Tandem Mobi 1010750Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,031 adverse event reports that list this exact device (DI 00389152075013), received between Oct 25, 2023 and Sep 30, 2026 — classified as 257 injuries, 1,774 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (797 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. Oct 6, 2025Open, Classified

   Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue causing Malfunction 12: "Pump cannot operate, the mobile app can no longer receive data from the pump. Insulin delivery and any active CGM Sessions have been stopped", which could result in hyperglycemia.

   Z-0427-2026 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 2,031 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955172 ↗
• MalfunctionSep 29, 2026Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940844 ↗
• MalfunctionSep 29, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936858 ↗
• MalfunctionSep 29, 2026Obstruction of Flow

  It was reported that occlusion alarm occurred on Tandem Mobi pump, and caller noted second event about a month earlier while using infusion set, cartridge, and Novolog/NovoRapid insulin. There was no adverse impact to the customer¿s blood glucose level. Customer resolved issue by changing infusion set and cartridge, reloading cartridge, and resuming insulin delivery, and Technical Support advised customer to continue monitoring and to follow up if occlusion alarm recurred.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936523 ↗
• MalfunctionSep 29, 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 50933608 ↗
• MalfunctionSep 29, 2026Pumping Stopped

  It was reported that ongoing cartridge alarms occurred during insulin delivery. Customer reverted to an alternate method of insulin therapy. There was no adverse impact to the customer¿s blood glucose level.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927164 ↗
• MalfunctionSep 28, 2026Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925032 ↗
• MalfunctionSep 28, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922294 ↗
• MalfunctionSep 28, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922253 ↗
• MalfunctionSep 28, 2026Obstruction of Flow

  It was reported that customer experienced an occlusion alarm. There was no adverse impact to the customer¿s blood glucose level. Customer continued to use the pump for insulin therapy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915769 ↗
• MalfunctionSep 4, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600460 ↗
• MalfunctionAug 24, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50413035 ↗
• MalfunctionAug 20, 2026Pumping Stopped

  It was reported that Tandem Mobi showed cartridge alarm related to motor failure mode while pump was in use, and customer contacted support for assistance. There was no adverse impact to the customer¿s blood glucose level. Customer removed cartridge and delivered 9-unit bolus as instructed, then successfully loaded new cartridge, and issue was resolved with no further assistance needed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50347956 ↗
• MalfunctionAug 19, 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. 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 50326725 ↗
• MalfunctionAug 19, 2026Pumping Stopped

  It was reported that pump displayed software malfunction alarm code Malf 0, and caller contacted Technical Support for assistance. There was no adverse impact to the customer¿s blood glucose level. Customer worked with Technical Support to reset pump using provided instructions, malfunction did not recur after reset, customer was advised to continue using pump and to call back if any malfunction alarm appeared again, and caller acknowledged and understood instructions.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50322751 ↗
• InjuryAug 17, 2026Use of Incorrect Control/Treatment Settings

  It was reported that the customer experienced a low blood glucose (BG) level of 40 mg/dL. Reportedly, the customer's settings were entered incorrectly. Customer drank soda to address BG. Customer updated their pump settings to address the event.

  Patient problems: Hypoglycemia

  MAUDE report 50277924 ↗
• MalfunctionAug 6, 2026Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50162092 ↗
• MalfunctionJul 8, 2026Pumping Stopped

  IT WAS REPORTED THAT PUMP DISPLAYED MALFUNCTION ALARM CODE MALF 24 WITH FAULT ID 24-0X2219 AND COULD NOT BE RESET, AND THERE WERE NO NOTABLE EVENTS PRIOR TO THE MALFUNCTION. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER PLANNED TO USE MULTIPLE DAILY INJECTIONS AS BACKUP INSULIN THERAPY WHILE TANDEM TECHNICAL SUPPORT ARRANGED SHIPMENT OF REPLACEMENT PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25747709 ↗
• MalfunctionJul 7, 2026Pumping Stopped

  IT WAS REPORTED THAT PUMP DISPLAYED MALFUNCTION ALARM MALF 9 WITH NO NOTABLE EVENTS OCCURRING BEFOREHAND. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER CONTACTED TECHNICAL SUPPORT, WAS GUIDED THROUGH RESETTING PUMP USING PROVIDED INSTRUCTIONS, CONFIRMED THAT MALFUNCTION DID NOT RECUR AFTER RESET, AND WAS ADVISED TO CONTINUE USING PUMP AND CALL BACK IF ANY MALFUNCTION CODE APPEARED AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25732124 ↗
• MalfunctionJul 6, 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 25726879 ↗
• MalfunctionJul 2, 2026Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE WAKE BUTTON WAS NOT WORKING. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER. MULTIPLE ATTEMPTS WERE MADE BY TANDEM¿S TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25692987 ↗
• MalfunctionJul 2, 2026Pumping Stopped

  IT WAS REPORTED THAT PUMP DISPLAYED MALFUNCTION ALARM CODE 9 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 WITH RESETTING PUMP, CONFIRMED MALFUNCTION DID NOT RECUR, AND ADVISED CUSTOMER TO CONTINUE USING PUMP AND TO CALL BACK IF ANY MALFUNCTION ALARMS APPEARED AGAIN, WHICH CALLER ACKNOWLEDGED AND UNDERSTOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25690919 ↗
• MalfunctionJun 30, 2026Failure to Charge

  IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER. 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 25665881 ↗
• MalfunctionJun 29, 2026Pumping Stopped

  IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING INSULIN DELIVERY. CUSTOMER RELOADED THE 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 25659301 ↗
• 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. MULTIPLE CONTACT ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE ISSUE; HOWEVER, NO RESPONSE WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25654269 ↗