t:slim X2 Insulin Pump with Basal-IQ 1006379Recalls & reported problems
Tandem Diabetes Care, Inc. · t:slim X2 Insulin Pump with Basal-IQ, 6.4.x, Refurbished Replacement · Class 2
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Tandem t:slim X2 Basal-IQ insulin pump has 16,720 adverse event reports in the FDA database, including 1,532 injuries and no deaths. Reports often describe pumping stopping, incorrect measurements, and charging or battery problems. There are 2 open recalls: one about speakers that may fail and silence alerts, and one about battery display, touchscreen, and memory issues that a software update can address. Reports in the last 12 months (249) are well below the 12 months before (979).
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
- 16,712
- Deaths reported
- 0
- Injuries reported
- 1,531
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 16,712 adverse event reports that list this exact device (DI 00850006613731), received between Sep 2, 2020 and Sep 29, 2026 — classified as 1,531 injuries, 15,181 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (4,258 reports).
2 FDA recall records name this device's identifier, 2 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
- Jul 21, 2025Open, 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 · FDA record ↗
- 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 Stopped4,258
- Failure to Sense1,991
- Charging Problem1,944
- Incorrect Measurement1,795
- Battery Problem1,693
- Obstruction of Flow1,225
- Crack914
- Adverse Event Without Identified Device or Use Problem897
Patient problems
- No Clinical Signs, Symptoms or Conditions14,762
- Hyperglycemia971
- Hypoglycemia478
- No Consequences Or Impact To Patient366
- Elevated Ketones/ Diabetic Ketoacidosis150
- No Known Impact Or Consequence To Patient78
- Insufficient Information56
- Loss of consciousness25
Recent adverse event reports
The 25 most recent of 16,712 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936575 ↗MalfunctionSep 29, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932927 ↗MalfunctionAug 21, 2026Insufficient Device Problem Information
It was reported that pump repeatedly suspended insulin during delivery. 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 50369774 ↗MalfunctionAug 20, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50359481 ↗MalfunctionJul 8, 2026Incorrect Measurement; Pumping Stopped
IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING RESULTING IN THE PUMP SHUTTING DOWN. 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 25751860 ↗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 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 25750677 ↗MalfunctionJul 7, 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 25732592 ↗MalfunctionJul 2, 2026Scratched Material
IT WAS REPORTED THAT THE PUMP TOUCHSCREEN WAS SCRATCHED AND UNREADABLE. 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 25697070 ↗MalfunctionJun 30, 2026Scratched Material
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNREADABLE. CUSTOMER DECLINED FOLLOW UP FROM TANDEM TECHNICAL SUPPORT. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER. CUSTOMER DECLINED TROUBLESHOOTING. NO FURTHER ACTION NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25669864 ↗MalfunctionJun 29, 2026Charging Problem
IT WAS REPORTED THAT CUSTOMER EXPERIENCED ISSUES WITH CURRENT PUMP. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED TROUBLESHOOTING AND FOLLOW-UP FROM TECHNICAL SUPPORT AND PROCEEDED WITH PROCESS FOR RENEWAL PUMP, AND NO FURTHER ACTION WAS TAKEN BY TECHNICAL SUPPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25653465 ↗MalfunctionJun 26, 2026Mechanical Problem
IT WAS REPORTED THAT CARTRIDGE CHANGE ERRORS OCCURRED WITH MULTIPLE CARTRIDGES DURING THE LOAD SEQUENCE. CUSTOMER REVERTED TO MANUAL INJECTIONS 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 25637329 ↗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 25627184 ↗MalfunctionJun 25, 2026Incorrect Measurement
IT WAS REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 250 UNITS OF INSULIN DURING THE LOAD SEQUENCE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER RELOADED THE CARTRIDGE TO RESOLVE THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25623413 ↗MalfunctionJun 24, 2026Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THE WAKE BUTTON ON THE PUMP WAS DELAYED IN RESPONDING TO BEING PRESSED. 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 25611744 ↗MalfunctionJun 23, 2026Premature Discharge of Battery
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 25598484 ↗MalfunctionJun 22, 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 25578012 ↗MalfunctionJun 18, 2026Pumping Stopped
IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25552973 ↗MalfunctionJun 18, 2026Break
IT WAS REPORTED THAT THE RACK PUSHROD ON THE PUMP WAS DAMAGED (RUBBER GASKET WAS MISSING OR BECAME DETACHED), WHICH LED TO DIFFICULTIES LOADING CARTRIDGES. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER CONTINUED USING THE PUMP FOR INSULIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25551767 ↗MalfunctionJun 12, 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 25490743 ↗MalfunctionJun 12, 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 25487775 ↗MalfunctionJun 11, 2026Pumping Stopped
IT WAS REPORTED THAT PUMP EXPERIENCED MALFUNCTION WITH CODE DISPLAYED AND NO NOTABLE EVENTS OCCURRED BEFOREHAND. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER CONTACTED SUPPORT, RECEIVED INSTRUCTIONS TO RESET PUMP, SUCCESSFULLY RESET IT WITHOUT RECURRENCE OF MALFUNCTION CODE, WAS ADVISED TO CONTINUE USING PUMP, AND WAS INSTRUCTED TO CALL BACK IF MALFUNCTION RETURNED, WHICH CUSTOMER UNDERSTOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25473419 ↗MalfunctionJun 10, 2026Pumping Stopped
IT WAS REPORTED THAT UNSPECIFIED ALARM 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 25462436 ↗MalfunctionJun 8, 2026Pumping Stopped
A MALFUNCTION WAS REPORTED ON THE PUMP. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT PROVIDED INFORMATION TO RESET THE PUMP, ASSISTED THE CALLER WITH THE RESET, AND CONFIRMED THAT THE MALFUNCTION CODE DID NOT RECUR. THE CUSTOMER WAS ADVISED TO CONTINUE USING THE PUMP FOR INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25437060 ↗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 25436748 ↗MalfunctionJun 8, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PUMP WAS NOT WORKING PROPERLY. 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 25428615 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.