t:slim X2 Insulin Pump with Control-IQ Technology 1013196Recalls & 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 has 13,026 adverse event reports, including 8 deaths and 2,247 injuries. Many describe the pump stopping, giving incorrect measurements, or blocking flow, and reports often mention high or low blood sugar. There is 1 open recall, from July 2025, because some pumps built with certain speakers may fail, silencing alerts and stopping insulin delivery.
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
- 12,972
- Deaths reported
- 8
- Injuries reported
- 2,260
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 12,972 adverse event reports that list this exact device (DI 00389152319612), received between Jan 29, 2024 and Sep 30, 2026 — classified as 8 deaths, 2,260 injuries, 10,704 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (4,867 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 Stopped4,867
- Incorrect Measurement1,431
- Adverse Event Without Identified Device or Use Problem1,260
- Charging Problem805
- Obstruction of Flow651
- Filling Problem565
- Failure to Charge532
- Communication or Transmission Problem473
Patient problems
- No Clinical Signs, Symptoms or Conditions10,718
- Hyperglycemia1,567
- Hypoglycemia657
- Elevated Ketones/ Diabetic Ketoacidosis107
- Loss of consciousness42
- Insufficient Information34
- Fall19
- Confusion/ Disorientation10
Recent adverse event reports
The 25 most recent of 12,972 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952509 ↗MalfunctionSep 30, 2026Break; Loose or Intermittent Connection; Charging Problem
It was reported that the pump's USB port was loose, and the pump battery intermittently could not be charged properly without the customer maneuvering the cable into the charging port at a certain angle. There was no adverse impact to the customer¿s blood glucose level. The customer reverted to an alternate method insulin therapy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950728 ↗MalfunctionSep 30, 2026Incorrect Measurement
It was reported that the insulin gauge was inaccurate. Reportedly, the customer was not completing the air removal step during the load process. Tandem Technical Support educated customer regarding the air removal step. There was no reported impact to the customer¿s blood glucose level. Customer loaded a new cartridge to resolve the issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949868 ↗MalfunctionSep 30, 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 50949810 ↗MalfunctionSep 30, 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 50949491 ↗MalfunctionSep 30, 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 50949484 ↗MalfunctionSep 30, 2026Break
It was reported that cartridge did not fully snap into pump, and caller was concerned about cartridge fit. There was no reported impact to the customer¿s blood glucose level. Caller inspected pump and cartridge with guidance from Technical Support, confirmed no visible housing damage or debris, successfully loaded second cartridge onto pump, and resumed insulin delivery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948856 ↗MalfunctionSep 30, 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 50948429 ↗MalfunctionSep 30, 2026Premature Discharge of Battery; Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948407 ↗MalfunctionSep 30, 2026Pumping Stopped
It was reported that the pump experienced a malfunction. There was no reported adverse impact to the customer¿s blood glucose level. The pump was replaced to resolve the issue, and the customer continued to use the pump for insulin therapy and has an alternate method of insulin therapy available, if necessary, until the replacement arrives.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948396 ↗MalfunctionSep 30, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948067 ↗MalfunctionSep 30, 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. During troubleshooting with technical support, the pump was reset, and the customer continued to use the pump for insulin therapy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948047 ↗MalfunctionSep 30, 2026Charging Problem
It was reported that t:slim X2 pump battery would not charge unless caller held charging cable in place or positioned pump in specific way, and charging connection was unstable even though charging equipment and wall outlet were confirmed to be working. There was no adverse impact to the customer¿s blood glucose level. Customer changed charging cable and wall adapter, after which pump began charging normally, and no further assistance was required.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946971 ↗MalfunctionSep 30, 2026Failure to Charge
It was reported that pump battery would not charge even though customer used Tandem charging cable, Tandem wall adapter, and working wall outlet, and there was no power source alert in pump history. There was no adverse impact to the customer¿s blood glucose level. Customer left wall adapter plugged into working outlet for at least 30 minutes, after which pump began charging using original supplies, and no further assistance was required.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946934 ↗MalfunctionSep 30, 2026Obstruction of Flow
It was reported intermittent occlusion alarms occurred. There was no reported adverse impact to the customer¿s blood glucose level. The customer changed supplies and resumed insulin therapy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946917 ↗MalfunctionSep 30, 2026Pumping Stopped
It was reported that the pump stopped insulin delivery; cause was unknown. There was no adverse impact to the customer's blood glucose level. Tandem Technical Support assisted the customer with resuming insulin therapy successfully.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946134 ↗InjurySep 30, 2026Obstruction of Flow
It was reported that occlusion alarms occurred. The customer¿s blood glucose (BG) level was displayed as ¿High¿; however, a specific value was not provided. The elevated BG was addressed by a correction bolus via the pump. No third party assistance was required. Customer changed the pump supplies and resumed insulin delivery.
Patient problems: Hyperglycemia
MAUDE report 50941705 ↗InjurySep 29, 2026Pumping Stopped
Patient problems: Insufficient Information
MAUDE report 50941244 ↗InjurySep 29, 2026False Alarm
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 50941242 ↗MalfunctionSep 29, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941091 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50939731 ↗MalfunctionSep 29, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939675 ↗MalfunctionSep 29, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939038 ↗MalfunctionSep 29, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938753 ↗MalfunctionSep 29, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938559 ↗
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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