Pharmacy Kit, Starter Pack, Tandem Mobi, Control-IQ+ 1014936Recalls & reported problems
Tandem Diabetes Care, Inc. · Pharmacy Kit, Starter Pack, Tandem Mobi, Control-IQ+ · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Tandem Mobi starter kit with Control-IQ+ is an insulin pump that delivers insulin automatically. The 56 reports mostly describe the pump stopping or failing to pump insulin, blockages that stop insulin flow, and charging problems that left the pump unable to recharge; a few mention blood sugar running high or low after the pump stopped. Five injuries were reported and no deaths. There are no recalls naming this device.
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
- 47
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00389152493671), received between Jan 26, 2026 and Sep 30, 2026 — classified as 4 injuries, 43 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (19 reports).
3 other recalls 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
Most reported problems
Device problems
- Pumping Stopped19
- Obstruction of Flow7
- Mechanical Problem5
- Failure to Charge4
- Break3
- Adverse Event Without Identified Device or Use Problem2
- Charging Problem2
- Priming Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions43
- Hyperglycemia2
- Hypoglycemia2
- Fall1
- Laceration(s)1
Recent adverse event reports
The 25 most recent of 47 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 50955175 ↗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 50948789 ↗MalfunctionSep 30, 2026Charging Problem
It was reported that the customer was unable to charge the pump using the Tandem-provided USB charging cable, wall adapter and charging pad. There was no adverse impact to the customer's blood glucose level. Reportedly, the customer was able to successfully charge the pump with an alternate charging cable, charging pad and wall adapter.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948045 ↗MalfunctionSep 29, 2026Priming Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938220 ↗MalfunctionSep 29, 2026Pumping Stopped
It was reported that a cartridge alarm occurred during insulin delivery. There was no adverse impact to the customer¿s blood glucose value. Reportedly, the customer contacted the healthcare provider to obtain alternate insulin therapy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927076 ↗MalfunctionSep 28, 2026Pumping Stopped
A malfunction was reported on the pump. There was no reported adverse impact to the customer's blood glucose level. Customer later reset pump independently, confirmed through pump logs, and resumed insulin delivery, and Technical Support planned to continue scripted troubleshooting if customer called back again.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917085 ↗MalfunctionSep 8, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50672295 ↗MalfunctionAug 28, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50495104 ↗MalfunctionAug 20, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50357594 ↗MalfunctionAug 20, 2026Pumping Stopped
It was reported that pump displayed malfunction code Malf 0, and caller stated no other notable events occurred before malfunction. There was no adverse impact to the customer¿s blood glucose level. Customer contacted Technical Support, received instructions to reset pump, and successfully reset it, after which malfunction did not recur; pump remained in use and customer was advised to call back if malfunction appeared again.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50346562 ↗MalfunctionAug 20, 2026Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50345732 ↗MalfunctionAug 19, 2026Pumping Stopped
It was reported that a malfunction alarm occurred. The customer reverted to an alternate method of insulin therapy. There was no reported adverse impact to the customer's blood glucose level.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50327884 ↗MalfunctionAug 18, 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 adverse impact to the customer¿s blood glucose level.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50306383 ↗MalfunctionAug 17, 2026Break
It was reported that the cartridge was damaged at the t:lock, interrupting insulin delivery. Customer loaded a new cartridge to address the issue. There was no adverse impact to the customer's blood glucose level.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50276576 ↗MalfunctionAug 17, 2026Break
It was reported that the cartridge was damaged at the t:lock, interrupting insulin delivery. Customer loaded a new cartridge to address the issue. There was no adverse impact to the customer's blood glucose level.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50276575 ↗InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the customer experienced an elevated blood glucose (BG) level of 511 mg/dL; cause unknown. Customer administered a correction injection to address the BG. Recommendation was made to consult a healthcare provider in regards to diabetes management.
Patient problems: Hyperglycemia
MAUDE report 50159399 ↗MalfunctionJun 29, 2026Charging Problem
IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO CHARGE THE PUMP USING THE TANDEM-PROVIDED USB CHARGING CABLE. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER WAS ABLE TO SUCCESSFULLY CHARGE THE PUMP USING A SECONDARY USB CABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25649854 ↗MalfunctionJun 25, 2026Pumping Stopped
IT WAS REPORTED THAT PUMP DISPLAYED MALFUNCTION ALARM CODE 12 WITH NO NOTABLE EVENTS PRIOR TO THE ISSUE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER CONTACTED TECHNICAL SUPPORT, RECEIVED INSTRUCTIONS TO RESET PUMP, SUCCESSFULLY CLEARED MALFUNCTION WITHOUT RECURRENCE, WAS ADVISED TO CONTINUE USING PUMP, AND WAS INSTRUCTED TO CALL BACK IF MALFUNCTION ALARM OCCURRED AGAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25620919 ↗MalfunctionJun 23, 2026Obstruction of Flow
IT WAS REPORTED THAT ONGOING INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED PUMP SUPPLIES TO ADDRESS ISSUE. A SYSTEM CHECK WAS BEING PERFORMED BY TANDEM TECHNICAL SUPPORT, HOWEVER, THE CUSTOMER WASN¿T ABLE TO COMPLETE THE CHECK AT THE TIME OF REPORT. REPORTEDLY, THE CUSTOMER WOULD CHANGE THE INFUSION SET AND CARTRIDGE TO ADDRESS THE ISSUE. THERE WAS NO ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25596077 ↗MalfunctionJun 16, 2026Pumping Stopped
IT WAS REPORTED THAT PUMP DISPLAYED MALFUNCTION CODE WITH NO NOTABLE EVENTS OCCURRING BEFOREHAND. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER CONTACTED TECHNICAL SUPPORT, RECEIVED GUIDANCE TO RESET PUMP, SUCCESSFULLY CLEARED MALFUNCTION WITHOUT RECURRENCE, AND WAS ADVISED TO CONTINUE USING PUMP AND CALL BACK IF MALFUNCTION RETURNED, WHICH CUSTOMER ACKNOWLEDGED AND UNDERSTOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25523356 ↗MalfunctionJun 16, 2026Pumping Stopped
IT WAS REPORTED THAT PUMP DISPLAYED MALFUNCTION MESSAGE AFTER PUMP GOT WET WHEN CALLER WAS CAUGHT IN RAIN, AND CALLER INITIALLY COULD NOT ACCESS APP. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT PROVIDED PUMP RESET INFORMATION WHILE MALFUNCTION CLEARED OR PUMP RESET ITSELF DURING CALL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25516825 ↗MalfunctionJun 15, 2026Pumping Stopped
IT WAS REPORTED THAT PUMP DISPLAYED MALFUNCTION ALARM WITH MALFUNCTION CODE AND RELATED FAULT ID, AND THERE WERE NO NOTABLE EVENTS PRIOR TO THE ISSUE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER CONTACTED SUPPORT, RECEIVED INSTRUCTIONS TO RESET PUMP, SUCCESSFULLY CLEARED MALFUNCTION WITHOUT RECURRENCE, WAS ADVISED TO CONTINUE USING PUMP, AND WAS INSTRUCTED TO CALL BACK IF MALFUNCTION ALARM APPEARED AGAIN, WHICH CUSTOMER ACKNOWLEDGED AND UNDERSTOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25504303 ↗MalfunctionJun 12, 2026Pumping Stopped
IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING INSULIN DELIVERY. CUSTOMER RELOADED 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 25483346 ↗MalfunctionJun 11, 2026Obstruction of Flow
IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. CUSTOMER CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUE. THERE WAS NO ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25476467 ↗MalfunctionJun 4, 2026Obstruction of Flow
IT WAS REPORTED THAT ONGOING INTERMITTENT OCCLUSION ALARMS OCCURRED. THERE WAS NO ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL. ONGOING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT ULTIMATELY LED TO A PUMP REPLACEMENT. REPORTEDLY, 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 25394521 ↗
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
- Z-0232-2026 · Aug 5, 2025 · Open, Classifiedt:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor; Tandem Mobi insu
- Z-1520-2025 · Feb 27, 2025 · Open, ClassifiedTandem Mobi Insulin Pump with Interoperable Technology
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
- 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