Tandem Mobi Starter Kit 1014081Recalls & reported problems
Tandem Diabetes Care, Inc. · with Control-IQ 7.X · Class 2
All models of Tandem Mobi (7)
Data updated Oct 18, 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 insulin pump with Control-IQ delivers insulin for people with diabetes. Reports most often describe the pump stopping, blocked insulin flow, and some describe charging problems. The FDA database lists 1,252 reports, with 160 injuries and no deaths. One recall is open, from October 2025, over a software issue that can falsely signal vibration motor failure and make the pump stop working.
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
- 1,244
- Deaths reported
- 0
- Injuries reported
- 156
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1,244 adverse event reports that list this exact device (DI 00389152408170), received between Oct 28, 2024 and Sep 30, 2026 — classified as 156 injuries, 1,088 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (630 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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Pumping Stopped630
- Obstruction of Flow403
- Mechanical Problem45
- Adverse Event Without Identified Device or Use Problem40
- Charging Problem23
- Failure to Charge23
- Air/Gas in Device16
- Incorrect Measurement10
Patient problems
- No Clinical Signs, Symptoms or Conditions1,089
- Hyperglycemia132
- Hypoglycemia21
- Elevated Ketones/ Diabetic Ketoacidosis5
- Hip Fracture1
- Insufficient Information1
- Vomiting1
Recent adverse event reports
The 25 most recent of 1,244 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951975 ↗InjurySep 29, 2026Obstruction of Flow
It was reported that customer experienced frequent occlusion alarms over about one month, including alarms during meal and correction doses, which sometimes prevented insulin delivery and led to repeated attempts to clear alarms and resume insulin. Customer¿s blood glucose level reached high range with display reading ¿High,¿ but specific value was not provided. Customer gave correction insulin by injection, reloaded existing cartridge and infusion set, resumed insulin delivery, and worked with support for troubleshooting, after which pump replacement with updated software was recommended and arranged, and customer was instructed on storage, return of pump, and interim insulin therapy. 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 50935234 ↗MalfunctionSep 29, 2026Insufficient Flow or Under Infusion
A customer reported that their pump did not deliver the full extended bolus as expected, intending to deliver (b)(4) units with 50% over the next 25 minutes. There was no adverse impact to the customer¿s blood glucose level. Reportedly, customer continued to use pump for insulin therapy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933314 ↗MalfunctionSep 29, 2026Pumping Stopped
It was reported that pump displayed malfunction alarm code Malf 9 related to motor, and customer contacted Technical Support for assistance. There was no adverse impact to the customer¿s blood glucose level. Customer was assisted by Technical Support to reset pump, malfunction did not recur after reset, customer was advised to continue using pump and to call back if any malfunction alarm recurred, and customer acknowledged and understood instructions.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930610 ↗MalfunctionSep 29, 2026Pumping Stopped
It was reported that pump displayed malfunction alarm Malf 12, and caller requested assistance with resolving alarm. There was no adverse impact to the customer¿s blood glucose level. Customer contacted Technical Support, received instructions to reset pump, successfully reset malfunction alarm without recurrence, and was advised to continue using pump and call back if any malfunction alarms occurred again.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930605 ↗MalfunctionSep 29, 2026Pumping Stopped
It was reported that pump displayed malfunction alarm Malf 12 multiple times, with customer noting at least three occurrences on same pump. There was no adverse impact to the customer¿s blood glucose level. Customer continued to use current pump and planned to rely on alternate insulin method if necessary, while Technical Support arranged replacement pump with updated software, confirmed shipping details, provided instructions for placing pump into storage mode and returning problematic pump within 10 days, and advised customer to reprogram pump settings and reconnect CGM on replacement pump.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930602 ↗MalfunctionSep 28, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924149 ↗MalfunctionSep 28, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923371 ↗MalfunctionSep 28, 2026Pumping Stopped
It was reported that pump displayed malfunction alarm Malf 24 and could not be reset, indicating undertravel stall. There was no adverse impact to the customer¿s blood glucose level. Customer switched to insulin injections as backup therapy, and Technical Support arranged shipment of replacement pump, confirmed shipping details, provided instructions for storage mode and return of problematic pump within 10 days, and advised customer to program pump settings and reconnect continuous glucose monitor to replacement pump.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915771 ↗MalfunctionSep 28, 2026Pumping Stopped
It was reported that pump displayed malfunction alarm code 19 and was not able to be reset. There was no adverse impact to the customer¿s blood glucose level. Customer switched to insulin injections as backup therapy while Technical Support arranged for replacement pump, confirmed shipping details, provided instructions for storage mode and return of problematic pump within 10 days, and advised customer to enter pump settings and reconnect continuous glucose monitor to replacement pump.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913146 ↗MalfunctionSep 10, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721900 ↗MalfunctionSep 3, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50599984 ↗MalfunctionSep 3, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50597415 ↗MalfunctionAug 28, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50500461 ↗MalfunctionAug 20, 2026Mechanical Problem
It was reported that a cartridge alarm occurred during the load sequence. 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 50354210 ↗MalfunctionAug 20, 2026Pumping Stopped
It was reported that pump displayed malfunction alarm Malf 12, and caller contacted support to address issue. There was no adverse impact to the customer¿s blood glucose level. Customer was assisted with resetting pump, malfunction alarm did not recur after reset, customer was advised to continue using pump and to call back if any malfunction code recurred, and caller acknowledged and understood instructions.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50346035 ↗MalfunctionAug 20, 2026Pumping Stopped
It was reported that pump displayed malfunction alarm Malf 12, and caller contacted Technical Support for assistance. There was no adverse impact to the customer¿s blood glucose level. Technical Support provided pump reset instructions, assisted caller in resetting pump, confirmed malfunction alarm did not recur after reset, advised caller to continue using pump, and instructed caller to call back if any malfunction alarm recurred.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50345734 ↗MalfunctionAug 19, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50330121 ↗MalfunctionAug 17, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50278279 ↗MalfunctionAug 10, 2026Incorrect Measurement
It was reported that the insulin gauge was inaccurate and static. Customer continued to use the existing cartridge. There was no reported adverse impact to the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50192298 ↗MalfunctionAug 4, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50128836 ↗MalfunctionJul 27, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50038446 ↗MalfunctionJul 9, 2026Obstruction of Flow
IT WAS REPORTED THAT ONGOING OCCLUSION ALARMS OCCURRED. THERE WAS NO REPORTED ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25772834 ↗MalfunctionJul 9, 2026Obstruction of Flow
IT WAS REPORTED THAT ONGOING INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER¿S BLOOD GLUCOSE LEVEL REACHED 400 MG/DL ON (B)(6) 2026. THE ELEVATED BG WAS ADDRESSED BY A CORRECTION BOLUS VIA THE PUMP. NO THIRD PARTY ASSISTANCE WAS REQUIRED. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY AND HAS AN ALTERNATE METHOD OF INSULIN THERAPY AVAILABLE IF NECESSARY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25771073 ↗MalfunctionJul 7, 2026Mechanical Problem
IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING THE LOAD SEQUENCE. 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 25742707 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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