t:slim X2 Insulin Pump with Control-IQ Technology 1013198Recalls & reported problems

Summary

The FDA's MAUDE database contains 47,637 adverse event reports that list this exact device (DI 00389152319810), received between Feb 2, 2024 and Sep 30, 2026 — classified as 8 deaths, 6,045 injuries, 41,584 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (17,037 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.

Recalls naming this device

1. 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 47,637 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955079 ↗
• MalfunctionSep 30, 2026False Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954978 ↗
• MalfunctionSep 30, 2026Failure to Pump

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954869 ↗
• MalfunctionSep 30, 2026False Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954864 ↗
• InjurySep 30, 2026Key or Button Unresponsive/not Working

  Patient problems: Hyperglycemia

  MAUDE report 50952482 ↗
• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951991 ↗
• MalfunctionSep 30, 2026Break

  It was reported that a cartridge did not fit onto the pump. Reportedly, there was an O-ring from a previous cartridge on the pneumatic tap. The customer removed the O-ring and successfully loaded the cartridge to address the event. There was no reported adverse impact to the customer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951711 ↗
• MalfunctionSep 30, 2026False Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951450 ↗
• InjurySep 30, 2026Break; Pumping Stopped; Charging Problem

  It was reported that the pump's USB port was damaged resulting in difficulties charging the pump leading to the pump shutting down. The customer's blood glucose (BG) level was "High", although a specific value was not given. The customer administered a correction bolus via pump to address BG level. The customer reverted to an alternate method insulin therapy.

  Patient problems: Hyperglycemia

  MAUDE report 50951185 ↗
• 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 50950697 ↗
• InjurySep 30, 2026False Alarm

  It was reported that pump repeatedly displayed altitude alarm and suspended insulin delivery over past month while within normal operating altitude. Customer¿s blood glucose level exceeded 500 mg/dL and meter displayed ¿High¿; specific value was unknown. Customer initially took no action for high blood glucose. Technical Support guided customer to clean speaker holes with soft brush and lint-free cloth, remove and reconnect cartridge, and wait for insulin to resume, after which insulin delivery restarted and altitude alarm did not recur. Pump resumed normal operation, insulin remained active, and customer received instructions on preventing future altitude alarms.

  Patient problems: Hyperglycemia

  MAUDE report 50950360 ↗
• MalfunctionSep 30, 2026Audible Prompt/Feedback Problem; Tactile Prompts/Feedback

  It was reported that pump speaker and vibration function were too quiet, and pump did not make sound when an alert was triggered. There was no reported impact to the customer¿s blood glucose level. The customer continued to use the current pump and will revert to an alternate insulin therapy if necessary.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950243 ↗
• 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 50949806 ↗
• MalfunctionSep 30, 2026Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949790 ↗
• MalfunctionSep 30, 2026Fitting Problem

  It was reported that customer sometimes could not get cartridge to snap into pump and had to use extra force to keep it in place. There was no reported impact to the customer¿s blood glucose level. Customer declined troubleshooting, and Technical Support created and closed case based on email, documented issue, and took no further action at that time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949507 ↗
• MalfunctionSep 30, 2026Pumping Stopped

  A malfunction was reported on the pump. There was no reported adverse impact to the customer. 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 50949481 ↗
• MalfunctionSep 30, 2026Loose or Intermittent Connection; Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949185 ↗
• MalfunctionSep 30, 2026Key or Button Unresponsive/not Working

  It was reported that the wake button on the pump was sticking. 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 50949176 ↗
• 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 customer was sent new charging supplies. No additional patient or event information was available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949168 ↗
• 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 50948868 ↗
• MalfunctionSep 30, 2026Failure to Charge; Pumping Stopped

  It was reported that the pump battery could not be charged which resulted in the pump shutting off. 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 50948851 ↗
• MalfunctionSep 30, 2026Key or Button Unresponsive/not Working

  It was reported that pump touchscreen was delayed in responding to touch inputs and required multiple touches to register interactions. There was no reported impact to the customer¿s blood glucose level. Customer declined follow-up, and no additional troubleshooting or corrective actions were completed by Technical Support.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948822 ↗
• InjurySep 30, 2026Pumping Stopped

  It was reported that the pump experienced a malfunction. The customer¿s blood glucose (BG) level displayed as "High"; although a specific value was not provided. A correction injection (MDI) was delivered to address the elevated BG level, and there was no need for third-party assistance. The pump was replaced to resolve the issue, and the customer continued to use the pump for insulin therapy and has an alternate method of insulin therapy available, if necessary, until the replacement arrives.

  Patient problems: Hyperglycemia

  MAUDE report 50948786 ↗
• MalfunctionSep 30, 2026Charging Problem

  It was reported that the customer was unable to charge the pump due to damage to the Tandem-provided USB charging cable. There was no reported adverse impact to the customer's blood glucose level. A new charging cable was sent to the customer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948490 ↗
• MalfunctionSep 30, 2026Key or Button Unresponsive/not Working

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948467 ↗