t:slim X2 Insulin Pump with Control-IQ Technology 1013197Recalls & reported problems
Tandem Diabetes Care, Inc. · Control-IQ 7.8 · 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 with Control-IQ technology delivers insulin. Its 4,453 adverse event reports mostly describe the pump stopping, recurring occlusion alarms, malfunction alarms and charging problems. The reports include 1 death and 590 injuries. The last 12 months had 1,175 reports, down from 2,098 in the 12 months before. 1 recall names this device: started in July 2025 and still open, it covers pumps with certain speakers that may stop insulin delivery and prevent audible alerts, which may lead to 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
- 4,448
- Deaths reported
- 1
- Injuries reported
- 588
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4,448 adverse event reports that list this exact device (DI 00389152319711), received between Feb 20, 2024 and Sep 30, 2026 — classified as 1 death, 588 injuries, 3,859 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (1,455 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 Stopped1,455
- Charging Problem455
- Incorrect Measurement418
- Battery Problem291
- Adverse Event Without Identified Device or Use Problem289
- Obstruction of Flow258
- Communication or Transmission Problem213
- Failure to Charge149
Patient problems
- No Clinical Signs, Symptoms or Conditions3,861
- Hyperglycemia436
- Hypoglycemia142
- Elevated Ketones/ Diabetic Ketoacidosis26
- Insufficient Information8
- Fall6
- Loss of consciousness5
- Vomiting4
Recent adverse event reports
The 25 most recent of 4,448 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954753 ↗MalfunctionSep 30, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952923 ↗MalfunctionSep 30, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952718 ↗MalfunctionSep 30, 2026Failure to Charge; Pumping Stopped
It was reported that pump battery did not charge despite use of confirmed working charging cable, wall adapter, and outlet, and later pump shut down and could not be turned back on even after trying different charging supplies, including supplies at daughter¿s house. There was no reported impact to the customer¿s blood glucose level. Customer planned to reach out to healthcare provider for backup insulin therapy, and Technical Support arranged shipment of replacement charging cable and wall adapter, discussed an out-of-warranty loaner pump option, and ultimately replaced pump and closed case.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951728 ↗MalfunctionSep 30, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951451 ↗MalfunctionSep 30, 2026Pumping Stopped
It was reported that multiple altitude alarms occurred. There was no reported impact to the customer's blood glucose. 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 50951179 ↗MalfunctionSep 30, 2026Fitting Problem
It was reported that patient experienced difficulty inserting and removing cartridges. There was no reported impact to the customer¿s blood glucose level. Customer declined further troubleshooting, and Technical Support documented event for record purposes only with no additional actions taken.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949516 ↗MalfunctionSep 30, 2026Failure to Charge
It was reported that t:slim X2 pump battery would not charge despite use of confirmed working wall outlets, Tandem charging cable, Tandem wall adapter, and attempts with different adapter and cable. There was no adverse impact to the customer¿s blood glucose level. Customer planned to use multiple daily injections as backup insulin therapy, and Technical Support arranged shipment of replacement pump with updated software, instructed customer to place problematic pump into storage mode, return it within 10 days using provided UPS materials, and advised customer to re-enter pump settings and reconnect CGM to replacement pump.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948090 ↗MalfunctionSep 30, 2026Pumping Stopped
It was reported that pump displayed malfunction alarms and patient¿s mother stated that no additional steps were taken in response to these alarms. There was no reported adverse impact to the customer. The customer declined follow up from Tandem Technical Support regarding the issue. No additional patient or event information was available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947720 ↗MalfunctionSep 30, 2026Display or Visual Feedback Problem
It was reported that pump screen was dark and would not turn on despite attempts to press button and charge pump, and pump showed blinking light but never completed start-up. There was no adverse impact to the customer¿s blood glucose level. Customer switched to insulin injections as backup therapy, and Technical Support arranged for replacement pump shipment, confirmed details for return of nonworking pump, and instructed customer to enter pump settings and reconnect continuous glucose monitor to replacement pump once received.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946941 ↗MalfunctionSep 29, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941307 ↗MalfunctionSep 29, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939769 ↗MalfunctionSep 29, 2026Audible Prompt/Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938750 ↗MalfunctionSep 29, 2026Failure to Charge; Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938516 ↗MalfunctionSep 29, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938251 ↗MalfunctionSep 29, 2026Scratched Material
It was reported that the pump touchscreen was scratched and 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 50934271 ↗MalfunctionSep 29, 2026Pumping Stopped
It was reported that pump displayed malfunction alarm Malf 12 and caller contacted Technical Support for assistance. There was no adverse impact to the customer¿s blood glucose level. Customer was guided through pump reset, malfunction alarm did not recur after reset, customer was advised to continue using pump and to call back if malfunction returned, and caller acknowledged and understood instructions.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931035 ↗InjurySep 28, 2026Priming Problem
Patient problems: Hyperglycemia
MAUDE report 50925930 ↗MalfunctionSep 28, 2026Mechanical Problem; Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924422 ↗MalfunctionSep 28, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924215 ↗MalfunctionSep 28, 2026Incorrect Measurement
It was reported that a minimum fill notification occurred after the user filled the cartridge with an unknown amount of insulin during the load sequence. There was no 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 50923967 ↗MalfunctionSep 28, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923644 ↗MalfunctionSep 28, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922245 ↗MalfunctionSep 28, 2026Failure to Charge
It was reported that t:slim X2 pump battery would not charge and customer saw power source alert with alert 07 in pump history when issue began. There was no adverse impact to the customer¿s blood glucose level. Customer continued using original charging supplies, issue resolved when pump began charging, and no further assistance was required from Technical Support.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918038 ↗MalfunctionSep 28, 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 50917147 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page