t:slim X2 Insulin Pump with Control-IQ+ Technology 1014072Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,036 adverse event reports that list this exact device (DI 00389152407210), received between Apr 3, 2025 and Sep 30, 2026 — classified as 1 death, 177 injuries, 858 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (184 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.

Recalls naming this device

1. 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

Recent adverse event reports

The 25 most recent of 1,036 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Key or Button Unresponsive/not Working

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955008 ↗
• MalfunctionSep 30, 2026Failure to Charge

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952691 ↗
• MalfunctionSep 30, 2026False Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951435 ↗
• MalfunctionSep 30, 2026Loose 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 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 50951197 ↗
• MalfunctionSep 30, 2026Charging Problem

  It was reported that the customer was unable to charge the pump using the Tandem-provided USB charging cable. There was no reported adverse impact to the customer's blood glucose level. Reportedly, the customer was able to successfully charge the pump using a secondary USB cable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948855 ↗
• MalfunctionSep 30, 2026Incorrect Measurement

  It was reported that pump showed incorrect insulin amount in cartridge. There was no reported impact to the customer¿s blood glucose level. Customer declined further follow-up with Technical Support, was using pump that was out of warranty, and was in process of renewal, and no additional information was received regarding the outcome of the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948505 ↗
• 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 50948483 ↗
• MalfunctionSep 30, 2026Key or Button Unresponsive/not Working

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948474 ↗
• MalfunctionSep 30, 2026Display or Visual Feedback Problem

  It was reported that pump screen became unresponsive and was damaged excessively. There was no reported impact to the customer¿s blood glucose level. Customer declined further follow up with Technical Support, and no additional information was received regarding troubleshooting, corrective actions, or outcome of the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946670 ↗
• MalfunctionSep 29, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940833 ↗
• MalfunctionSep 29, 2026Unexpected Shutdown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938727 ↗
• MalfunctionSep 29, 2026Failure to Charge

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938576 ↗
• InjurySep 29, 2026Obstruction of Flow

  It was reported that customer experienced occlusion alarms. Customer¿s blood glucose was reported displayed as ¿High¿ on both dates, exceeding 500 mg/dL, with specific values unknown. Customer addressed high blood glucose by administering correction boluses via pump and did not require assistance from any third party. Customer resolved initial event by resuming insulin only and later changed infusion set and cartridge and resumed insulin, with no infusion set issues observed and cartridge not used for more than 48 hours, and customer declined further assistance while CTS closed case.

  Patient problems: Hyperglycemia

  MAUDE report 50936239 ↗
• MalfunctionSep 29, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935296 ↗
• MalfunctionSep 29, 2026Pumping Stopped

  It was reported that the pump experienced a malfunction. There was no reported adverse impact to the customer. The pump was replaced to resolve the issue, and the customer will use multiple daily injections (MDI) as a backup therapy until the replacement arrives.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935237 ↗
• MalfunctionSep 29, 2026False Alarm

  It was reported that an altitude alarm occurred. Reportedly, the pump was not outside the labeled altitude operating range. There was no reported impact to the customer's blood glucose level. The customer cleaned the pump speaker holes and resumed insulin therapy successfully.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933632 ↗
• MalfunctionSep 29, 2026Pumping Stopped

  It was reported that pump displayed malfunction alarm Malf 16, and no events occurred before malfunction. There was no adverse impact to the customer¿s blood glucose level. Customer planned to use multiple daily injections as backup insulin therapy, and Technical Support arranged replacement pump shipment, confirmed shipping details, instructed customer to place pump in storage mode, and advised customer to return malfunctioning pump within 10 days and to reenter pump settings and reconnect continuous glucose monitor on replacement pump.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931573 ↗
• MalfunctionSep 28, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924501 ↗
• MalfunctionSep 28, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924209 ↗
• MalfunctionSep 28, 2026Mechanical Problem

  It was reported that a cartridge alarm occurred during the load sequence. Customer loaded a new cartridge to resolve the issue. There was no adverse impact to the customer¿s blood glucose level.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923138 ↗
• MalfunctionSep 28, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922352 ↗
• MalfunctionSep 28, 2026Incorrect Measurement

  It was reported that the insulin gauge was inaccurate. There was no reported adverse impact to the customer. 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 50916536 ↗
• DeathSep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a customer had passed away on (b)(6) 2026. Their cause of death was reported as diabetic ketoacidosis which led to heart attack, and 40% blood flow. Healthcare provider noted that patient was out of remission from cancer and refused all treatment for all issues. The customer was wearing the pump at the time of death. A review of pump data will be performed, and the results will be submitted in a supplemental report.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Myocardial Infarction

  MAUDE report 50734126 ↗
• MalfunctionAug 21, 2026Pumping Stopped

  It was reported that pump screen went dark and would not turn on despite multiple attempts to press button and connect to power, pump showed red light and vibrations. There was no adverse impact to the customer¿s blood glucose level. Customer planned to use injections as backup insulin therapy, and Technical Support arranged for replacement pump with updated software, provided instructions for storage mode, confirmed shipping details, and instructed customer to return problematic pump within 10 days and to set up pump settings and continuous glucose monitor on replacement pump.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50367785 ↗
• MalfunctionAug 21, 2026Pumping Stopped

  It was reported that pump displayed malfunction alarm related to speaker, with no notable events occurring before issue. There was no adverse impact to the customer¿s blood glucose level. Customer contacted Technical Support, received instructions to reset pump, successfully cleared malfunction without recurrence, and was advised to continue using pump and call back if alarm recurred.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50366541 ↗