Tandem Mobi 1013656Recalls & reported problems
Tandem Diabetes Care, Inc. · Tandem Mobi Pump with Control-IQ, Replacement · Class 2
All models of Tandem Mobi (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Tandem Mobi is an insulin pump. Reports most often describe the pump stopping and blocked flow, and some describe charging problems. The device appears in 4,682 reports, with 592 injuries and no deaths. It has 1 open recall from October 2025 for a software issue that can falsely signal a motor failure and stop the pump working with its app. Reports dropped to 967 in the last 12 months from 3,520 before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 4,678
- Deaths reported
- 0
- Injuries reported
- 592
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4,678 adverse event reports that list this exact device (DI 00389152365619), received between Jun 27, 2024 and Sep 29, 2026 — classified as 592 injuries, 4,086 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (2,252 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 16, 2026.
Reports received per month
Recalls naming this device
- 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Pumping Stopped2,252
- Obstruction of Flow1,453
- Mechanical Problem303
- Adverse Event Without Identified Device or Use Problem180
- Charging Problem127
- Partial Blockage64
- Failure to Charge42
- Incorrect Measurement34
Patient problems
- No Clinical Signs, Symptoms or Conditions4,098
- Hyperglycemia505
- Hypoglycemia82
- Elevated Ketones/ Diabetic Ketoacidosis13
- Loss of consciousness6
- Bruise/Contusion4
- Fall3
- Insufficient Information3
Recent adverse event reports
The 25 most recent of 4,678 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941138 ↗MalfunctionSep 29, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938942 ↗MalfunctionSep 29, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938155 ↗MalfunctionSep 29, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937186 ↗MalfunctionSep 29, 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 50936554 ↗InjurySep 29, 2026Obstruction of Flow
It was reported that customer experienced occlusion alarms on Mobi pump. Customer¿s blood glucose (BG) level was reported as ¿High¿ during the event, with specific value unknown. Customer delivered a correction dose using pump to address BG level, then changed infusion set and cartridge, resumed insulin, and received education from Technical Support on proper cartridge use duration, with advice to monitor and seek further help if occlusion alarms occurred again.
Patient problems: Hyperglycemia
MAUDE report 50936223 ↗MalfunctionSep 29, 2026Obstruction of Flow
It was reported that customer experienced several occlusion alarms on Tandem Mobi pump over unspecified dates and was having repeated occlusion issues even after changing all supplies. There was no adverse impact to the customer¿s blood glucose level. Customer changed infusion set and cartridge and resumed insulin, and Technical Support arranged pump replacement; no additional information was received regarding the final outcome of the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935826 ↗InjurySep 29, 2026Obstruction of Flow
It was reported that multiple occlusion alarms occurred. Customer¿s blood glucose level was reported displayed as ¿High,¿ with specific value unknown. Customer delivered correction dose of insulin using pump, did not require outside medical assistance, and later resumed insulin therapy.
Patient problems: Hyperglycemia
MAUDE report 50933892 ↗MalfunctionSep 28, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925925 ↗MalfunctionSep 28, 2026Obstruction of Flow
It was reported intermittent occlusion alarms occurred back to back without the customer being able to resolve despite changing supplies. There was no reported adverse impact to the customer¿s blood glucose level. The customer continued to use the pump for insulin therapy with a backup plan if necessary.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920860 ↗MalfunctionSep 28, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920856 ↗MalfunctionSep 28, 2026Obstruction of Flow
It was reported that pump issued occlusion alarms over several days, and caller noted more than one occlusion event but CTS could not confirm specific alarm number in pump history. There was no adverse impact to the customer¿s blood glucose level. Customer changed soft cannula infusion set and cartridge, confirmed no visible issues with infusion set, and then resumed insulin therapy, and no additional information was received regarding the outcome of the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918266 ↗MalfunctionSep 8, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50672332 ↗MalfunctionSep 3, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50593377 ↗MalfunctionSep 3, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50589181 ↗MalfunctionAug 20, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50352820 ↗MalfunctionAug 19, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50332210 ↗MalfunctionJul 10, 2026Pumping Stopped
IT WAS REPORTED THAT PUMP DISPLAYED MALFUNCTION ALARM WITH CODE MALF 1, AND NO NOTABLE EVENTS OCCURRED BEFORE THE ISSUE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT PROVIDED PUMP RESET INSTRUCTIONS, ASSISTED CUSTOMER IN RESETTING PUMP, CONFIRMED MALFUNCTION DID NOT RECUR, ADVISED CUSTOMER TO CONTINUE USING PUMP, AND INSTRUCTED CUSTOMER TO CALL BACK IF ANY MALFUNCTION CODE RECURRED, WHICH CUSTOMER ACKNOWLEDGED AND UNDERSTOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25778057 ↗MalfunctionJul 9, 2026Inappropriate or Unexpected Reset
IT WAS REPORTED THAT AN UNEXPECTED PUMP RESET OCCURRED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER CONTINUED USING THE PUMP FOR INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25764340 ↗MalfunctionJul 8, 2026Use of Device Problem
IT WAS REPORTED THAT INSULIN GAUGE DISPLAYED AMOUNT DIFFERENT THAN EXPECTED BETWEEN PUMP AND MOBILE APP, WITH APP SHOWING LOWER FILL ESTIMATE THAN INSULIN ACTUALLY IN CARTRIDGE AND CALLER NOTICING GAP BETWEEN TOP OF CARTRIDGE AND INSULIN LEVEL. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER COMPLETED LOAD PROCESS, WAS ASSISTED WITH FILLING TUBING TO PUSH AIR OUT OF CARTRIDGE, WAS EDUCATED TO REMOVE GAPS AND AIR BUBBLES AND CONFIRM DROPS AT END OF TUBING WHEN FILLING, AND WAS INFORMED THAT SMALL DIFFERENCES BETWEEN DISPLAYED AND EXPECTED AMOUNTS WERE CONSIDERED ACCURATE, WHICH CUSTOMER UNDERSTOOD AND ACKNOWLEDGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25753802 ↗MalfunctionJul 8, 2026Charging Problem
IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO CHARGE THE PUMP USING THE TANDEM-PROVIDED USB CABLE, TANDEM CHARGING PAD AND TANDEM WALL ADAPTER. REPORTEDLY, THE CUSTOMER WAS ABLE TO SUCCESSFULLY CHARGE THE PUMP USING A NEW TANDEM WALL ADAPTER, CHARGING PAD AND USB CABLE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE VALUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25753777 ↗MalfunctionJul 8, 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 25749035 ↗InjuryJul 7, 2026Obstruction of Flow
IT WAS REPORTED THAT ONGOING INTERMITTENT OCCLUSION ALARMS OCCURRED. THE CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS DISPLAYED AS ¿HIGH¿; HOWEVER, A SPECIFIC VALUE WAS NOT PROVIDED. A CORRECTION BOLUS WAS DELIVERED TO ADDRESS BG LEVEL. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY AND HAS AN ALTERNATE METHOD OF INSULIN THERAPY AVAILABLE IF NECESSARY.
Patient problems: Hyperglycemia
MAUDE report 25734628 ↗MalfunctionJul 6, 2026Pumping Stopped
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. DURING TROUBLESHOOTING WITH TECHNICAL SUPPORT, THE PUMP WAS RESET CLEARING THE ALARM, AND INSULIN DELIVERY WAS RESUMED SUCCESSFULLY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25719467 ↗MalfunctionJul 6, 2026Pumping Stopped
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. DURING TROUBLESHOOTING WITH TECHNICAL SUPPORT, THE PUMP WAS RESET CLEARING THE ALARM, AND INSULIN DELIVERY WAS RESUMED SUCCESSFULLY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25718855 ↗
Other Alternate Controller Enabled Insulin Infusion Pump devices
- t:slim X2 Insulin Pump with Control-IQ 1006402Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump2 recalls18 deaths159,247 reports
- t:slim X2 Insulin Pump with Control-IQ 1006408Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump2 recalls12 deaths92,526 reports
- t:slim X2 Insulin Pump with Control-IQ 1009637Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall4 deaths83,884 reports
- Omnipod 5 Pod POD-BLE-H1-520Insulet Corporation · Alternate Controller Enabled Insulin Infusion Pump1 recall75 deaths71,459 reports
- Omnipod 5 Pod POD-OMNI-I1-6720Insulet Corporation · Alternate Controller Enabled Insulin Infusion Pump2 recalls11 deaths61,198 reports
- t:slim X2 Insulin Pump with Control-IQ 1009643Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall7 deaths51,110 reports
- t:slim X2 Insulin Pump with Control-IQ Technology 1013198Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall8 deaths47,637 reports
- t:slim X2 Insulin Pump with Control-IQ 1006404Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall18 deaths43,718 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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