharge of Battery
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING 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 25633899 ↗MalfunctionJun 26, 2026Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THE WAKE BUTTON WAS NOT WORKING. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER. CUSTOMER DECLINED FURTHER TROUBLESHOOTING WITH TECHNICAL SUPPORT, ADDITIONAL INFORMATION WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25631681 ↗MalfunctionJun 25, 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. 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 25627175 ↗MalfunctionJun 17, 2026Pumping 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. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25535672 ↗
Other Alternate Controller Enabled Insulin Infusion Pump devices
- t:slim X2 Insulin Pump with Control-IQ 1006402Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump2 recalls18 deaths159,247 reports
- t:slim X2 Insulin Pump with Control-IQ 1006408Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump2 recalls12 deaths92,526 reports
- t:slim X2 Insulin Pump with Control-IQ 1009637Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall4 deaths83,884 reports
- Omnipod 5 Pod POD-BLE-H1-520Insulet Corporation · Alternate Controller Enabled Insulin Infusion Pump1 recall75 deaths71,459 reports
- Omnipod 5 Pod POD-OMNI-I1-6720Insulet Corporation · Alternate Controller Enabled Insulin Infusion Pump2 recalls11 deaths61,198 reports
- t:slim X2 Insulin Pump with Control-IQ 1009643Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall7 deaths51,110 reports
- t:slim X2 Insulin Pump with Control-IQ Technology 1013198Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall8 deaths47,637 reports
- t:slim X2 Insulin Pump with Control-IQ 1006404Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall18 deaths43,718 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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