Tandem Mobi 1012719Recalls & reported problems

Summary

The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 00389152271910), received between Dec 6, 2023 and Jul 31, 2026 — classified as 8 injuries, 105 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (52 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. Oct 6, 2025Class IOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 113 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Obstruction of Flow

  It was reported occlusion alarms occurred. The customer's blood glucose (BG) level was elevated frequently due to the alarms. Customer reports BG could be in the 370's, 380's and at times was displayed as "High"; a specific value was not provided, on the pump. Elevated blood glucose was addressed with a correction bolus via the pump. The customer changed supplies and resumed insulin therapy.

  Patient problems: Hyperglycemia

  MAUDE report 50098475 ↗
• MalfunctionJun 9, 2026Obstruction of Flow

  IT WAS REPORTED THAT ONGOING INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUE. THERE WAS NO ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25443485 ↗
• MalfunctionJun 8, 2026Mechanical Problem; Pumping Stopped

  IT WAS REPORTED THAT ONGING CARTRIDGE ALARMS OCCURRED DURING INSULIN DELIVERY AND DURING THE LOAD SEQUENCE. 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 25429097 ↗
• MalfunctionMay 1, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT UNSPECIFIED PUMP ISSUE OCCURRED. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. MULTIPLE ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, THE CUSTOMER DID NOT RESPOND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059238 ↗
• MalfunctionApr 28, 2026Pumping Stopped

  IT WAS REPORTED THAT PUMP DISPLAYED MALFUNCTION CODE 9 WITH ASSOCIATED FAULT ID BUT NO NOTABLE EVENTS OCCURRED BEFOREHAND. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT GUIDED CUSTOMER THROUGH PUMP RESET, CONFIRMED MALFUNCTION DID NOT RECUR, ADVISED CUSTOMER TO CONTINUE USING PUMP, AND INSTRUCTED CUSTOMER TO CALL BACK IF ISSUE RETURNED, WHICH CUSTOMER ACKNOWLEDGED AND UNDERSTOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015085 ↗
• MalfunctionApr 7, 2026Pumping Stopped

  IT WAS REPORTED THAT PUMP DISPLAYED MALFUNCTION CODE AND ISSUE RECURRED EVEN AFTER RESET. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT DECIDED TO SEND A REPLACEMENT PUMP. CUSTOMER WAS INSTRUCTED TO USE MULTIPLE DAILY INJECTIONS AS BACKUP THERAPY,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24799234 ↗
• MalfunctionApr 2, 2026Mechanical Problem

  IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING THE LOAD SEQUENCE. CUSTOMER REVERTED TO A BACKUP INSULIN PUMP FOR INSULIN THERAPY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772298 ↗
• MalfunctionMar 26, 2026Pumping Stopped

  A MALFUNCTION ALARM, IDENTIFIED AS "MALF 0," WAS REPORTED BY THE CUSTOMER. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER CONTACTED TECHNICAL SUPPORT, WHO PROVIDED INSTRUCTIONS ON RESETTING THE PUMP. AFTER THE RESET, THE MALFUNCTION DID NOT RECUR, AND THE CUSTOMER WAS ADVISED TO CONTINUE USING THE PUMP AND TO CALL BACK IF THE ISSUE REAPPEARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706217 ↗
• MalfunctionMar 2, 2026Obstruction of Flow

  IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED. THERE WAS NO ADVERSE IMPACT ON 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 24491360 ↗
• MalfunctionFeb 17, 2026Unexpected Shutdown

  IT WAS REPORTED THAT THE PUMP SHUT OFF UNEXPECTEDLY. 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 24365393 ↗
• MalfunctionFeb 12, 2026Mechanical Problem

  CALLER REPORTED A TANDEM MOBI CARTRIDGE ALARM DURING THE LOAD PROCESS. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CALLER WAS ABLE TO RELOAD THE ORIGINAL CARTRIDGE AND RESUME INSULIN THERAPY WITHOUT FURTHER ISSUES, RESOLVING THE MATTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328318 ↗
• InjuryFeb 11, 2026Pumping Stopped

  IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. THE CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS DISPLAYED AS ¿HIGH¿; HOWEVER, A SPECIFIC VALUE WAS NOT PROVIDED. A CORRECTION INJECTION WAS ADMINISTERED TO ADDRESS THE BG. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.

  Patient problems: Hyperglycemia

  MAUDE report 24318766 ↗
• MalfunctionFeb 6, 2026Mechanical Problem

  IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING THE LOAD SEQUENCE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. A REPLACEMENT PUMP WAS ARRANGED TO BE SENT TO THE CUSTOMER, WHO WILL CONTINUE USING THEIR CURRENT PUMP FOR BACKUP THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277219 ↗
• MalfunctionFeb 4, 2026Obstruction of Flow

  IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. REPORTEDLY, THE CUSTOMER HAD BEEN USING THE SAME CARTRIDGE AND INFUSION SET FOR OVER 3 DAYS ON THE MOBI PUMP. TANDEM CUSTOMER TECHNICAL SUPPORT INFORMED CUSTOMER THAT THE CARTRIDGE AND INFUSION IS INDICATED FOR USE WITH THE MOBI PUMP FOR 3 DAYS. CUSTOMER CHANGED CARTRIDGE AND INFUSION SET TO ADDRESS THE ISSUE. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24262028 ↗
• MalfunctionJan 16, 2026Obstruction of Flow

  IT WAS REPORTED THAT MULTIPLE INTERMITTENT OCCLUSION ALARMS OCCURRED. A CARTRIDGE CHANGE WAS PERFORMED RESOLVING THE OCCLUSION. THERE WAS NO ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24100408 ↗
• MalfunctionJan 16, 2026Obstruction of Flow

  IT WAS REPORTED THAT ONGOING INTERMITTENT OCCLUSION ALARMS OCCURRED. THERE WAS NO ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER REVERTED TO AN ALTERNATE METHOD INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24100400 ↗
• MalfunctionDec 12, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE WAKE BUTTON ON THE PUMP WAS NOT WORKING. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23788992 ↗
• MalfunctionNov 26, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PISTON ON THE PUMP WOULD GET STUCK WHILE DELIVERING INSULIN AND WOULD RETURN TO THE "DOWN" POSITION INTERMITTENTLY WITHOUT BEING PROMPTED TO DO SO. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER CONTACTED THE HEALTHCARE PROVIDER TO OBTAIN AN ALTERNATE METHOD OF INSULIN THERAPY UNTIL THE REPLACEMENT PUMP ARRIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657949 ↗
• MalfunctionNov 17, 2025Pumping Stopped; Pumping Stopped

  A MALFUNCTION WAS REPORTED WITH THE CUSTOMER'S PUMP, WHICH DISPLAYED A MALFUNCTION CODE MALF 13. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL, WITH NO REPORTS OF LEVELS EXCEEDING 500 MG/DL. 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 23572635 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ELEVATED BLOOD GLUCOSE (BG) LEVEL OF 595 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 23556786 ↗
• MalfunctionNov 5, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE PUMP SHUT OFF UNEXPECTEDLY. 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 23477132 ↗
• MalfunctionOct 30, 2025Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT INSULIN DRIPS WERE NOT OBSERVED TO BE EXITING THE INFUSION SET TUBING DURING THE LOAD FILL PROCESS. REPORTEDLY, A SUPPLY CHANGE WAS PERFORMED TO ADDRESS THE ISSUE AND INSULIN DELIVERY WAS RESUMED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23433163 ↗
• MalfunctionOct 15, 2025Pumping Stopped; Pumping Stopped

  A MALFUNCTION OCCURRED, AND IT WAS IDENTIFIED BY THE MALFUNCTION CODE 24. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER CONTACTED TECHNICAL SUPPORT, AND A REPLACEMENT PUMP WAS SENT AFTER THEY WERE INSTRUCTED ON HOW TO HANDLE THE CURRENT PUMP, INCLUDING PUTTING IT INTO STORAGE MODE AND RETURNING IT USING THE PROVIDED UPS RETURN BOX AND PRE-PAID LABEL. CUSTOMER WAS ADVISED ON THE PROCEDURES TO FOLLOW UPON RECEIVING THE NEW PUMP AND THE USE OF MULTIPLE DAILY INJECTIONS AS A BACKUP THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280906 ↗
• MalfunctionSep 19, 2025Pumping Stopped; Pumping Stopped

  A CUSTOMER REPORTED A TANDEM MOBI CARTRIDGE ALARM, WHICH OCCURRED DURING THE LOAD PROCESS DESPITE FOLLOWING THE MOBILE APP'S PROMPT TO REMOVE AND LOAD A NEW CARTRIDGE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL DID NOT EXCEED 500 MG/DL, INDICATING NO ADVERSE IMPACT ON THE BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT CONFIRMED THE CARTRIDGE ALARM AND DECIDED TO REPLACE THE PUMP. THE CUSTOMER REQUESTED A REPLACEMENT WITH A TSLIM PUMP AND EXPRESSED A DESIRE TO SPEAK WITH A HIGHER AUTHORITY; THEREFORE, THE CASE WAS TRANSFERRED TO CUSTOMER SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23097421 ↗
• MalfunctionSep 19, 2025Pumping Stopped; Pumping Stopped

  A TANDEM MOBI CARTRIDGE ALARM WAS REPORTED BY THE CALLER. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER WAS INSTRUCTED BY TECHNICAL SUPPORT TO RETURN THE PROBLEMATIC PUMP TO TANDEM USING THE PROVIDED RETURN BOX AND PRE-PAID LABEL. TECHNICAL SUPPORT SENT A REPLACEMENT PUMP AND PROVIDED NECESSARY INSTRUCTIONS, INCLUDING HOW TO PUT THE PUMP IN STORAGE MODE PRIOR TO ITS RETURN. THE CUSTOMER OPTED TO USE MANUAL DAILY INJECTIONS (MDI) AS A BACKUP THERAPY TO ENSURE CONTINUOUS INSULIN DELIVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23097206 ↗