t:slim X2 Insulin Pump with Control-IQ+ Technology 1014073Recalls & reported problems
Tandem Diabetes Care, Inc. · Control-IQ+ 7.x, Refurbished · Class 2
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 15,187 adverse event reports, including 2 deaths and 2,306 injuries. Many describe the pump stopping, failing to charge or blocking flow, and reports often mention high or low blood sugar. There is 1 open recall, from August 2025, over a software issue that could cause an unexpected automatic insulin dose. Reports rose from 4,438 in the prior 12 months to 10,749 in the latest 12 months.
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
- 14,875
- Deaths reported
- 3
- Injuries reported
- 2,303
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 14,875 adverse event reports that list this exact device (DI 00389152407319), received between Mar 27, 2025 and Sep 30, 2026 — classified as 3 deaths, 2,303 injuries, 12,569 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (3,335 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
- Aug 5, 2025Open, Classified
A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may result in an unexpected automatic insulin correction bolus (autobolus ) which could result in hypoglycemia.
Z-0232-2026 · Root cause: Software change control · FDA record ↗
Most reported problems
Device problems
- Pumping Stopped3,335
- Failure to Charge1,920
- Incorrect Measurement1,381
- Charging Problem1,286
- Obstruction of Flow1,137
- Adverse Event Without Identified Device or Use Problem999
- Key or Button Unresponsive/not Working682
- Premature Discharge of Battery662
Patient problems
- No Clinical Signs, Symptoms or Conditions12,563
- Hyperglycemia1,615
- Hypoglycemia682
- Elevated Ketones/ Diabetic Ketoacidosis89
- Loss of consciousness36
- Insufficient Information25
- Fall7
- Vomiting7
Recent adverse event reports
The 25 most recent of 14,875 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955007 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955003 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954973 ↗MalfunctionSep 30, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954972 ↗InjurySep 30, 2026False Alarm
Patient problems: Hyperglycemia
MAUDE report 50954870 ↗InjurySep 30, 2026False Alarm
Patient problems: Hyperglycemia
MAUDE report 50954747 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954610 ↗MalfunctionSep 30, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954282 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954274 ↗MalfunctionSep 30, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953548 ↗MalfunctionSep 30, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952930 ↗MalfunctionSep 30, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952900 ↗MalfunctionSep 30, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952896 ↗MalfunctionSep 30, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952684 ↗InjurySep 30, 2026Pumping Stopped
Patient problems: Hyperglycemia
MAUDE report 50952677 ↗MalfunctionSep 30, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952516 ↗MalfunctionSep 30, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952515 ↗MalfunctionSep 30, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952508 ↗MalfunctionSep 30, 2026Failure to Charge
It was reported that the customer received a power source alert after plugging the pump into a wall outlet. There was no reported adverse impact to the customer. Reportedly, the alert cleared, and the pump successfully began charging after leaving the pump plugged into the power source.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952292 ↗MalfunctionSep 30, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952290 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952022 ↗MalfunctionSep 30, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952016 ↗MalfunctionSep 30, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952004 ↗MalfunctionSep 30, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951994 ↗MalfunctionSep 30, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951716 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.