Omnipod ZXP420 (REF 19191)Recalls & reported problems

Summary

The FDA's MAUDE database contains 37,832 adverse event reports that list this exact device (DI 10385081120036), received between Jul 25, 2018 and Sep 29, 2026 — classified as 17 deaths, 2,855 injuries, 34,960 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (12,016 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 37,832 reports, 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 ↗
• 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 ↗
• MalfunctionJun 9, 2026Loss of or Failure to Bond; Unintended Movement

  NOT APPLICABLE AS THE EVENT IS NOT REPORTABLE.

  Patient problems: Hyperglycemia

  MAUDE report 25451740 ↗
• MalfunctionMay 13, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163023 ↗
• MalfunctionMay 12, 2026Failure to Fire

  IT WAS REPORTED BY THE MOTHER OF A PATIENT THAT THE NEEDLE DID NOT MOVE FORWARD WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE. THE POD WAS NOT WORN. NO IMPACT TO THE PATIENT'S GLUCOSE LEVEL WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148415 ↗
• MalfunctionMay 8, 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. THE ADHESIVE COMPLETELY SEPARATED CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS INSERTED.

  Patient problems: Hyperglycemia

  MAUDE report 25131268 ↗
• InjuryMay 8, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT, ON (B)(6) 2024, THE PATIENT WAS HOSPITALISED AT (B)(6), INCLUDING ADMISSION TO THE INTENSIVE CARE UNIT, WITH A DIAGNOSIS OF A BASAL GANGLIA HAEMORRHAGE. THE PATIENT WAS USING OMNIPOD EROS SYSTEM AT THE TIME OF THE EVENT BUT IT WAS IMMEDIATELY DISPOSED OF ON ADMISSION. THE NAME OF THE HEALTHCARE PROFESSIONAL WHO TREATED THE PATIENT WAS NOT RECALLED BY THE COMPLAINANT. TREATMENT THE PATIENT RECEIVED INCLUDED THROMBO ASS, CEREBOKAN AND PRONERV. THE PATIENT'S WIFE STATED THE EVENT WAS NOT LINKED TO A DEVICE FAILURE BUT LIKELY A COMPLICATION FROM A LONGSTANDING DIAGNOSIS OF DIABETES. THE PATIENT RESUMED OMNIPOD SYSTEM USE IN (B)(6) 2025. AS A RESULT OF THE HAEMORRHAGE, THE PATIENT HAS ONGOING COGNITIVE IMPAIRMENT AND IMPAIRED MOTOR FUNCTION. THE PATIENT WAS HOSPITALISED FOR A TOTAL OF 37 DAYS ((B)(6) 2025).

  Patient problems: Cognitive Changes; Stroke/CVA

  MAUDE report 25124631 ↗
• MalfunctionMay 4, 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 ADHESIVE COMPLETELY SEPARATED FROM THE (ABDOMEN) CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS INSERTED.

  Patient problems: Hyperglycemia

  MAUDE report 25075880 ↗
• InjuryMay 1, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE POD¿S INSERTION SITE WHILE WEARING THE POD. THE PATIENT REPORTED THE INFUSION SITE TO BE VERY RED WITH BLISTERING, ITCHINESS, AND DRAINAGE CONSISTING OF WOUND FLUID, WITH NO BLEEDING NOTED. DUE TO CONCERN FOR INFECTION AND A KNOWN SEVERE ADHESIVE ALLERGY, THE PATIENT REMOVED THE POD AND SOUGHT MEDICAL ATTENTION FROM AN INTERNIST. UPON EXAMINATION, THE INTERNIST CLEANED THE SITE WITH ALCOHOL AND DIAGNOSED A SKIN INFECTION ASSOCIATED WITH AN ADHESIVE REACTION. THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS FLUTICASON. FOR FUTURE POD USE, THE INTERNIST PRESCRIBED FLUTICASONE SPRAY TO APPLY TO THE SKIN PRIOR TO POD PLACEMENT TO REDUCE ALLERGIC REACTIONS. THE PATIENT REPORTS THIS TREATMENT HAS EFFECTIVELY PREVENTED FURTHER INFECTIONS, WITH ONLY MILD REDNESS OCCURRING IF THE SPRAY LAYER IS TOO THIN. A NEW POD WAS PLACED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Erythema; Itching Sensation; Purulent Discharge; Skin Infection; Skin Inflammation/ Irritation; Urticaria

  MAUDE report 25058440 ↗
• MalfunctionApr 1, 2026Failure to Fire

  IT WAS REPORTED BY XXX THAT THE NEEDLE DID NOT MOVE FORWARD WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE. THE POD WAS NOT WORN. NO IMPACT TO THE PATIENT'S GLUCOSE LEVEL WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757836 ↗
• MalfunctionApr 1, 2026Fluid/Blood Leak; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO BETWEEN 16.7 MMOL/L AND 22.2 MMOL/L (300 MG/DL AND 400 MG/DL) WHILE WEARING THE POD BETWEEN 5 AND 24 HOURS. THE PATIENT REPORTED INSULIN LEAKING WHILE WEARING THE POD. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD WAS APPLIED.

  Patient problems: Hyperglycemia

  MAUDE report 24757693 ↗
• MalfunctionApr 1, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO GREATER THAN 13.9 MMOL/L (250 MG/DL) WHILE WEARING THE POD BETWEEN 5 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD WAS APPLIED.

  Patient problems: Hyperglycemia

  MAUDE report 24757638 ↗
• MalfunctionApr 1, 2026Fluid/Blood Leak; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 22.2 MMOL/L (400 MG/DL) WHILE WEARING THE POD BETWEEN 5 AND 24 HOURS. THE PATIENT REPORTED INSULIN LEAKING WHILE WEARING THE POD. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD WAS APPLIED.

  Patient problems: Hyperglycemia

  MAUDE report 24757279 ↗