t:slim X2 Insulin Pump with Control-IQ Technology 1012869Recalls & reported problems
Tandem Diabetes Care, Inc. · Class 2
All models of t:slim X2 Insulin Pump (45) · t:slim X2 Insulin Pump with Control-IQ Technology (11)
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 named in 892 adverse event reports, with 82 injuries and no deaths. Many describe pumps stopping, battery and charging problems and malfunction alarms, with some mentioning air bubbles in the tubing. One open recall, started in July 2025, covers pumps with certain speakers that may malfunction, which can silence alerts and stop insulin delivery. Reports in the last year fell to 121, from 314 in the year 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
- 892
- Deaths reported
- 0
- Injuries reported
- 81
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 892 adverse event reports that list this exact device (DI 00389152286914), received between Jan 5, 2024 and Sep 30, 2026 — classified as 81 injuries, 811 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (307 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
- Jul 21, 2025Class IOpen, Classified
Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a hyperglycemic event, which may lead to injury and/or hospitalization.
Z-2343-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Pumping Stopped307
- Battery Problem142
- Charging Problem100
- Incorrect Measurement70
- Obstruction of Flow47
- Adverse Event Without Identified Device or Use Problem37
- Communication or Transmission Problem36
- Failure to Sense27
Patient problems
- No Clinical Signs, Symptoms or Conditions811
- Hyperglycemia56
- Hypoglycemia26
- Confusion/ Disorientation1
- Elevated Ketones/ Diabetic Ketoacidosis1
- Shaking/Tremors1
Recent adverse event reports
The 25 most recent of 892 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Insufficient Device Problem Information
It was reported that intermittent pump failure occurred. Reportedly, the customer restart the pump to address the issue. 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 50948412 ↗MalfunctionSep 30, 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 50948108 ↗MalfunctionSep 29, 2026Loose or Intermittent Connection; Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934280 ↗MalfunctionAug 17, 2026Incorrect Measurement
It was reported that a minimum fill notification occurred after the user filled the cartridge with 180 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 50276990 ↗MalfunctionJul 8, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT INTERMITTENTLY THE PUMP ¿ERRORED OUT A COUPLE TIMES¿. CUSTOMER CHANGED THE SUPPLIES TO RESOLVE THE ISSUES. 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 25747106 ↗MalfunctionJun 29, 2026Pumping Stopped
IT WAS REPORTED THAT PUMP EXPERIENCED MALFUNCTION ALARM WITH CODE MALF 12, WITH NO NOTABLE EVENTS OCCURRING BEFOREHAND. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER CONTACTED TECHNICAL SUPPORT, RECEIVED INSTRUCTIONS TO RESET PUMP, SUCCESSFULLY COMPLETED RESET WITHOUT RECURRENCE OF MALFUNCTION, WAS ADVISED TO CONTINUE USING PUMP, AND WAS INSTRUCTED TO CALL BACK IF MALFUNCTION CODE APPEARED AGAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25658452 ↗MalfunctionJun 15, 2026Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS INTERMITTENTLY 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 25504669 ↗MalfunctionJun 11, 2026Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THE WAKE BUTTON ON THE PUMP WAS STICKING OR UNRESPONSIVE. 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 25472580 ↗MalfunctionJun 9, 2026Pumping Stopped
IT WAS REPORTED THAT PUMP EXPERIENCED MALFUNCTION ALARM WITH NO NOTABLE EVENTS OCCURRING BEFOREHAND. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER CONTACTED TECHNICAL SUPPORT, WAS GUIDED THROUGH PUMP RESET, CONFIRMED MALFUNCTION DID NOT RECUR AFTER RESET, WAS ADVISED TO CONTINUE USING PUMP, AND WAS INSTRUCTED TO CALL BACK IF MALFUNCTION ALARM HAPPENED AGAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25442852 ↗MalfunctionJun 8, 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 ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25436973 ↗MalfunctionJun 8, 2026Pumping Stopped
IT WAS REPORTED THAT PUMP EXPERIENCED MALFUNCTION ALARM WITH CODE DISPLAYED AND CALLER CONFIRMED NO NOTABLE EVENTS OCCURRED BEFORE ISSUE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER CONTACTED SUPPORT, RECEIVED INSTRUCTIONS TO RESET PUMP, SUCCESSFULLY RESET DEVICE WITHOUT MALFUNCTION RECURRING, WAS ADVISED TO CONTINUE USING PUMP AND TO CALL BACK IF MALFUNCTION RETURNED, AND CONFIRMED UNDERSTANDING OF GUIDANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25431202 ↗MalfunctionMay 29, 2026Pumping Stopped
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. DURING TROUBLESHOOTING WITH TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED, AND INSULIN DELIVERY WAS RESUMED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25332662 ↗MalfunctionMay 27, 2026Mechanical Problem
IT WAS REPORTED THAT PUMP DISPLAYED CARTRIDGE CHANGE ERROR DURING LOAD PROCESS. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER RELOADED CARTRIDGE, CONFIRMED ABILITY TO COMPLETE LOAD PROCESS, AND SUCCESSFULLY RESUMED INSULIN DELIVERY WITHOUT FURTHER INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25301240 ↗MalfunctionMay 20, 2026Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THE PUMP TOUCHSCREEN "DID NOT WORK" AT TIMES. 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 25230191 ↗MalfunctionMay 20, 2026Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THE WAKE BUTTON ON THE PUMP WAS NOT WORKING INTERMITTENTLY. 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 25230183 ↗MalfunctionMay 19, 2026Charging Problem
IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO CHARGE THE PUMP DUE TO DAMAGE TO THE TANDEM-PROVIDED USB CHARGING CABLE. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. A NEW CHARGING CABLE WAS SENT TO THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25219600 ↗MalfunctionMay 19, 2026Date/Time-Related Software Problem
IT WAS REPORTED THAT THE PUMP TIME WAS INCORRECT, CAUSE WAS UNKNOWN. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE CUSTOMER CORRECTED THE TIME AND RESUMED INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25217364 ↗MalfunctionMay 15, 2026Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THE WAKE BUTTON WAS STICKING. 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 25186411 ↗MalfunctionMay 7, 2026Incorrect Measurement
IT WAS REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 300 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 25118109 ↗MalfunctionMay 7, 2026Scratched Material
IT WAS REPORTED THAT THE PUMP TOUCHSCREEN WAS SCRATCHED, CAUSING ISSUES WITH THE RESPONSIVENESS OF THE TOUCHSCREEN. 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 25117148 ↗MalfunctionMay 7, 2026Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THERE WERE UNSPECIFIED ISSUES WITH THE WAKE BUTTON ON THE PUMP. 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 25117141 ↗MalfunctionMay 7, 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 25117126 ↗MalfunctionMay 7, 2026Pumping Stopped
IT WAS REPORTED THAT PUMP MALFUNCTION OCCURRED WITHOUT ANY NOTABLE EVENTS BEFOREHAND. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER CONTACTED SUPPORT, RECEIVED INSTRUCTIONS TO RESET PUMP, SUCCESSFULLY CLEARED MALFUNCTION WITHOUT RECURRENCE, WAS ADVISED TO CONTINUE USING PUMP, AND WAS INSTRUCTED TO CALL BACK IF MALFUNCTION CODE APPEARED AGAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25111564 ↗MalfunctionMay 5, 2026Failure to Charge
IT WAS REPORTED THAT T:SLIM X2 PUMP BATTERY WOULD NOT CHARGE. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED TROUBLESHOOTING, AND NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE OUTCOME OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25083425 ↗MalfunctionMay 4, 2026Inappropriate or Unexpected Reset
IT WAS REPORTED THAT AN UNEXPECTED RESET OCCURRED. THERE WAS NO REPORTED 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 25069272 ↗
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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