t:slim X2 Insulin Pump with Control-IQ 1006404Recalls & reported problems
Tandem Diabetes Care, Inc. · t:slim X2 Insulin Pump with Control-IQ, 7.4.x, Medicare · Class 2
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 with Control-IQ, Medicare version. Its reports mostly describe pump stoppages, incorrect measurements, charging and cartridge filling problems, and blocked flow. There are 43,740 reports, including 18 deaths and 6,399 injuries. One recall, started in May 2022, is open: memory faults, an inaccurate battery display and a touchscreen that stays on. Reports dropped to 1,465 in the last 12 months, from 5,326 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
- 43,718
- Deaths reported
- 18
- Injuries reported
- 6,401
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 43,718 adverse event reports that list this exact device (DI 00850006613779), received between Aug 27, 2020 and Sep 30, 2026 — classified as 18 deaths, 6,401 injuries, 37,299 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (9,866 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 Stopped9,866
- Incorrect Measurement5,665
- Charging Problem4,740
- Adverse Event Without Identified Device or Use Problem4,469
- Filling Problem3,359
- Obstruction of Flow2,730
- Communication or Transmission Problem2,232
- Battery Problem1,932
Patient problems
- No Clinical Signs, Symptoms or Conditions36,629
- Hyperglycemia3,819
- Hypoglycemia2,438
- No Consequences Or Impact To Patient609
- Elevated Ketones/ Diabetic Ketoacidosis431
- Insufficient Information149
- Loss of consciousness122
- No Known Impact Or Consequence To Patient89
Recent adverse event reports
The 25 most recent of 43,718 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951677 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
It was reported that pump touchscreen responded slowly. There was no reported impact to the customer¿s blood glucose level. Customer declined further technical support follow-up, and no additional information was received regarding the outcome of the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948837 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
It was reported that the wake button on the pump was not working. 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 50948501 ↗MalfunctionSep 29, 2026Pumping Stopped
It was reported that pump experienced malfunction alarm identified as Malf 12, with no events occurring before the issue. There was no adverse impact to the customer¿s blood glucose level. Customer contacted Technical Support, received instructions to reset pump, successfully reset malfunction alarm, and was advised to continue using pump and call back if problem recurred, which did not happen after reset.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931034 ↗MalfunctionSep 28, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924217 ↗MalfunctionSep 28, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924155 ↗InjurySep 28, 2026Use of Device Problem
Patient problems: Hyperglycemia
MAUDE report 50923655 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hypoglycemia
MAUDE report 50922297 ↗MalfunctionSep 28, 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 50914791 ↗InjuryAug 21, 2026Use of Device Problem
It was reported that the pump displayed a minimum fill notification. Reportedly the customer initially filled the cartridge with 60 units of insulin. Technical support educated the customer of the minimum fill recommendation for the pump. The customer¿s blood glucose (BG) level was displayed as ¿High¿; however, a specific value was not provided. Customer changed out supplies and then administrated a correction bolus via pump to address BG. Customer added more insulin to the cartridge and resumed insulin delivery.
Patient problems: Hyperglycemia
MAUDE report 50369775 ↗MalfunctionAug 20, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50358375 ↗MalfunctionAug 20, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50355468 ↗MalfunctionAug 20, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50355444 ↗MalfunctionAug 20, 2026Failure to Charge
It was reported that the pump battery was charging slower than expected. 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 50355022 ↗MalfunctionAug 20, 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 50352895 ↗MalfunctionAug 20, 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 50348545 ↗MalfunctionAug 19, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50331499 ↗MalfunctionAug 19, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50331485 ↗MalfunctionAug 19, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50330898 ↗MalfunctionAug 19, 2026Incorrect Measurement
It was reported that the insulin gauge was inaccurate. There was no reported adverse impact to the customer. 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 50328480 ↗MalfunctionAug 19, 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 50327635 ↗MalfunctionAug 19, 2026Premature Discharge of Battery
It was reported that pump battery depleted rapidly and customer declined any troubleshooting. There was no reported impact to the customer¿s blood glucose level. Customer declined further support, no follow up was needed, and no additional information was received regarding the outcome of the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50327251 ↗InjuryAug 19, 2026Use of Device Problem
It was reported that customer received alert for incomplete cartridge change and experienced high blood glucose reading, with specific value unknown but displayed as ¿High.¿ Customer delivered correction bolus using pump, did not require third-party assistance, and was educated by Technical Support on meaning of alert and instructed to return to pump home screen and ensure pump screen was off before putting pump away to prevent accidental screen touches and incomplete alerts; customer understood and acknowledged instructions.
Patient problems: Hyperglycemia
MAUDE report 50325072 ↗MalfunctionAug 19, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50322739 ↗MalfunctionAug 17, 2026Key or Button Unresponsive/not Working
It was reported that the pump touch screen was unresponsive. There was no adverse impact to customer¿s blood glucose level. The customer reverted to manual injections for insulin therapy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50279644 ↗
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 1005011Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall3 deaths35,600 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.