Tandem Mobi 1013655Recalls & reported problems
Tandem Diabetes Care, Inc. · Tandem Mobi Pump with Control-IQ · 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 is a Tandem Mobi insulin pump with Control-IQ. Its reports mostly describe pump stoppages, blocked flow, repeated occlusion and cartridge alarms, and malfunction codes. There are 29,601 reports, including 3 deaths and 3,893 injuries. One recall, started in October 2025, is open: a software issue can falsely flag a vibration motor failure and stop the pump from working. Reports dropped to 7,560 in the last 12 months, from 20,314 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
- 29,532
- Deaths reported
- 3
- Injuries reported
- 3,891
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 29,532 adverse event reports that list this exact device (DI 00389152365510), received between Jun 25, 2024 and Sep 30, 2026 — classified as 3 deaths, 3,891 injuries, 25,638 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (15,688 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 Stopped15,688
- Obstruction of Flow8,458
- Mechanical Problem1,290
- Adverse Event Without Identified Device or Use Problem1,128
- Charging Problem712
- Partial Blockage483
- Failure to Charge284
- Incorrect Measurement247
Patient problems
- No Clinical Signs, Symptoms or Conditions25,675
- Hyperglycemia3,340
- Hypoglycemia505
- Elevated Ketones/ Diabetic Ketoacidosis165
- Insufficient Information39
- Loss of consciousness24
- Vomiting19
- Nausea11
Recent adverse event reports
The 25 most recent of 29,532 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 50955098 ↗MalfunctionSep 30, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955097 ↗InjurySep 30, 2026Obstruction of Flow
Patient problems: Hyperglycemia
MAUDE report 50952487 ↗MalfunctionSep 30, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952008 ↗MalfunctionSep 30, 2026Failure to Charge
It was reported that Mobi pump battery would not charge and patient did not have pump available at the time, so troubleshooting could not be performed. There was no reported impact to the customer¿s blood glucose level. Customer agreed to call back with pump available so battery issue intake could be completed and assistance could be provided with setting up replacement pump, while CTS attempted follow-up by phone and left a message, then sent a follow-up email after no response and closed case with instructions to reopen if patient later contacted support to complete required intake.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949786 ↗MalfunctionSep 30, 2026Obstruction of Flow
It was reported that customer experienced repeated occlusion alarms on Tandem Mobi pump. There was no adverse impact to the customer¿s blood glucose level. Customer primed tubing, changed infusion set and cartridge, and was able to resume insulin, and later changed supplies again but continued to experience ongoing occlusion issues; CTS advised customer to monitor and seek additional help if alarms recurred, then arranged replacement pump with updated software, provided instructions for storage and return of problematic pump, and guided customer on setting up replacement pump and connecting continuous glucose monitor, while also following up by SMS to obtain supply information before closing case. 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 50949129 ↗MalfunctionSep 30, 2026Obstruction of Flow
It was reported that customer experienced repeated occlusion alarms on Mobi pump over several months, including active alarms that recurred during troubleshooting and were associated with supply changes, though customer did not report issues with infusion sites or insulin. There was no adverse impact to the customer¿s blood glucose level. Customer followed Technical Support instructions to disconnect tubing, adjust connections, and deliver test boluses, and clinical support recommended pump replacement; customer was advised to use multiple daily injections until replacement pump arrived, was given education on putting pump in storage mode and returning pump, and Tandem Technical Support proceeded with arranging replacement and follow-up.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948791 ↗MalfunctionSep 30, 2026Obstruction of Flow
It was reported intermittent occlusion alarms occurred. There was no reported adverse impact to the customer¿s blood glucose level. The customer changed supplies and resumed insulin therapy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946635 ↗MalfunctionSep 30, 2026Pumping Stopped
It was reported that pump displayed malfunction alarm Malf 24 for undertravel stall and could not be reset. There was no adverse impact to the customer¿s blood glucose level. Customer switched to multiple daily injections as backup insulin therapy, and Technical Support arranged shipment of replacement pump, confirmed shipping details, provided instructions to place problem pump into storage mode, and instructed customer to return problem pump within 10 days using provided return materials, then to enter pump settings and reconnect continuous glucose monitor on replacement pump.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941754 ↗MalfunctionSep 29, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941255 ↗MalfunctionSep 29, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941234 ↗MalfunctionSep 29, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941131 ↗MalfunctionSep 29, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941107 ↗MalfunctionSep 29, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940983 ↗InjurySep 29, 2026Obstruction of Flow
Patient problems: Hyperglycemia
MAUDE report 50940955 ↗MalfunctionSep 29, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940952 ↗MalfunctionSep 29, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940840 ↗MalfunctionSep 29, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940823 ↗MalfunctionSep 29, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939736 ↗MalfunctionSep 29, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938523 ↗MalfunctionSep 29, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938507 ↗MalfunctionSep 29, 2026Pumping Stopped
It was reported that pump displayed malfunction message and customer was not able to reset pump while away from home. There was no adverse impact to the customer¿s blood glucose level. Customer planned to call technical support again when at home to reset pump, and technical support attempted follow-up by phone but reached voicemail, and no additional information was received regarding the outcome of the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938457 ↗MalfunctionSep 29, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938450 ↗MalfunctionSep 29, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938240 ↗MalfunctionSep 29, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937872 ↗
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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