t:slim X2 Insulin Pump with Control-IQ Technology 1012868Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,317 adverse event reports that list this exact device (DI 00389152286815), received between Jan 4, 2024 and Sep 28, 2026 — classified as 196 injuries, 1,121 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (466 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 1,317 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Pumping Stopped

  Patient problems: Hyperglycemia

  MAUDE report 50923911 ↗
• MalfunctionSep 28, 2026Fracture

  It was reported that the pump touchscreen was cracked and unresponsive. There was no adverse impact to the customer's blood glucose level. Reportedly, the customer continued using the pump for insulin therapy until the replacement pump arrived.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923666 ↗
• MalfunctionSep 28, 2026Mechanical Problem

  It was reported that pump displayed a cartridge change error while customer was changing cartridge, but pump did not sound an alarm. There was no adverse impact to the customer¿s blood glucose level. Customer contacted support and was guided to inspect and clean pneumatic tap area, fill new cartridge, attach cartridge securely, and follow on-screen steps, after which customer successfully loaded cartridge and resumed insulin delivery, and no additional follow-up information was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916828 ↗
• InjuryAug 7, 2026Pumping Stopped

  It was reported that pump experienced malfunction alarm with code Malf 0, and customer¿s blood glucose reading showed ¿High¿ prior to correction. Customer¿s blood glucose level exceeded 500 mg/dL, specific value was unknown. Customer gave correction injection using multiple daily injections and did not require emergency assistance, then worked with Technical Support to reset pump, confirmed malfunction did not recur, and was instructed to continue using pump and call back if problem returned.

  Patient problems: Hyperglycemia

  MAUDE report 50177115 ↗
• MalfunctionAug 3, 2026Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50121662 ↗
• InjuryJul 9, 2026Pumping Stopped

  IT WAS REPORTED THAT PUMP EXPERIENCED MALFUNCTION ALARM. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS DISPLAYED AS "HIGH"; HOWEVER, SPECIFIC VALUE WAS NOT PROVIDED. ELEVATED BG WAS ADDRESSED BY CORRECTION INSULIN INJECTION AND DID NOT REQUIRE ASSISTANCE FROM A THIRD-PARTY. TECHNICAL SUPPORT CONFIRMED MALFUNCTION CODE WAS RESETTABLE, GUIDED CUSTOMER THROUGH PUMP RESET PROCESS, VERIFIED MALFUNCTION DID NOT RECUR AFTER RESET, ADVISED CUSTOMER THAT PUMP COULD CONTINUE TO BE USED, AND INSTRUCTED CUSTOMER TO CALL BACK IF MALFUNCTION ALARM APPEARED AGAIN.

  Patient problems: Hyperglycemia

  MAUDE report 25762488 ↗
• MalfunctionJul 7, 2026Obstruction of Flow

  IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER CHANGED INFUSION SET AND CARTRIDGE AND RESUMED INSULIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25735321 ↗
• MalfunctionJul 2, 2026Pumping Stopped

  IT WAS REPORTED THAT PUMP EXPERIENCED MALFUNCTION ALARM WITH NO NOTABLE EVENTS OCCURRING BEFOREHAND. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT PROVIDED PUMP RESET INSTRUCTIONS, ASSISTED CALLER IN RESETTING PUMP, CONFIRMED MALFUNCTION DID NOT RECUR, ADVISED CUSTOMER TO CONTINUE USING PUMP, AND INSTRUCTED CUSTOMER TO CALL BACK IF MALFUNCTION ALARM APPEARED AGAIN, WHICH CALLER ACKNOWLEDGED AND UNDERSTOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25691499 ↗
• MalfunctionJul 1, 2026Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT PUMP TOUCHSCREEN BECAME UNRESPONSIVE AND APPEARED FROZEN, PREVENTING CUSTOMER FROM INTERACTING WITH PUMP SCREEN. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER CONTACTED SUPPORT, RECEIVED INSTRUCTIONS TO PERFORM PUMP RESET, CHOSE TO RESET PUMP, AND WAS ABLE TO USE TOUCHSCREEN AGAIN AFTER RESET, AND ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25679998 ↗
• InjuryJun 29, 2026Obstruction of Flow

  IT WAS REPORTED ONGOING OCCLUSION ALARMS OCCURRED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 563 MG/DL. ELEVATED BLOOD GLUCOSE WAS ADDRESSED WITH A MANUAL DOSE INJECTION. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.

  Patient problems: Hyperglycemia

  MAUDE report 25659604 ↗
• MalfunctionJun 29, 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 25653962 ↗
• MalfunctionJun 26, 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 25642889 ↗
• MalfunctionJun 26, 2026Pumping Stopped

  IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING INSULIN DELIVERY. 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 25637905 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ELEVATED BLOOD GLUCOSE (BG) LEVEL OF 563 MG/DL. CAUSE WAS NOT KNOWN. A MANUAL INJECTION WAS DELIVERED TO ADDRESS BG. RECOMMENDATION WAS MADE TO CONSULT WITH A HEALTHCARE PROVIDER REGARDING DIABETES MANAGEMENT.

  Patient problems: Hyperglycemia

  MAUDE report 25636713 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY HOSPITALIZED IN THE INTENSIVE CARE UNIT WITH A BLOOD GLUCOSE (BG) LEVEL OF APPROXIMATELY 500 MG/DL WITH KETONES OF AN UNSPECIFIED SIZE ON 5/13/2026. CAUSE WAS NOT KNOWN. CUSTOMER WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN TO ADDRESS THE ELEVATED BG. CUSTOMER WAS DISCHARGED ON (B)(6) 2026 WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE.

  Patient problems: Hyperglycemia

  MAUDE report 25634440 ↗
• InjuryJun 23, 2026Use of Device Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN INCOMPLETE ALERT AS THEY HAD NOT COMPLETED A PUMP REQUEST. THE CUSTOMER THEN EXPERIENCED AN ELEVATED BLOOD GLUCOSE (BG) LEVEL THAT WAS DISPLAYED AS "HIGH", ALTHOUGH A SPECIFIC VALUE WAS NOT PROVIDED. THE CUSTOMER ADMINISTERED A BOLUS VIA THE PUMP TO ADDRESS THE BG AND CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. TANDEM TECHNICAL SUPPORT EDUCATED THE CUSTOMER ON THE MEANING OF AN INCOMPLETE ALERT.

  Patient problems: Hyperglycemia

  MAUDE report 25598378 ↗
• InjuryJun 22, 2026Obstruction of Flow

  IT WAS REPORTED THAT ONGOING INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS DISPLAYED AS "HIGH"; HOWEVER, SPECIFIC VALUE WAS NOT PROVIDED. ELEVATED BG WAS ADDRESSED BY A MANUAL INSULIN INJECTION.

  Patient problems: Hyperglycemia

  MAUDE report 25585977 ↗
• MalfunctionJun 17, 2026Pumping Stopped

  IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. DURING TROUBLESHOOTING WITH TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED, AND INSULIN DELIVERY WAS RESUMED SUCCESSFULLY. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25535328 ↗
• MalfunctionJun 15, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A CONTINUOUS GLUCOSE MONITOR ERROR 42. THE PUMP WAS RESET, AND THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25511527 ↗
• MalfunctionJun 15, 2026Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT AN UNEXPECTED RESET OCCURRED. THERE WAS NO REPORTED ADVERSE IMPACT TO 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 25509978 ↗
• MalfunctionJun 14, 2026Incorrect Measurement

  AN ONGOING ISSUE WAS REPORTED THAT THE INSULIN GAUGE WAS INTERMITTENTLY INACCURATE. CUSTOMER LOADED A NEW CARTRIDGE TO RESOLVE THE ISSUES. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25497710 ↗
• MalfunctionJun 12, 2026Pumping Stopped

  IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING INSULIN DELIVERY. 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 25488528 ↗
• MalfunctionJun 11, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25478752 ↗
• MalfunctionJun 11, 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 25473805 ↗
• InjuryJun 10, 2026False Alarm

  IT WAS REPORTED THAT PUMP DECLARED ALTITUDE ALARM AND CUSTOMER¿S BLOOD GLUCOSE ROSE TO A HIGH LEVEL, ALTHOUGH EXACT VALUE WAS UNKNOWN, WITH INSULIN DELIVERY SUSPENDED AND NO IMMEDIATE CORRECTIVE ACTION TAKEN BY CUSTOMER. CUSTOMER WORKED WITH TECHNICAL SUPPORT TO REMOVE AND CLEAN OBSTRUCTION FROM SPEAKER HOLES, RELOAD CARTRIDGE, AND ATTEMPT TO RESUME INSULIN, BUT ALTITUDE ALARM RECURRED, SO TECHNICAL SUPPORT INSTRUCTED CUSTOMER TO WAIT FOR MOISTURE TO EVAPORATE; WHEN ISSUE PERSISTED, PUMP AND CARTRIDGE WERE REPLACED, CUSTOMER WAS ADVISED TO USE MULTIPLE DAILY INJECTIONS AS BACKUP, AND WAS GIVEN INSTRUCTIONS FOR STORAGE MODE, PUMP RETURN, AND SETTING UP REPLACEMENT PUMP AND CONNECTED DEVICES.

  Patient problems: Hyperglycemia

  MAUDE report 25461124 ↗