t:slim X2 Insulin Pump with Control-IQ 1006402Recalls & reported problems
Tandem Diabetes Care, Inc. · t:slim X2 Insulin Pump with Control-IQ, 7.4.x · Class 2
2 open recalls name 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. Its reports mostly describe pump stoppages, battery trouble, unresponsive touchscreens and blocked insulin flow. There are 159,360 reports, including 18 deaths and 15,792 injuries. Two recalls are open: one covers speakers that may fail and stop insulin delivery, the other covers memory, battery display and touchscreen problems. Reports dropped to 6,311 in the last 12 months, from 22,854 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
- 159,247
- Deaths reported
- 18
- Injuries reported
- 15,789
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 159,247 adverse event reports that list this exact device (DI 00850006613762), received between Aug 10, 2020 and Sep 30, 2026 — classified as 18 deaths, 15,789 injuries, 143,440 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (48,284 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 Stopped48,284
- Incorrect Measurement16,029
- Charging Problem15,372
- Battery Problem12,479
- Obstruction of Flow9,768
- Adverse Event Without Identified Device or Use Problem9,358
- Communication or Transmission Problem8,288
- Failure to Sense7,613
Patient problems
- No Clinical Signs, Symptoms or Conditions141,245
- Hyperglycemia9,843
- Hypoglycemia5,437
- No Consequences Or Impact To Patient1,945
- Elevated Ketones/ Diabetic Ketoacidosis1,051
- Insufficient Information486
- No Known Impact Or Consequence To Patient326
- Loss of consciousness194
Recent adverse event reports
The 25 most recent of 159,247 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 50952723 ↗MalfunctionSep 30, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952494 ↗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 50951733 ↗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 50950719 ↗MalfunctionSep 30, 2026Charging Problem; Material Twisted/Bent
It was reported that the pump's USB port was damaged resulting in difficulties charging the pump. 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 50949822 ↗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 50949495 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
It was reported that the pump touch screen was unresponsive. 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 50948512 ↗MalfunctionSep 30, 2026Premature Discharge of Battery
It was reported that the pump battery was depleting quickly. 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 50948095 ↗MalfunctionSep 30, 2026Failure to Charge
It was reported that the customer was experiencing difficulty in charging the pump. 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 50947750 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
It was reported that the pump touch screen was unresponsive. 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 50947722 ↗MalfunctionSep 29, 2026Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938771 ↗MalfunctionSep 29, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938732 ↗MalfunctionSep 29, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938244 ↗MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937898 ↗MalfunctionSep 29, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937868 ↗MalfunctionSep 29, 2026Erratic or Intermittent Display
It was reported that the pump touch screen was timing off sooner than expected. 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 50936255 ↗MalfunctionSep 29, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935283 ↗MalfunctionSep 29, 2026Incorrect Measurement; Pumping Stopped
It was reported that the battery gauge was fluctuating resulting in the pump shutting down. There was no adverse impact to the customer¿s blood glucose value. Reportedly, customer reverted to an alternate method of insulin therapy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934631 ↗MalfunctionSep 29, 2026Incorrect Measurement
It was reported that the battery gauge was fluctuating. 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 50934278 ↗MalfunctionSep 29, 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 50933922 ↗MalfunctionSep 29, 2026Obstruction of Flow
It was reported that occlusion alarms occurred. 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 50930832 ↗MalfunctionSep 28, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923962 ↗MalfunctionSep 28, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923947 ↗MalfunctionSep 28, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923912 ↗MalfunctionSep 28, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923687 ↗
Other Alternate Controller Enabled Insulin Infusion Pump devices
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- 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
- 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.