OmnipodRecalls & reported problems across all models

We found 4 models of Omnipod by Insulet Corporation in the FDA's device registry (GUDID). Together they are named in 58,769 adverse event reports in the FDA's MAUDE database, received between Oct 19, 2016 and Sep 29, 2026 — classified as 99 deaths, 8,134 injuries, 50,532 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (15,834 reports).

1 FDA recall record name at least one of these models by its device 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. 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 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. May 20, 2026Open, Classified

   External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death.

   Z-2605-2026 · Root cause: Process design · Recall details · FDA record ↗

Most reported Omnipod problems

Omnipod models

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

• Omnipod ZXP420

  Pump, Infusion, Insulin
  1 recall17 deaths37,832 reports
• Omnipod ZXP420

  Pump, Infusion, Insulin
  70 deaths20,092 reports
• Omnipod UST400

  System, Test, Blood Glucose, Over The Counter
  12 deaths816 reports
• Omnipod UST400

  System, Test, Blood Glucose, Over The Counter
  29 reports

Recent Omnipod adverse event reports

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

• MalfunctionSep 29, 2026Loss of or Failure to Bond; Unintended Movement

  It was reported that the patient's blood glucose level rose to greater than 250 mg/dL, while wearing the Pod between 5 and 24 hours. The Pod reportedly detached from the hip/buttocks, causing the cannula to dislodge. As treatment, a new pod was placed.

  Patient problems: Hyperglycemia

  MAUDE report 50934180 ↗
• InjuryAug 21, 2026Insufficient Device Problem Information

  It was reported that the patient developed an infection at the Pod¿s infusion site (unspecified) while wearing the Pod approximately 10 years ago. The patient went to the emergency room and was diagnosed with an unspecified infection. The patient was prescribed unspecified antibiotics. Further details including symptoms, exact date, and specific diagnosis were not available.

  Patient problems: Unspecified Infection

  MAUDE report 50382789 ↗
• MalfunctionAug 19, 2026Premature Activation

  It was reported the needle mechanism had fully deployed before the Pod was able to be used. No impact to the patient's glucose level was reported. The Pod was discarded, and a new Pod was placed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50328894 ↗
• MalfunctionAug 18, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50307971 ↗
• InjuryAug 11, 2026Fluid/Blood Leak

  The patient was wearing a Pod on the hip/buttocks for between 37 and 48 hours. On (b)(6) 2026, while visiting Italy, the patient experienced hyperglycemia with blood glucose reported at 400 mg/dL (22.2 mmol/L) despite multiple correction boluses and minimal food intake. The patient reported increasing ketone levels (approximately 0.4 mmol/L and rising), dizziness, significant weakness, feeling increasingly unwell, and concern that insulin delivery may not have been occurring as expected. The patient reported signs consistent with insulin leakage during wear and reported feeling insulin on the skin. The patient sought medical attention and was treated in the emergency department for approximately 3 hours with intravenous fluids and NovoRapid insulin. The Pod remained in use during medical treatment. After returning to the hotel, the patient removed the Pod and applied a new Pod filled with NovoRapid insulin. Blood glucose and ketone levels subsequently improved, and the reported event resolved.

  Patient problems: Dizziness; Fatigue; Hyperglycemia; Malaise

  MAUDE report 50213917 ↗
• MalfunctionAug 3, 2026Loss of or Failure to Bond; Unintended Movement

  It was reported that the patient's blood glucose level rose to greater than 250 mg/dL, while wearing the Pod between 5 and 24 hours. The Pod reportedly detached from the abdomen, causing the cannula to dislodge. As treatment, a new pod was placed.

  Patient problems: Hyperglycemia

  MAUDE report 50116922 ↗
• MalfunctionJul 30, 2026Fluid/Blood Leak; Difficult to Insert

  Patient problems: Hyperglycemia

  MAUDE report 50093841 ↗
• InjuryJul 9, 2026Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT'S PARTNER THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPERGLYCEMIA ON (B)(6) 2026. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 53 MMOL/L (954 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS ON THE ARM; THE PATIENT'S USUAL BLOOD GLUCOSE RANGE WAS REPORTED TO BE APPROXIMATELY 7 MMOL/L (126 MG/DL). THE PATIENT HAD REPORTEDLY BEEN FEELING UNWELL THROUGHOUT THE DAY AND EXPERIENCED VOMITING, DIZZINESS, AND WEAKNESS. THE PATIENT'S PARTNER REPORTED THAT THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) ON THE EVENING OF (B)(6) 2026. THE REPORTED DIAGNOSIS WAS HIGH GLUCOSE LEVELS. TREATMENT REPORTEDLY INCLUDED ADMINISTRATION OF INTRAVENOUS FLUIDS AND INSULIN. THE PATIENT WAS STILL HOSPITALIZED AT THE TIME OF REPORTING, AND THEREFORE A DISCHARGE DATE WAS NOT AVAILABLE. ADDITIONAL INFORMATION REGARDING THE DATE OF DISCHARGE, HOSPITALIZATION OUTCOME, AND ANY FURTHER MEDICAL ASSESSMENT OF THE RELATIONSHIP BETWEEN THE EVENT AND THE OMNIPOD SYSTEM IS BEING REQUESTED. THE PATIENT CONTINUED TO WEAR THE POD AT THE TIME OF THE REPORT.

  Patient problems: Dizziness; Fatigue; Hyperglycemia; Vomiting

  MAUDE report 25762696 ↗
• InjuryJul 9, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL DROPPED TO AROUND 40 MG/DL WHILE WEARING THE POD. THE PATIENT REPORTED THEY WERE INVOLVED IN A CAR ACCIDENT DUE TO LOW BLOOD GLUCOSE LEVELS BETWEEN LATE (B)(6) 2029 AND EARLY (B)(6) 2019. THE PATIENT WAS TRANSPORTED TO A HOSPITAL WHERE THE PATIENT STAYED FOR 20 HOURS. THE PATIENT REPORTED THEY WERE NOT INJURED, BUT ONLY WOKE AFTER THEY REACHED THE HOSPITAL. THE PATIENT'S POD WAS REMOVED AS IT WAS DAMAGED IN THE ACCIDENT, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS MANAGED USING MANUAL INSULIN INJECTION USING SYRINGES WHILE IN THE HOSPITAL. THE PATIENT'S LOW BLOOD GLUCOSE LEVELS WERE TREATED USING 'LIQUID SUGAR' THROUGH INJECTION. THE PATIENT IS FROM THE UNITED STATES AND WAS IN AN REMOTE ISLAND IN GREECE DURING THE INCIDENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 25760268 ↗
• MalfunctionJul 1, 2026Failure to Fire

  IT WAS REPORTED BY LEGAL GUARDIAN THAT THE PINK SLIDE DID NOT MOVE FORWARD, IS NOT VISIBLE IN THE VIEWING WINDOW AND WHEN THE POD WAS REMOVED THE CANNULA WAS NOT VISIBLE. NO IMPACT TO THE PATIENT'S GLUCOSE LEVEL WAS REPORTED. THE POD WAS NOT WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25679866 ↗
• MalfunctionJul 1, 2026Failure to Fire

  IT WAS REPORTED BY LEGAL GUARDIAN THAT THE PINK SLIDE DID NOT MOVE FORWARD, IS NOT VISIBLE IN THE VIEWING WINDOW AND WHEN THE POD WAS REMOVED THE CANNULA WAS NOT VISIBLE. NO IMPACT TO THE PATIENT'S GLUCOSE LEVEL WAS REPORTED. THE POD WAS NOT WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25679802 ↗
• MalfunctionJun 18, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 28 MMOL/L (504 MG/DL) WHILE WEARING THE POD FOR AN UNKNOWN DURATION. THE DEVICE WAS ORIGINALLY REPORTED FOR POD CUSTOMER NOT SURE DELIVERING INSULIN. INVESTIGATION OF THE DEVICE FOUND A TEAR IN THE EXPOSED PORTION OF THE CANNULA AND THE TIP OF THE NEEDLE TO BE DULL.

  Patient problems: Hyperglycemia

  MAUDE report 25556356 ↗
• MalfunctionJun 12, 2026Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 20 MMOL/L (360 MG/DL) WHILE WEARING THE POD FOR AN UNSPECIFIED AMOUNT OF TIME. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE (HIP/BUTTOCKS). AS TREATMENT, A NEW POD WAS APPLIED.

  Patient problems: Hyperglycemia

  MAUDE report 25487585 ↗
• InjuryJun 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SOUGHT MEDICAL ATTENTION ON (B)(6) 2026 WITH SKIN IRRITATION WITH PURULENT DISCHARGE AT THE INFUSION SITE (LEG) WHILE WEARING THE POD BETWEEN 25 AND 36 HOURS. THE PATIENT¿S BLOOD GLUCOSE LEVELS ROSE TO 400 MG/DL AT THIS TIME. AS TREATMENT, THE PATIENT WAS PRESCRIBED AN UNSPECIFIED TOPICAL OINTMENT.

  Patient problems: Hyperglycemia; Purulent Discharge; Skin Inflammation/ Irritation

  MAUDE report 25483039 ↗
• MalfunctionJun 9, 2026Loss of or Failure to Bond; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO GREATER THAN 250 MG/DL WHILE WEARING THE POD WORN LESS THAT 1 HOUR. THE ADHESIVE COMPLETELY SEPARATED FROM THE (LEG) CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS INSERTED.

  Patient problems: Hyperglycemia

  MAUDE report 25451752 ↗

Other Insulet Corporation products

• Omnipod 58 models · 136,063 reports · 5 recalls
• Omnipod 5 Pod3 models · 133,848 reports · 2 recalls
• Omnipod DASH2 models · 57,338 reports · 2 recalls
• Omnipod 5 Controller APP4 models · 99 reports · 3 recalls