Tandem MobiRecalls & reported problems across all models
Tandem Diabetes Care, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one Tandem Mobi model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 51,239
- Deaths reported
- 5
- Injuries reported
- 7,357
- Recalls
- 3
We found 7 models of Tandem Mobi by Tandem Diabetes Care, Inc. in the FDA's device registry (GUDID). Together they are named in 51,239 adverse event reports in the FDA's MAUDE database, received between Oct 25, 2023 and Sep 30, 2026 — classified as 5 deaths, 7,357 injuries, 43,877 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (25,381 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Tandem Mobi recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 6 of these models · Recall details · FDA record ↗
- Aug 5, 2025Open, Classified
A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may result in an unexpected automatic insulin correction bolus (autobolus ) which could result in hypoglycemia.
Z-0232-2026 · Root cause: Software change control · Recall details · FDA record ↗
- Feb 27, 2025Open, Classified
A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.
Z-1520-2025 · Root cause: Software Design Change · Recall details · FDA record ↗
Most reported Tandem Mobi problems
Device problems
- Pumping Stopped25,381
- Obstruction of Flow14,307
- Adverse Event Without Identified Device or Use Problem2,413
- Mechanical Problem2,374
- Charging Problem1,232
- Partial Blockage899
- Failure to Charge734
- Air/Gas in Device656
Patient problems
- No Clinical Signs, Symptoms or Conditions43,956
- Hyperglycemia6,179
- Hypoglycemia1,084
- Elevated Ketones/ Diabetic Ketoacidosis327
- Loss of consciousness58
- Insufficient Information56
- Vomiting35
- Nausea18
Tandem Mobi models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Tandem Mobi 1013655Alternate Controller Enabled Insulin Infusion Pump1 recall3 deaths29,532 reports
- Tandem Mobi, pump, Control-IQ 7.9 1014801Alternate Controller Enabled Insulin Infusion Pump2 recalls1 death7,327 reports
- Tandem Mobi 1013700Alternate Controller Enabled Insulin Infusion Pump1 recall1 death6,314 reports
- Tandem Mobi 1013656Alternate Controller Enabled Insulin Infusion Pump1 recall4,678 reports
- Tandem Mobi 1010750Alternate Controller Enabled Insulin Infusion Pump1 recall2,031 reports
- Tandem Mobi Starter Kit 1014081Alternate Controller Enabled Insulin Infusion Pump1 recall1,244 reports
- Tandem Mobi 1012719Alternate Controller Enabled Insulin Infusion Pump1 recall113 reports
Recent Tandem Mobi adverse event reports
The 15 most recent reports across all models, 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 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 ↗MalfunctionSep 30, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954998 ↗MalfunctionSep 30, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954991 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hypoglycemia
MAUDE report 50954604 ↗MalfunctionSep 30, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952680 ↗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, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951975 ↗MalfunctionSep 30, 2026Mechanical Problem
It was reported that a cartridge alarm occurred 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 50951724 ↗MalfunctionSep 30, 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 50951128 ↗MalfunctionSep 30, 2026Pumping Stopped
A malfunction was reported on the pump. There was no reported adverse impact to the customer. 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 50951120 ↗MalfunctionSep 30, 2026Failure to Charge
It was reported that Tandem Mobi battery would charge up to 95% but would not reach 100%. There was no adverse impact to the customer¿s blood glucose level. 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 50950707 ↗MalfunctionSep 30, 2026Pumping Stopped
A malfunction was reported on the pump. The customer¿s blood glucose (BG) level was 212 mg/dL. 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 50950704 ↗
Other Tandem Diabetes Care, Inc. products
- t:slim X2 Insulin Pump45 models · 897,233 reports · 4 recalls
- t:slim X2 Insulin Pump with Control-IQ11 models · 522,176 reports · 2 recalls
- t:slim X2 Insulin Pump with Basal-IQ14 models · 195,037 reports · 2 recalls
- t:slim X2 Insulin Pump with Control-IQ Technology11 models · 126,966 reports · 3 recalls
- t:slim X2 5.0 Insulin Pump5 models · 41,241 reports · 2 recalls
- t:slim X2 Insulin Pump2 models · 8,967 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered, combining the brand names used for this product line.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page