Omnipod 5 Controller APPRecalls & reported problems across all models

We found 4 models of Omnipod 5 Controller APP by Insulet Corporation in the FDA's device registry (GUDID). Together they are named in 99 adverse event reports in the FDA's MAUDE database, received between Oct 12, 2022 and Aug 7, 2026 — classified as 51 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (16 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

Omnipod 5 Controller APP 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.

1. Sep 11, 2025Open, Classified

   The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. This causes the single digit number to duplicate. This could result in errors in manual entry of digits - examples: bolus entry, I:C ratio, bolus calculator, prior to starting the bolus insulin delivery. Therefore, this may result in over delivery of insulin which may cause hypoglycemia.

   Z-0132-2026 · Root cause: Software design · Recall details · FDA record ↗

2. May 23, 2025Open, Classified

   Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if the user manually updates their phone settings to a region OUS that uses a decimal separator instead of a period decimal separator or chooses that format as a preference. Use of the affected software may result in over delivery of insulin by increasing the amount of insulin when a decimal separator is not recognized (e.g., 0.1 unit recognized as 1 unit) and thus may result in hypoglycemia, potentially severe.

   Z-2016-2025 · Root cause: Software design · Recall details · FDA record ↗

3. Feb 28, 2023Open, Classified

   An error message was received when using the Omnipod 5 App on compatible smartphones that prevented phone control users from controlling the Omnipod 5 Automated Insulin Delivery System from their Omnipod 5 App which may cause a delay in therapy. To reduce the volume of inquiries Insulet was receiving from customers, an email was sent to all phone control users and the cause of the error message was resolved by reverting to prior certificates on the Insulet cloud to secure communications between the Omnipod 5 App sotware and the Insulet Cloud. This issue was limited to only certain compatible Android smartphones and did not affect the Omnipod 5 Pods or the dedicated locked-down Controller provided by Insulet. All other Omnipod 5 users were still able to manage their insulin with the device without use of the smartphone app and affected users were able to switch to the locked-down control provided to all users when they initiated the device during the time the App was unavailable to them. Further, the Omnipod itself continued to deliver insulin as per its pre-programmed settings so although affected users who did not have the locked-down controller readily available may not have been able to command insulin boluses during this time, they continued to receive basal insulin without interruption. Lastly, users of the Omnipod 5 were advised during training to always have backup supplies ready in the event of a device malfunction which would include alternative means to deliver insulin subcutaneously until the issue is resolved to minimize disruption to their insulin regimen. There were 2,168 complaints received out of 7,838 users with the Android compatible smartphones affected and 9 MDRs were submitted, however, there were no serious injuries reported or reports of erroneous results as the primary issue was a delay in therapy. This defect cannot cause false results that could negatively impact patients.

   Z-2618-2023 · Root cause: Software Design Change · Recall details · FDA record ↗

Most reported Omnipod 5 Controller APP problems

Omnipod 5 Controller APP models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Omnipod 5 Controller APP 1.0

  Alternate Controller Enabled Insulin Infusion Pump
  1 recall48 reports
• Omnipod 5 Controller APP M009-2S-AP

  Continuous Glucose Monitor Informed Insulin Dose Calculator
  1 recall20 reports
• Omnipod 5 Controller APP M009-S-AP

  Continuous Glucose Monitor Informed Insulin Dose Calculator
  1 recall15 reports
• Omnipod 5 Controller APP M009-3P-AP

  Alternate Controller Enabled Insulin Infusion Pump
  16 reports

Recent Omnipod 5 Controller APP adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Use of Device Problem

  It was reported that the patient went to the emergency room (ER) with hyperglycemia on (b)(6)2026. The patient's blood glucose levels reached over 500 mg/dL while wearing the Pod between 4 and 24 hours. The Pod was worn on the arm. The patient reported having lost the phone where the Omnipod 5 application was manged, which contributed to the elevated blood glucose. Symptoms reported include confusion. The patient was treated with insulin. The patient was discharged the same day. The Pod was removed at the hospital so that the patient could get a magnetic resonance imaging (MRI).

  Patient problems: Cognitive Changes; Hyperglycemia

  MAUDE report 50178156 ↗
• InjuryAug 4, 2026Use of Incorrect Control/Treatment Settings

  It was reported that the patient visited the emergency room with hypoglycemia on (b)(6) 2026. The patient's blood glucose levels declined to 50 mg/dL while wearing the Pod(leg). The patient stated that they had transferred Omnipod 5 therapy settings to a new phone application and may have entered settings incorrectly during the phone change, which resulted in receiving more insulin than expected. Symptoms reported include malaise and fainting. The patient was treated with Intravenous (IV) fluids and was released the same day. The Pod was discarded.

  Patient problems: Hypoglycemia; Malaise; Syncope/Fainting

  MAUDE report 50135553 ↗
• MalfunctionJun 26, 2026Failure to Deliver

  IT WAS REPORTED THAT THE PATIENT¿S OMNIPOD SYSTEM WAS NOT ADMINISTERING BOLUS INSULIN. THE PATIENT CONTACTED INSULET CUSTOMER SUPPORT REGARDING A RECURRING ISSUE WITH HER INSULIN POD WHERE, EVERY NIGHT BETWEEN 6:00 PM AND 8:30 PM, HER BLOOD GLUCOSE LEVELS CLIMB TO 180 AND THEN PLATEAU BETWEEN 230-250 MG/DL. DESPITE THE SYSTEM CALCULATING CORRECTION DOSES CORRECTLY, IT ONLY DISPLAYS THE CORRECTION INSULIN AS "INSULIN ON BOARD" WITHOUT ACTUALLY ADMINISTERING INSULIN. THE INSULIN IS ONLY DELIVERED WHEN SHE ENTERS CARBOHYDRATE INTAKE, EVEN IF SHE HASN'T EATEN. THE PATIENT WAS INSTRUCTED TO REVIEW SETTINGS WITH THEIR HEALTHCARE PROVIDER, TO ENSURE SETTINGS ARE SUFFICIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25637801 ↗
• MalfunctionJun 26, 2026Failure to Deliver

  THE PATIENT REPORTED THAT THE SYSTEM WAS NOT DELIVERING BOLUS INSULIN, AFTER WEARING THE POD FOR APPROXIMATELY TWO DAYS. BLOOD GLUCOSE LEVELS WERE NOT PROVIDED, BUT PATIENT NOTED THAT THEY "WENT HIGH" AS A RESULT OF THIS EVENT. MEDICAL TREATMENT WAS NOT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25633766 ↗
• MalfunctionJun 16, 2026Failure to Deliver; Connection Problem

  THE PATIENT REPORTED THAT MULTIPLE BOLUS ATTEMPTS WERE MADE, BUT THE SYSTEM WAS UNABLE TO CONFIRM DELIVERY, RESULTING IN AN ¿UNCONFIRMED¿ STATUS FOR THE LAST BOLUS. AT THE TIME OF POD DEACTIVATION, THE SYSTEM INDICATED IT WAS UNABLE TO CONFIRM HOW MUCH OF THE LAST BOLUS WAS DELIVERED, AND THAT THE RECORDED VALUE REFLECTED THE AMOUNT THAT HAD BEEN SCHEDULED FOR DELIVERY. CUSTOMER CONFIRMED THAT THE SYSTEM PROMPTED DEACTIVATION OF THE POD AFTER UNSUCCESSFUL ATTEMPTS TO COMPLETE INSULIN DELIVERY. PATIENT REPORTED COMMUNICATION ISSUES BETWEEN THE POD AND THEIR CONTROLLER. BLOOD GLUCOSE LEVELS WERE NOT REPORTED. MEDICAL TREATMENT WAS NOT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25517588 ↗
• InjuryJun 12, 2026Use of Device Problem; Reset Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA) ON (B)(6) 2026. THE PATIENT¿S IPHONE OMNIPOD APPLICATION GOT RESET AND THEY LOST ALL THEIR CONTROLLER SETTINGS. THEY WERE UNABLE TO SET UP A NEW POD BECAUSE THE SETTINGS WERE MISSING. THE PATIENT'S NURSE SENT THEIR SETTINGS TO THEM, BUT THEY DIDN¿T UNDERSTAND THEM AND WAS DELAYED ENTERING SETTINGS AND THE FOLLOWING DAY SHE NEEDED TO GO TO THE HOSPITAL. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED GREATER THAN 400 MG/DL WHILE WEARING THE POD AN UNSPECIFIED NUMBER OF HOURS. SYMPTOMS REPORTED INCLUDE HYPERGLYCEMIA, CHILLS, ¿HEART WAS BEATING REALLY FAST¿, NAUSEA, VOMITING, WEAKNESS, AND FATIGUE. SHE SPENT TWO DAYS IN THE INTENSIVE CARE UNIT AND RECEIVED UNSPECIFIED TREATMENT FOR DKA. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2026.

  Patient problems: Chills; Elevated Ketones/ Diabetic Ketoacidosis; Fatigue; Hyperglycemia; Nausea; Vomiting

  MAUDE report 25488484 ↗
• MalfunctionJun 9, 2026Unintended System Motion

  IT WAS REPORTED THAT WHILE SKYDIVING, AND WITH THEIR OMNIPOD SYSTEM IN ACTIVITY MODE; THE SYSTEM DELIVERED AN UNCOMMANDED BOLUS OF APPROXIMATELY 6-8 UNITS OF INSULIN DURING AN UNPRESSURIZED FLIGHT TO 14,000 FEET. THE PATIENT'S BLOOD GLUCOSE LEVEL DECREASED TO 34 MG/DL. AS TREATMENT THE PATIENT CONSUMED 200 GRAMS OF CARBOHYDRATES, OVER TWO HOURS, TO STABILIZE THEIR BLOOD GLUCOSE LEVELS. MEDICAL TREATMENT WAS NOT REQUIRED.

  Patient problems: Hypoglycemia

  MAUDE report 25442895 ↗
• InjuryMay 29, 2026Insufficient Device Problem Information

  PATIENT REPORTED THAT A POD WAS NOT BEING WORN AT THE TIME MEDICAL ATTENTION WAS SOUGHT, AS THE POD HAD COME OFF DURING SLEEP. THE PATIENT REPORTED EXPERIENCING NAUSEA AND ELEVATED GLUCOSE VALUES. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL WHERE DIABETIC KETOACIDOSIS WAS DIAGNOSED. INSULIN THERAPY WAS ADMINISTERED AND THE PATIENT WAS HOSPITALIZED FOR THREE DAYS AND BEING DISCHARGED ON (B)(6) 2026. PATIENT STATED THAT THE EVENT WAS NOT RELATED TO RECEIVING INSULIN AFTER THE POD CAME OFF AND THAT THE SYSTEM RECORDS INDICATED THAT THE POD RESERVOIR WAS EMPTY ON (B)(6) 2026. IT IS UNKNOWN WHETHER ANY CONTROLLER MESSAGE WAS DISPLAYED, AS THIS INFORMATION WAS NOT REPORTED. BLOOD GLUCOSE VALUES AT THE TIME OF THE EVENT WERE NOT AVAILABLE, AS THE PATIENT WAS UNABLE TO RECALL.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Nausea

  MAUDE report 25331823 ↗
• MalfunctionMay 21, 2026Unintended System Motion

  IT WAS REPORTED THAT AN UNCOMMANDED BOLUS WAS DELIVERED ON (B)(6) 2026. THE PATIENT STATED THAT THEY NEVER ADMINISTERED A BOLUS, HOWEVER, HER APPLICATION WAS SHOWING BOLUS READINGS RECORDED FOR THAT DAY. NO FURTHER INFORMATION WAS REPORTED. MULTIPLE ATTEMPTS WERE MADE TO REACH THE REPORTER FOR FURTHER INFORMATION, HOWEVER, WERE UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25249886 ↗
• MalfunctionMay 20, 2026Failure to Deliver; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE INCREASED TO 317 MG/DL WHILE WEARING A POD. THE PATIENT EXPLAINED THEY WERE TRYING TO GIVE THEMSELVES AN 11.75-UNIT INSULIN BOLUS BUT DID NOT BELIEVE THEY RECEIVED THE ENTIRE BOLUS. THERE WAS AN UNCONFIRMED BOLUS WHERE THE SCREEN WAS SHOWING EXCLAMATION POINT AND IT WAS TELLING THEM THE UNITS OF INSULIN GIVEN, BUT WHEN THEY CLICKED ON IT, IT SAID, THE LAST BOLUS VALUE IS AN ESTIMATE UNTIL YOUR POD CONFIRMS THAT IT WAS DELIVERED. THEY HAD CHANGED THEIR POD EARLIER THAT MORNING AND THE APPLICATION DID SEEM TO REFLECT THE DISCONTINUATION OF USE OF THE OLD POD BUT HAD CONFLICTING INFORMATION ON THE STATUS OF THE NEW POD. WHEN THEY LOOKED IN HISTORY AND ON EVENTS, THE POD DIDN'T SEEM TO BE ACTIVATED, HOWEVER IF THEY CLICKED ON THE POD IN ANOTHER AREA OF THE SCREEN IT WAS SHOWING ACTIVATED.

  Patient problems: Hyperglycemia

  MAUDE report 25231828 ↗
• InjuryMay 6, 2026Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA) ON (B)(6) 2026. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED GREATER THAN 250 MG/DL WHILE WEARING THE POD. THE POD CONTROLLER GENERATED AN "OMNIPOD 5 APP ERROR" ERROR MESSAGE. THE PATIENT SELECTED ¿OK¿ TO CONTINUE; HOWEVER, THE SYSTEM REMAINED STUCK AT 8% ON THE OMNIPOD 5 LOADING BAR AFTER REBOOTING. THEY ALSO ATTEMPTED TO RESTART THE APP, BUT IT CONTINUED TO FREEZE AT 8%. FURTHERMORE, THEY HAVE BEEN UNABLE TO ADMINISTER INSULIN OR CONTROL THE OMNIPOD SINCE 2:00 PM, SUBSEQUENTLY GOING TO THE HOSPITAL DUE TO FEELING UNWELL. SYMPTOMS REPORTED INCLUDE VOMITING, FEELING AGITATED, DIFFICULTY BREATHING, AND EXPERIENCING CONFUSION. THE PATIENT WAS TREATED WITH ZOFRAN FOR NAUSEA, TWO UNSPECIFIED INTRAVENOUS FLUID BAGS TO HELP STABILIZE THEIR CONDITION AND INSULIN TO HELP LOWER THEIR GLUCOSE LEVELS. THE PATIENT WAS STILL ADMITTED AT THE TIME OF THIS REPORT.

  Patient problems: Cognitive Changes; Dyspnea; Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Vomiting

  MAUDE report 25107755 ↗
• MalfunctionMay 4, 2026Unintended System Motion

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA. THEY STATED THAT THE POD DELIVERED A BOLUS OF 2.1 UNITS OF INSULIN AUTOMATICALLY WITHOUT THEM COMMANDING IT TO. THEIR BLOOD GLUCOSE DECREASED TO APPROXIMATELY 60 MG/DL, PROMPTING THEM TO CONTACT EMERGENCY SERVICES (911). EMERGENCY RESPONDERS ADVISED THE CUSTOMER TO REMOVE THE POD. THE CUSTOMER REPORTED CONSUMING ORANGE JUICE AFTERWARD, FOLLOWING WHICH THEIR BLOOD GLUCOSE LEVELS BEGAN TO IMPROVE. THEY DID NOT REQUIRE TRANSPORT OR REPORT ANY FURTHER TREATMENT.

  Patient problems: Hypoglycemia

  MAUDE report 25074630 ↗
• MalfunctionApr 23, 2026Excess Flow or Over-Infusion; Application Program Problem: Medication Error

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TWO INSTANCES WHERE THEY WENT TO BOLUS AND INPUT 10 G OF CARBS, BUT THE SYSTEM CHANGED WHAT SHOULD BE DELIVERED FOR THE BOLUS UP TO 10 UNITS OF INSULIN. ADDITIONALLY, THEY PAUSED INSULIN DELIVERY, BUT THEY THOUGHT IT KEPT DELIVERING. THE PATIENT REMOVED THE POD. THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION OR TREATMENT. THE FIRST INSTANCE OF THE SAME THING IS REPORTED IN INSULET CASE REFERENCE # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965745 ↗
• MalfunctionApr 23, 2026Excess Flow or Over-Infusion; Application Program Problem: Medication Error

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TWO INSTANCES WHERE THEY WENT TO BOLUS AND INPUT 10 G OF CARBS, BUT THE SYSTEM CHANGED WHAT SHOULD BE DELIVERED FOR THE BOLUS UP TO 10 UNITS OF INSULIN. ADDITIONALLY, THEY PAUSED INSULIN DELIVERY, BUT THEY THOUGHT IT KEPT DELIVERING. THIS FIRST INSTANCE OCCURRED WHEN THE PATIENT WAS ON A FLIGHT. THE PATIENT REMOVED THE POD. THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION OR TREATMENT. THE SECOND INSTANCE OF THE SAME THING IS REPORTED IN INSULET CASE REFERENCE # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965737 ↗
• MalfunctionApr 15, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE PATIENTS' BLOOD GLUCOSE LEVEL DECREASED TO 38 MD/DL AND BELIEVES IT WAS DUE TO A TECHNICAL ISSUE RELATED TO THE AUTOMATED SYSTEM. THE PATIENT REPORTED THAT THEY CALLED THEIR NURSE AND DOCTOR'S OFFICE AND WAS ADVISED TO GO TO THE ER, BUT HE DID NOT GO. THE PATIENT TREATED HIS LOW GLUCOSE LEVEL WITH GLUCOSE TABLETS, SUGAR, JUICE, COFFEE AND FOOD. PATIENT REPORTED THAT THEY DO NOT TRUST AUTOMATED SYSTEMS ANYMORE AND REQUESTED HIS DOCTOR TO UPDATE HIS PRESCRIPTION TO GO BACK TO MANUAL INSULIN INJECTIONS.

  Patient problems: Hypoglycemia

  MAUDE report 24885273 ↗

Other Insulet Corporation products

• Omnipod 58 models · 136,063 reports · 5 recalls
• Omnipod 5 Pod3 models · 133,848 reports · 2 recalls
• Omnipod4 models · 58,769 reports · 1 recall
• Omnipod DASH2 models · 57,338 reports · 2 recalls