t:slim X2 Insulin Pump with Control-IQ+ Technology 1014071Recalls & reported problems
Tandem Diabetes Care, Inc. · Control-IQ+ 7.x, Medicare · 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 is an insulin pump with automated dosing software. Its 3,216 reports mostly describe the pump stopping, giving incorrect readings, or blocking insulin flow. The reports include 1 death and 687 injuries. There is 1 open recall, started in August 2025, over a software defect that may cause an unexpected insulin dose and low blood sugar. Reports rose sharply in the most recent year (2,732) from the year before (484).
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
- 3,154
- Deaths reported
- 2
- Injuries reported
- 691
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3,154 adverse event reports that list this exact device (DI 00389152407111), received between May 23, 2025 and Sep 30, 2026 — classified as 2 deaths, 691 injuries, 2,461 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (569 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
- Aug 5, 2025Class IIOpen, 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Incorrect Measurement569
- Pumping Stopped569
- Adverse Event Without Identified Device or Use Problem374
- Obstruction of Flow251
- Failure to Charge245
- Mechanical Problem147
- Charging Problem124
- Priming Problem96
Patient problems
- No Clinical Signs, Symptoms or Conditions2,467
- Hyperglycemia471
- Hypoglycemia213
- Elevated Ketones/ Diabetic Ketoacidosis37
- Loss of consciousness13
- Insufficient Information11
- Vomiting6
- Fall4
Recent adverse event reports
The 25 most recent of 3,154 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Pumping Stopped
A malfunction was reported on the pump. The customer¿s blood glucose (BG) level displayed as "High"; although a specific value was not provided. The customer had not addressed the elevated BG at the time of report. 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: Hyperglycemia
MAUDE report 50951147 ↗InjurySep 30, 2026Break
It was reported that pump displayed cartridge change error when customer tried to change cartridge and insulin, and customer¿s blood glucose level rose to a high value above 500 mg/dL. There was an adverse impact to the customer¿s blood glucose level, with the exact value unknown but displayed as ¿High.¿ Customer did not require assistance from any third party and followed guidance from Technical Support, who instructed inspection and cleaning of pump cartridge area, removal of loose O-ring, and reattachment of cartridge; customer then successfully completed cartridge loading process and resumed insulin delivery.
Patient problems: Hyperglycemia
MAUDE report 50950753 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
It was reported that pump touchscreen froze and was unresponsive. There was no adverse impact to the customer's blood glucose level. Multiple attempts were made by Tandem Technical Support to follow-up with the customer on the reported issue, but no response was received.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949510 ↗MalfunctionSep 30, 2026Loose or Intermittent Connection; Charging Problem
It was reported that the pump 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 value. Reportedly, customer continued using pump for insulin therapy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948811 ↗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's blood glucose level. 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 50948421 ↗InjurySep 30, 2026Excess Flow or Over-Infusion
It was reported that the customer inadvertently performed the load sequence while connected to the site. Customer's blood glucose (BG) level was displayed as ¿Low¿; however, a specific value was not provided. BG was addressed via consumption of carbohydrates. Tandem Technical Support educated the customer to not be connected to the pump during the fill tubing process.
Patient problems: Hypoglycemia
MAUDE report 50947742 ↗InjurySep 30, 2026Excess Flow or Over-Infusion
It was reported that the customer inadvertently performed the load sequence while connected to the site. The customer's blood glucose was 52 mg/dL. Reportedly, the customer required assistance to address BG level with carbohydrates. Tandem Technical Support educated the customer to not be connected to the pump during the fill tubing process.
Patient problems: Hypoglycemia
MAUDE report 50947740 ↗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. The customer reverted to an alternate method insulin therapy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947715 ↗MalfunctionSep 30, 2026Display or Visual Feedback Problem
It was reported that customer saw red vertical lines or bars on CGM graph, including a red line running from top to bottom of screen. There was no reported impact to the customer¿s blood glucose level. Multiple attempts were made by Tandem Technical Support to follow-up with the customer on the reported issue, but no response was received.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947683 ↗MalfunctionSep 30, 2026Charging Problem
It was reported that pump battery would not charge even when customer used Tandem charging cable, Tandem wall adapter, and working wall outlet, and issue did not resolve after leaving pump connected for at least 30 minutes; later customer found damage to charging cable and confirmed pump began charging after switching to different cable and wall adapter. There was no adverse impact to the customer¿s blood glucose level. Customer resolved issue by using non-Tandem charging cable with Tandem wall adapter, was informed that non-Tandem charging supplies were not recommended except for troubleshooting, acknowledged guidance, and was arranged to receive replacement charging supplies, with no pump shutdown and no further assistance required.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946976 ↗MalfunctionSep 30, 2026Incorrect Measurement
It was reported that the insulin gauge was inaccurate. There was no adverse impact to the customer's blood glucose level. Multiple attempts were made by Tandem Technical Support to follow-up with the customer on the reported issue, but no response was received.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946967 ↗MalfunctionSep 30, 2026Data Problem
It was reported that CGM graph was missing from pump home screen and unlock buttons appeared different, and caller noted pump had just come out of storage mode or experienced a reset for unknown reasons before issue was noticed. There was no reported impact to the customer¿s blood glucose level. Caller worked with Technical Support to continue troubleshooting unexpected shutdown or reset, and no additional information was received regarding the outcome of the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946663 ↗MalfunctionSep 30, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941488 ↗MalfunctionSep 30, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941481 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941479 ↗MalfunctionSep 29, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941305 ↗InjurySep 29, 2026Obstruction of Flow
Patient problems: Hyperglycemia
MAUDE report 50941251 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940338 ↗MalfunctionSep 29, 2026Break; Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940334 ↗MalfunctionSep 29, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939750 ↗MalfunctionSep 29, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938741 ↗MalfunctionSep 29, 2026Pumping Stopped; Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938563 ↗MalfunctionSep 29, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938533 ↗MalfunctionSep 29, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938210 ↗MalfunctionSep 29, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937915 ↗
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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