Tandem Mobi, pump, Control-IQ 7.9 1014801Recalls & reported problems
Tandem Diabetes Care, Inc. · Tandem Mobi, pump, Control-IQ 7.x · Class 2
All models of Tandem Mobi (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Tandem Mobi insulin pump is worn to deliver insulin. Reports mostly describe pumps that stop, blocked flow and occlusion alarms, air in the device, and charging failures. There are 7,413 reports, including 1 death and 1,389 injuries. Two recalls are open, covering software defects that could cause unexpected insulin doses and incorrect glucose trend readings. Reports rose to 5,843 in the last 12 months from 1,570 in the 12 months 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
- 7,327
- Deaths reported
- 1
- Injuries reported
- 1,405
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 7,327 adverse event reports that list this exact device (DI 00389152480114), received between May 5, 2025 and Sep 30, 2026 — classified as 1 death, 1,405 injuries, 5,921 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (3,028 reports).
2 FDA recall records name this device's identifier, 2 still open.
1 other recall cover devices cleared under the same FDA submission (K241078); they may or may not involve this specific model.
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
- Aug 5, 2025Class IIOpen, 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, 2025Class IOpen, 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 problems
Device problems
- Pumping Stopped3,028
- Obstruction of Flow1,644
- Adverse Event Without Identified Device or Use Problem609
- Mechanical Problem386
- Air/Gas in Device296
- Failure to Charge269
- Priming Problem132
- Use of Device Problem131
Patient problems
- No Clinical Signs, Symptoms or Conditions5,926
- Hyperglycemia1,107
- Hypoglycemia282
- Elevated Ketones/ Diabetic Ketoacidosis79
- Loss of consciousness15
- Vomiting8
- Insufficient Information6
- Convulsion/Seizure5
Recent adverse event reports
The 25 most recent of 7,327 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954998 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hypoglycemia
MAUDE report 50954604 ↗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 ↗MalfunctionSep 30, 2026Break
It was reported that cartridge was damaged on two occasions, both occurring on same day. There was no adverse impact to the customer¿s blood glucose level. Customer¿s mother planned to call back after son left school to continue troubleshooting, and no additional information was received regarding the outcome of the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949865 ↗MalfunctionSep 30, 2026Data Problem
It was reported that graph in mobile app previously did not show readings in upper left corner after app reconnected with pump, although issue was not occurring at time of call and no error messages were seen. There was no adverse impact to the customer¿s blood glucose level. Customer was informed that app could take several minutes to reload pump information after connection was restored and was instructed to call back if pump information did not load within one hour, and no additional information was received regarding the outcome of the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949843 ↗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 50949791 ↗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 50949478 ↗MalfunctionSep 30, 2026Pumping Stopped
A malfunction was reported on the pump. There was no reported adverse impact to the customer's blood glucose level. Multiple contact attempts were made by Tandem Technical Support to obtain additional information regarding the issue; however, the customer did not respond. No additional patient or event information was available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948011 ↗MalfunctionSep 30, 2026Failure to Charge
It was reported that Tandem Mobi pump battery would not charge despite use of charging pad, cable, wall adapter, and confirmed working outlet, and pump battery had already been depleted. There was no adverse impact to the customer¿s blood glucose level, as customer relied on multiple daily injections for insulin since issue occurred. Customer tried different charging cable and charging pad without success, CTS arranged replacement charging supplies via two-day shipping, attempted multiple follow-up calls to confirm resolution, and ultimately closed case issue when no further contact was received from customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947700 ↗MalfunctionSep 30, 2026Failure to Charge
It was reported that Tandem Mobi pump battery would not charge even though customer used standard charging pad, cable, wall adapter, and confirmed wall outlet was working, and initial attempts including leaving pump on charging pad for 30 minutes did not resolve issue. There was no adverse impact to the customer¿s blood glucose level because pump was not actively set up. Customer tried different charging cable without success, then tried different charging pad which allowed pump to begin charging; customer ultimately continued using original charging supplies, and no further assistance was required.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946938 ↗MalfunctionSep 30, 2026Failure to Charge
It was reported that the pump battery could not be charged. There was no adverse impact to the customer's blood glucose. Reportedly, the pump successfully began charging after leaving the pump plugged into the power source.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946683 ↗MalfunctionSep 30, 2026Obstruction of Flow
It was reported that customer experienced intermittent occlusion alarms. There was no adverse impact to the customer¿s blood glucose level, and reported values did not exceed 500 mg/dL. Customer changed soft cannula infusion set and cartridge, resumed insulin therapy, and no issues were observed with infusion set; no additional information was received regarding any further outcome of event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946646 ↗MalfunctionSep 30, 2026Obstruction of Flow
It was reported that customer experienced an occlusion alarm. There was no adverse impact to the customer¿s blood glucose level. Customer resolved issue by changing infusion set and cartridge, resuming insulin, and no additional assistance was needed, so Technical Support planned to close case.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946644 ↗InjurySep 30, 2026Pumping Stopped
It was reported that pump displayed malfunction alarm Malf 24. The customer¿s blood glucose (BG) level was displayed as ¿High¿; however, a specific value was not provided. Customer gave correction insulin injection using manual injections, used manual injections as backup therapy, and did not require help from others. Technical Support provided instructions for storage mode and pump return, advised customer to enter pump settings and reconnect continuous glucose monitor to replacement pump, and arranged shipment of replacement pump under warranty.
Patient problems: Hyperglycemia
MAUDE report 50945064 ↗MalfunctionSep 29, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941260 ↗MalfunctionSep 29, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941259 ↗MalfunctionSep 29, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941249 ↗MalfunctionSep 29, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941135 ↗InjurySep 29, 2026Pumping Stopped
Patient problems: Hyperglycemia
MAUDE report 50941125 ↗MalfunctionSep 29, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941120 ↗MalfunctionSep 29, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941114 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K241078. One submission often covers many models, so check the product and lot details in each record.
- Z-0427-2026 · Oct 6, 2025 · Open, ClassifiedTandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a mo
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.
How reports and recalls are matched · Editorial policy · Report an error on this page