t:slim X2 Insulin Pump with Control-IQ+ Technology 1014070Recalls & reported problems

Summary

The FDA's MAUDE database contains 6,146 adverse event reports that list this exact device (DI 00389152407012), received between Apr 17, 2025 and Sep 30, 2026 — classified as 3 deaths, 1,083 injuries, 5,060 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (1,529 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. 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 ↗

2. Feb 27, 2025Class IOpen, Classified

   A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.

   Z-1519-2025 · Root cause: Software Design Change · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 6,146 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954995 ↗
• MalfunctionSep 30, 2026Failure to Charge

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952695 ↗
• MalfunctionSep 30, 2026Failure to Charge

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952488 ↗
• MalfunctionSep 30, 2026Failure to Charge

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952483 ↗
• MalfunctionSep 30, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952011 ↗
• MalfunctionSep 30, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951990 ↗
• InjurySep 30, 2026Use of Device Problem

  It was reported that the pump battery was depleting quickly resulting in the pump shutting off. Customer¿s blood glucose (BG) level was displayed as "High"; however, specific value was not provided. BG level was corrected with a bolus via the pump. Troubleshooting with Tandem Technical Support indicated that pump battery was depleting normally based on settings and customer usage. The customer continued to use the pump for insulin therapy.

  Patient problems: Hyperglycemia

  MAUDE report 50951981 ↗
• 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 50951124 ↗
• MalfunctionSep 30, 2026Pumping Stopped

  It was reported that an altitude alarm occurred. There was no reported impact to the customer's blood glucose. Reportedly, the cartridge was reloaded, and insulin delivery was resumed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950363 ↗
• 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 50949780 ↗
• 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 50949486 ↗
• MalfunctionSep 30, 2026Incorrect Measurement

  It was reported that pump insulin gauge displayed an amount different than expected and was currently showing a fill estimate of 0 units. There was no reported impact to the customer¿s blood glucose level. Customer was informed that fill estimate discrepancy was due to an alert or alarm condition, and no additional information was received regarding further actions or outcome of the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949166 ↗
• MalfunctionSep 30, 2026Incorrect Measurement

  It was reported that insulin gauge displayed an amount different than expected, and pump currently showed a positive fill estimate that did not match caller¿s calculation of remaining insulin. There was no adverse impact to the customer¿s blood glucose level. Customer worked with Technical Support, was educated that any positive value indicated at least that amount of insulin, disconnected from site and delivered a bolus to update insulin estimate, was advised not to overfill cartridge, and chose to continue using current cartridge and follow up if necessary.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948826 ↗
• MalfunctionSep 30, 2026Break

  It was reported that cartridge did not fully snap into pump, and caller noted o-ring from cartridge was stuck on pneumatic tap area. There was no reported impact to the customer¿s blood glucose level. Customer inspected pump and cartridge, removed o-ring from pneumatic tap, cleaned pneumatic area with alcohol wipe or lint-free cloth, and attempted to reload cartridge, but outcome of reload and any further actions were unknown because caller ended call before resuming insulin and no additional information was received regarding the outcome of the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948506 ↗
• MalfunctionSep 30, 2026Break

  It was reported that customer experienced two issues: cartridge did not fully snap into pump. There was no reported impact to the customer¿s blood glucose level. Customer inspected pump, found and removed cartridge O-ring from pneumatic area, successfully reloaded original cartridge, and resumed insulin therapy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948468 ↗
• 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 will use multiple daily injections (MDI) as a backup therapy until the replacement arrives.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948392 ↗
• MalfunctionSep 30, 2026Failure to Charge

  It was reported that pump battery would not charge despite using working outlets, original and alternate charging cables, and wall adapters, and pump did not recognize charging connection, although pump did not shut down and remained functional. 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 shipment of replacement pump, provided instructions for putting pump into storage mode and returning it within 10 days, and advised customer to program pump settings and reconnect continuous glucose monitor on replacement pump.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948103 ↗
• MalfunctionSep 30, 2026Incorrect Measurement

  It was reported that the insulin gauge was inaccurate. There was no reported adverse impact to the customer's blood glucose level. The customer re-loaded the cartridge to resolve the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947691 ↗
• 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, customer reverted to an alternate method of insulin therapy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947686 ↗
• MalfunctionSep 30, 2026Failure to Charge

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946974 ↗
• MalfunctionSep 30, 2026Display or Visual Feedback Problem

  It was reported that pump screen was dark and would not turn on despite multiple attempts to press button and connect to power, and pump showed red light and regular vibration indicating malfunction. 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 replacement pump, provided instructions for putting malfunctioning pump into storage mode and returning it, and advised customer to set up pump settings and connect glucose sensor on replacement pump.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946964 ↗
• InjurySep 30, 2026Obstruction of Flow

  It was reported intermittent occlusion alarms occurred. The customer's blood glucose level was displayed as "High"; a specific value was not provided. Elevated blood glucose was addressed with a correction bolus via the pump. The customer changed supplies and resumed insulin therapy. CTS provided education that cartridges should be changed every 48 hours with reported insulin, after which customer understood and case was closed.

  Patient problems: Hyperglycemia

  MAUDE report 50946922 ↗
• InjurySep 30, 2026Failure to Charge

  It was reported that the pump battery could not be charged intermittently which resulted in the pump shutting down. Customer's blood glucose (BG) level was displayed as ¿High¿; however, a specific value was not provided. Customer administered a manual insulin injection to address elevated BG. Reportedly, the pump successfully began charging after leaving the pump plugged into the power source.

  Patient problems: Hyperglycemia

  MAUDE report 50946660 ↗
• MalfunctionSep 30, 2026Failure to Charge

  It was reported that the pump battery could not be charged. There was no adverse impact to the customer's blood glucose. Reportedly, the pump successfully began charging after leaving the pump plugged into the power source.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946409 ↗
• MalfunctionSep 30, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946128 ↗