t:slim X2 Insulin Pump with Control-IQ Technology 1013195Recalls & reported problems

Summary

The FDA's MAUDE database contains 30,344 adverse event reports that list this exact device (DI 00389152319513), received between Jan 19, 2024 and Sep 30, 2026 — classified as 7 deaths, 3,633 injuries, 26,704 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (14,004 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. Jul 21, 2025Class IOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30,344 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026False Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954981 ↗
• MalfunctionSep 30, 2026Key or Button Unresponsive/not Working

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954278 ↗
• MalfunctionSep 30, 2026Failure to Charge

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952295 ↗
• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952287 ↗
• InjurySep 30, 2026False Alarm

  It was reported that multiple altitude alarms occurred. Reportedly, the pump was not outside the labeled altitude operating range. The customer experienced an elevated blood glucose (BG) level displayed as "High"; although a specific BG value was not provided. Customer delivered a correction bolus via the pump to address the BG. Customer reverted to an alternate method of insulin therapy.

  Patient problems: Hyperglycemia

  MAUDE report 50951719 ↗
• MalfunctionSep 30, 2026Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951453 ↗
• 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 50950716 ↗
• 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. A correction injection (MDI) was delivered to address the elevated BG level, and there was no need for third-party assistance. 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 50950713 ↗
• MalfunctionSep 30, 2026Unexpected Shutdown

  It was reported that the pump shut off unexpectedly. There was no reported impact to the customer's blood glucose level. Reportedly, the customer continued to use the pump for insulin therapy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950208 ↗
• MalfunctionSep 30, 2026Pumping Stopped

  It was reported that malfunction alarm Malf 12 occurred on pump, with no notable events prior to the issue. There was no reported impact to the customer¿s blood glucose level. Customer planned to continue using current pump and rely on alternate method if needed until replacement arrived; Technical Support confirmed pump warranty and shipping details, instructed customer to place pump into storage mode and return pump within 10 days using provided packaging, and advised customer to reenter pump settings and reconnect continuous glucose monitor on replacement pump, while sending replacement pump to customer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950151 ↗
• MalfunctionSep 30, 2026Pumping Stopped

  It was reported that a malfunction alarm occurred. 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 with updated software, confirmed shipping details, provided instructions for putting pump into storage mode, and instructed customer to return problematic pump within 10 days and to program pump settings and reconnect continuous glucose monitor on replacement pump.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950145 ↗
• MalfunctionSep 30, 2026Key or Button Unresponsive/not Working

  It was reported that pump wake button did not function as expected, and customer experienced extreme difficulty turning on pump screen, often needing multiple presses. There was no adverse impact to the customer¿s blood glucose level. Customer switched to multiple daily injections as backup insulin therapy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949875 ↗
• MalfunctionSep 30, 2026Break; Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949869 ↗
• 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 50949861 ↗
• MalfunctionSep 30, 2026Mechanical Problem

  It was reported that pump displayed cartridge change error and caller was initially unable to load new cartridge despite following cleaning and loading instructions. There was no adverse impact to the customer¿s blood glucose level. Caller later successfully completed load process and chose to use back up pump temporarily before resuming insulin delivery on current pump, with assistance and guidance provided by Technical Support.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949838 ↗
• 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 50949816 ↗
• 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 50949813 ↗
• 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 50949500 ↗
• 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 50949479 ↗
• 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 50949473 ↗
• MalfunctionSep 30, 2026Incorrect Measurement

  It was reported that pump insulin gauge displayed 0 units instead of caller¿s expected 200 units, and caller was currently experiencing fill estimate issue even though load process and cartridge preparation steps had been completed correctly. There was no reported impact to the customer¿s blood glucose level. Caller was able to reload same cartridge with assistance from Technical Support, declined suggested test bolus, and was advised to monitor pump and follow up if necessary, with no additional information received regarding outcome of event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949156 ↗
• MalfunctionSep 30, 2026Battery Problem

  It was reported that pump battery stayed at 100% for 1 day and issue continued even after pump was reset. 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 50949153 ↗
• MalfunctionSep 30, 2026Incorrect Measurement

  It was reported that insulin gauge displayed a much lower amount than expected, with pump showing 14 units instead of caller¿s expected 200 units, and caller was currently experiencing this fill estimate issue despite having followed recommended steps for filling cartridge. There was no reported impact to the customer¿s blood glucose level. Caller declined to load new cartridge, chose to continue using current cartridge and follow up if necessary, and Technical Support arranged shipment of replacement cartridges and infusion sets as requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948867 ↗
• MalfunctionSep 30, 2026Key or Button Unresponsive/not Working

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948464 ↗
• MalfunctionSep 30, 2026Failure to Charge

  It was reported that pump battery would not charge and charging connection was not recognized despite using working outlets, different wall adapters, and different charging cables, though pump did not shut down and could still be turned on. There was no adverse impact to the customer¿s blood glucose level. Customer planned to use insulin injections as backup therapy while Tandem Technical Support arranged and sent replacement pump, instructed customer to allow pump battery to fully deplete, return problematic pump within 10 days using provided materials, and then set up pump settings and connect continuous glucose monitor on replacement pump.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948426 ↗