t:slim X2 Insulin Pump with Control-IQ Technology 1012867Recalls & 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 has 4,167 adverse event reports, including 464 injuries, 3,703 malfunctions and no deaths. The reports mostly describe the pump stopping, incorrect glucose readings, battery and charging problems, and repeated alarms, and some injury reports describe high blood sugar. There is 1 open recall, from July 2025, over speakers that may fail, so alerts go silent and insulin delivery can stop.
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
- 4,145
- Deaths reported
- 0
- Injuries reported
- 462
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4,145 adverse event reports that list this exact device (DI 00389152286716), received between Dec 28, 2023 and Sep 30, 2026 — classified as 462 injuries, 3,683 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (1,913 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 Stopped1,913
- Battery Problem390
- Incorrect Measurement308
- Charging Problem249
- Communication or Transmission Problem248
- Obstruction of Flow211
- Adverse Event Without Identified Device or Use Problem180
- Failure to Charge141
Patient problems
- No Clinical Signs, Symptoms or Conditions3,688
- Hyperglycemia373
- Hypoglycemia88
- Elevated Ketones/ Diabetic Ketoacidosis19
- Loss of consciousness8
- Insufficient Information7
- Nausea3
- Convulsion/Seizure2
Recent adverse event reports
The 25 most recent of 4,145 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951446 ↗MalfunctionSep 30, 2026False Alarm
It was reported that an altitude alarm occurred. Reportedly, the pump was not outside the labeled altitude operating range. There was no adverse impact to the customer's blood glucose level. The alarm ultimately cleared, and the customer continued to use the pump for insulin therapy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951204 ↗MalfunctionSep 30, 2026Premature Discharge of Battery
It was reported that pump battery depleted too quickly, although pump did not shut down, and customer used mobile app and was asked to upload pump data for battery use review. There was no reported impact to the customer¿s blood glucose level. Customer had not yet uploaded pump data, so Technical Support planned follow-up contact and sent follow-up email, with no additional information received regarding the outcome of the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949858 ↗MalfunctionSep 30, 2026Failure to Charge
It was reported that the pump battery could not be charged. There was no adverse impact to the customer's blood glucose. Reportedly, the pump successfully began charging after leaving the pump plugged into the power source.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948818 ↗MalfunctionSep 30, 2026Failure to Charge
It was reported that pump had difficulty charging and did not hold charge properly. There was no reported impact to the customer¿s blood glucose level. Customer contacted technical support, but battery issue was not further investigated and no additional information was received regarding the outcome of the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948494 ↗MalfunctionSep 29, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940824 ↗MalfunctionSep 29, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938945 ↗MalfunctionSep 29, 2026Pumping Stopped; Charging Problem; Material Twisted/Bent
It was reported that the pump's USB port was bent resulting in difficulties charging the pump, leading to the pump shutting off. 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 50934254 ↗MalfunctionSep 29, 2026Pumping Stopped
It was reported that pump displayed malfunction alarm code 12, with no notable events occurring before the alarm. There was no adverse impact to the customer¿s blood glucose level. Customer contacted Technical Support, received instructions on how to reset pump, successfully reset malfunction alarm without recurrence, and was advised to continue using pump and call back if alarm appeared again.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930830 ↗MalfunctionSep 28, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924432 ↗MalfunctionSep 28, 2026Pumping Stopped
It was reported that a cartridge alarm occurred during insulin delivery. Customer reverted to an alternate method of insulin therapy. There was no adverse impact to the customer¿s blood glucose level.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923659 ↗MalfunctionSep 28, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923107 ↗MalfunctionSep 28, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920854 ↗MalfunctionSep 28, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920844 ↗MalfunctionSep 28, 2026Failure to Charge
It was reported that t: slim X2 pump battery would not charge, and customer confirmed multiple power sources, charging cables, and wall adapters without resolving battery charging issue, though pump did not shut down and remained usable. There was no adverse impact to the customer¿s blood glucose level. Customer planned to continue using current pump and rely on alternate method if necessary, and Technical Support arranged replacement pump, confirmed shipping details, provided instructions for putting pump into storage mode, and advised customer to return problematic pump within 10 days and to set up pump settings and connect CGM on replacement pump.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918031 ↗MalfunctionSep 28, 2026Key or Button Unresponsive/not Working
It was reported that the wake button on the pump was difficult to press and required multiple presses in order to turn the pump screen on. 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 50917753 ↗MalfunctionSep 28, 2026Pumping Stopped
It was reported that pump displayed malfunction alarm for speaker and issue did not follow any notable event. There was no adverse impact to the customer¿s blood glucose level. Customer switched to multiple daily injections for insulin, and Technical Support arranged replacement pump with updated software, confirmed shipping details, instructed customer to place malfunctioning pump in storage mode and return it within 10 days, and advised customer to reprogram pump settings and reconnect continuous glucose monitor to replacement pump.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915093 ↗MalfunctionSep 1, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542245 ↗MalfunctionAug 26, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50458366 ↗MalfunctionAug 21, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50360188 ↗MalfunctionAug 20, 2026Mechanical Problem
It was reported that pump declared cartridge change error and customer initially had difficulty reloading cartridge while pump was in case. There was no adverse impact to the customer¿s blood glucose level. Customer removed case, confirmed cartridge seal was intact, successfully reloaded cartridge after seeing insulin drops, and resumed insulin delivery with guidance from Technical Support.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50356163 ↗MalfunctionAug 20, 2026Pumping Stopped
It was reported that pump displayed malfunction alarm with code Malf 0, and caller contacted technical support for assistance. There was no adverse impact to the customer¿s blood glucose level. Customer was guided by technical support to reset pump, malfunction did not recur after reset, customer was advised to continue using pump and to call back if alarm occurred again, and caller acknowledged instructions.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50350768 ↗MalfunctionAug 20, 2026Charging Problem; Material Twisted/Bent
It was reported that pump housing and USB port were damaged, which prevented charging and caused pump to shut down. There was no adverse impact to the customer¿s blood glucose level. Customer continued to use current pump and planned to use alternate method if needed, while Technical Support arranged shipment of replacement pump with updated software, confirmed shipping details, instructed customer to let battery fully deplete, and advised customer to return damaged pump within 10 days and to enter pump settings and reconnect continuous glucose monitor to replacement pump.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50350355 ↗MalfunctionAug 20, 2026Pumping Stopped
It was reported that a malfunction alarm occurred. The customer will continue to use the current pump 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 50347944 ↗MalfunctionAug 20, 2026Break
It was reported that cartridge did not fully snap into pump, and caller noticed cartridge ring stuck on pump connection area. There was no adverse impact to the customer¿s blood glucose level. Caller removed misplaced ring, checked cartridge for damage, reloaded same cartridge using load menu, and resumed insulin therapy successfully with guidance from Technical Support.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50347087 ↗
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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