Omnipod ZXP420 (REF 14000)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20,092 adverse event reports that list this exact device (DI 10385081120005), received between Oct 19, 2016 and Aug 21, 2026 — classified as 70 deaths, 4,612 injuries, 15,406 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (5,696 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 20,092 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJun 9, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA) ON (B)(6) 2026. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED OVER 400 MG/DL. IT WAS NOTED THAT THE INSULIN FROM THE POD WAS FROZE DUE TO KEEPING IT IN A REFRIGERATOR WHILE CAMPING, CAUSING THE PATIENT¿S BLOOD GLUCOSE TO RISE. SYMPTOMS REPORTED INCLUDE VOMITING, CHEST PRESSURE, AND TROUBLE WALKING. THE PATIENT WAS TREATED WITH INTRAVENOUS (IV) FLUIDS AND INSULIN DRIP. THE PATIENT WAS DISCHARGED ON (B)(6) 2026.

  Patient problems: Ambulation or Postural Difficulties; Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Myocardial Infarction; Vomiting

  MAUDE report 25451736 ↗
• InjuryJun 5, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA) ON AN UNSPECIFIED DATE, ESTIMATED BY THE REPORTER TO BE 5 OR 6 YEARS AGO. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 1000 MG/DL WHILE WEARING THE POD AN UNSPECIFIED DURATION ON THE ABDOMEN. SYMPTOMS REPORTED INCLUDED VOMITING. THE PATIENT WAS TREATED WITH AN UNSPECIFIED INTRAVENOUS FLUID. THE REPORTER DID NOT RECALL THE DISCHARGE DATE SINCE THE HOSPITALISATION OCCURRED A LONG TIME AGO.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Vomiting

  MAUDE report 25408860 ↗
• InjuryJul 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPOGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVELS DECLINED TO 28 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE PATIENT REPORTS FEELING DIZZY AND LOOSING CONSCIOUSNESS. THE PATIENT REPORTS RECEIVING INCORRECT READINGS FROM THEIR DEXCOM SENSOR THAT SHOWED BLOOD GLUCOSE LEVELS AT 185 MG/DL BUT WHEN CHECKING BY FINGER STICK THEIR BLOOD GLUCOSE LEVEL WAS BELOW 70 MG/DL. ONCE THE PARAMEDICS HAD ARRIVED THE PATIENT WAS TREATED WITH SUGAR INJECTIONS AND THEIR BLOOD GLUCOSE LEVEL WAS BELOW 30 MG/DL. THE PATIENT WAS TAKEN TO THE HOSPITAL. TREATMENT AT THE HOSPITAL WAS NOT PROVIDED. THE PATIENT WAS AT THE HOSPITAL FOR 5 HOURS.

  Patient problems: Hypoglycemia

  MAUDE report 22529967 ↗
• MalfunctionJul 14, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVELS (BG) ROSE TO OVER 250 MG/DL, WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (LEG), CAUSING THE CANNULA TO DISLODGE. NO TREATMENT INFORMATION WAS PROVIDED.

  Patient problems: Hyperglycemia

  MAUDE report 22496737 ↗
• MalfunctionJul 7, 2025Loss of or Failure to Bond; Unintended Movement; Loss of or Failure to Bond; Unintended Movement

  IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVELS (BG) ROSE TO OVER 250 MG/DL, WHILE WEARING THE POD LONGER THAN 48 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, THE PATIENT CHANGED OUT THE POD.

  Patient problems: Hyperglycemia

  MAUDE report 22420376 ↗
• MalfunctionJul 7, 2025Loss of or Failure to Bond; Unintended Movement; Loss of or Failure to Bond; Unintended Movement

  IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVELS (BG) ROSE TO OVER 250 MG/DL, WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (ARM), CAUSING THE CANNULA TO DISLODGE. NO TREATMENT INFORMATION WAS PROVIDED.

  Patient problems: Hyperglycemia

  MAUDE report 22420340 ↗
• InjuryJun 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT REPORTED GOING TO THE EMERGENCY ROOM (ER) ON (B)(6) 2025 AFTER EXPERIENCING HIGH BLOOD GLUCOSE LEVELS OVER 24 HOURS. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE 364 MG/DL AND THEY HAD SYMPTOMS OF DIABETIC KETOACIDOSIS (DKA), INCLUDING VOMITING. HER OMNIPOD 5 CONTROLLER SHOWED 3.60 UNITS OF INSULIN ON BOARD (IOB) BUT DID NOT RECOMMEND A CORRECTION. SHE WAS UNAWARE OF DKA OR HOW TO CHECK FOR KETONES. THE PATIENT SPENT FOUR HOURS IN THE ER WHERE SHE RECEIVED INTRAVENOUS (IV) FLUIDS, BLOOD WORK, A NERVE TEST, A SHOT OF HUMALOG, AND OXYGEN. THE POD WAS WORN BETWEEN 1 AND 4 HOURS ON THE ARM. THE PATIENT HAS RECEIVED GUIDANCE FROM THE INSULET CALL AGENT.

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

  MAUDE report 22334944 ↗
• InjuryJun 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD TO SEEK MEDICAL ATTENTION WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED AN UNKNOWN LEVEL. NO INFORMATION WAS PROVIDED ABOUT SYMPTOMS, HOW THEY WERE ABLE TO TREAT THE ISSUE AND THE DURATION OF THE EVENT. THE PATIENT DID NOT REMEMBER DETAILS ABOUT THE EVENT.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 22285098 ↗
• InjuryJun 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED AN UNKNOWN LEVEL WHILE WEARING THE POD LONGER THAN 48 HOURS. THE PATIENT DID NOT PROVIDE INFORMATION ON SYMPTOMS, HOW THEY WERE ABLE TO TREAT THE ISSUE AND THE DURATION OF THE MEDICAL ATTENTION. THE PATIENT DID NOT REMEMBER THE EVENT.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 22285082 ↗
• InjuryJun 12, 2025Material Twisted/Bent; Material Twisted/Bent

  THE PATIENT REPORTED THAT SHE SOUGHT MEDICAL ATTENTION AT THE HOSPITAL DUE TO DIABETIC KETOACIDOSIS (DKA). THE PATIENT'S BLOOD GLUCOSE (BG) VALUES REACHED OVER 250 MG/DL. SHE WAS UNABLE TO PROVIDE SPECIFIC DATES BUT MENTIONED THE INCIDENT OCCURRED 6 OR 7 YEARS AGO. SHE WAS HOSPITALIZED FOR TWO WEEKS. THE PATIENT REPORTED THAT THE CANNULA WAS BENT. DUE TO THE TIME ELAPSED SINCE THE INCIDENT, THE PATIENT COULD NOT CONFIRM DETAILS SUCH AS BLOOD GLUCOSE LEVELS, TREATMENT METHODS, ADHESIVE SECURITY, OR THE MOVEMENT OF THE PINK SLIDE ON THE POD.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 22198302 ↗
• InjuryJun 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A MEDWATCH REPORT WAS RECEIVED ON 6MAY2025 THAT REPORTED THE PATIENT DEVELOPED SEVERE DKA (DIABETIC KETOACIDOSIS) ON (B)(6) 2025. THE PATIENT IS CURRENTLY INTUBATED AND IN A COMA. THE PATIENT ALSO WENT INTO CARDIAC ARREST AND IS REPORTED TO HAVE AN ANOXIC BRAIN INJURY AND IMPENDING BRAIN HERNIATION. THE PATIENT'S NEUROPROGNOSIS WAS REPORTED TO BE POOR. ADDITIONAL INFORMATION WAS NOT PROVIDED. DUE DILIGENCE FOR ADDITIONAL INFORMATION CANNOT BE COMPLETED DUE TO THE PATIENT'S IDENTIFICATION IS UNKNOWN.

  Patient problems: Cardiac Arrest; Cognitive Changes; Coma; Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 22123440 ↗
• MalfunctionMay 22, 2025Loss of or Failure to Bond; Unintended Movement; Loss of or Failure to Bond; Unintended Movement

  IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVELS (BG) ROSE TO OVER 250 MG/DL, WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (LEG), CAUSING THE CANNULA TO DISLODGE. NO TREATMENT INFORMATION WAS PROVIDED.

  Patient problems: Hyperglycemia

  MAUDE report 22068411 ↗
• MalfunctionMay 20, 2025Loss of or Failure to Bond; Unintended Movement; Loss of or Failure to Bond; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 500 MG/DL WHILE WEARING THE POD. THE POD REPORTEDLY FELL OFF THE INFUSION SITE, CAUSING THE CANNULA TO DISLODGE. INFORMATION ON TREATMENT WAS NOT PROVIDED.

  Patient problems: Hyperglycemia

  MAUDE report 22056014 ↗
• MalfunctionMay 20, 2025Loss of or Failure to Bond; Unintended Movement; Loss of or Failure to Bond; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 500 MG/DL WHILE WEARING THE POD. THE POD REPORTEDLY FELL OFF THE INFUSION SITE, CAUSING THE CANNULA TO DISLODGE. INFORMATION ON TREATMENT WAS NOT PROVIDED.

  Patient problems: Hyperglycemia

  MAUDE report 22055500 ↗
• MalfunctionMay 15, 2025Loss of or Failure to Bond; Unintended Movement; Loss of or Failure to Bond; Unintended Movement

  IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVELS (BG) ROSE TO OVER 250 MG/DL, WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (LEG), CAUSING THE CANNULA TO DISLODGE. NO TREATMENT INFORMATION WAS PROVIDED.

  Patient problems: Hyperglycemia

  MAUDE report 22028634 ↗
• InjuryMay 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD TO SEEK MEDICAL ATTENTION WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT'S BLOOD GLUCOSE LEVELS WERE NOT PROVIDED. THE PATIENT REPORTED SHE LOST HER INSURANCE AND RAN OUT OF MEDICATION, BUT DID NOT FURTHER CLARIFY WHAT THE MEDICATION WAS. TREATMENT AND FURTHER INFORMATION WERE NOT REPORTED AND FOLLOW UP ATTEMPTS WERE UNSUCCESSFUL IN OBTAINING FURTHER INFORMATION.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 22014308 ↗
• MalfunctionMay 8, 2025Loss of or Failure to Bond; Unintended Movement; Loss of or Failure to Bond; Unintended Movement

  IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVELS (BG) ROSE TO OVER 250 MG/DL, WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. NO TREATMENT INFORMATION WAS PROVIDED.

  Patient problems: Hyperglycemia

  MAUDE report 21989944 ↗
• InjuryApr 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT REPORTED ONGOING ISSUES WITH HIGH AND LOW BLOOD GLUCOSE (BG) LEVELS, REQUIRING MEDICAL ASSISTANCE AND CONSULTATION WITH HER HEALTHCARE PROVIDER. THE PATIENT MENTIONED THESE ISSUES HAVE BEEN HAPPENING FREQUENTLY, INCLUDING TODAY AND YESTERDAY. DUE TO THE PATIENT BEING A MINOR, PERMISSION FROM A PARENT OR LEGAL GUARDIAN IS NEEDED TO DOCUMENT INFORMATION AND FOLLOW UP. THE AGENT ATTEMPTED TO SET EXPECTATIONS FOR THE CALL FLOW AND OFFERED CPS ASSISTANCE BUT WAS UNABLE TO COMPLETE THE CONVERSATION. NO SPECIFIC BLOOD GLUCOSE READINGS OR TYPE OF MEDICAL TREATMENT RECEIVED WAS PROVIDED. THE PATIENT TERMINATED THE CALL ABRUPTLY, BEFORE ADDITIONAL DETAILS COULD BE OBTAINED. THREE DUE DILIGENCE CALLS WERE MADE IN AN ATTEMPT TO GATHER ADDITIONAL INFORMATION WITHOUT SUCCESS. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER TIME, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857277 ↗
• MalfunctionApr 3, 2025Loss of or Failure to Bond; Unintended Movement; Loss of or Failure to Bond; Unintended Movement

  IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVELS (BG) ROSE TO OVER 250 MG/DL, WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (LEG), CAUSING THE CANNULA TO DISLODGE. NO TREATMENT INFORMATION WAS PROVIDED.

  Patient problems: Hyperglycemia

  MAUDE report 21765655 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPERGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 570 MG/DL WHILE WEARING THE POD LONGER THAN 48 HOURS. THE PATIENT WAS TREATED WITH IV (INTRAVENOUS) FLUIDS AND INSULIN INJECTIONS. THE PATIENT WAS STILL IN THE HOSPITAL AT THE TIME OF THE REPORT. THE POD WAS WORN WHEN SEEKING MEDICAL ATTENTION. IT WAS ALSO REPORTED THAT THE PATIENT IS VERY THIN AND HAS POOR ABSORPTION.

  Patient problems: Hyperglycemia

  MAUDE report 21690791 ↗
• MalfunctionMar 18, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE NEEDLE DEPLOYED THE CANNULA EARLY BEFORE THE PATIENT APPLIED THE POD, INDICATING THAT THERE WAS A NEEDLE MECHANISM FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21630216 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ONLINE BY THE PATIENT'S NEIGHBOR THAT AN OMNIPOD PATIENT HAS UNCONTROLLABLE TYPE 1 DIABETES, LOST HIS INSURANCE, AND HAS NO MEDICATION. HE USES OMNIPOD BECAUSE HE CAN'T SELF-INJECT AND HAS NO HELP. AFTER A 5-WEEK HOSPITAL STAY AND LOWER RIGHT LEG AMPUTATION, HE WAS SENT HOME WITHOUT MEDICINE OR SUPPORT. THE PATIENT'S NAME WAS NOT PROVIDED. THREE DUE DILIGENCE ATTEMPTS WERE MADE TO OBTAIN PATIENT NAME WITHOUT SUCCESS. IF NEW INFORMATION BECOMES AVAILABLE, WE WILL SUPPLEMENT THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21600206 ↗
• MalfunctionMar 12, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVELS ROSE TO OVER 250 MG/DL, WHILE WEARING THE POD. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE. PATIENT REPORTED INTRODUCER NEEDLE FOR THE CANNULA DOES NOT WANT TO GO INTO THEIR SKIN. NO TREATMENT INFORMATION WAS PROVIDED.

  Patient problems: Hyperglycemia

  MAUDE report 21585929 ↗
• MalfunctionMar 7, 2025Loss of or Failure to Bond; Unintended Movement; Loss of or Failure to Bond; Unintended Movement

  IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVELS (BG) ROSE TO OVER 250 MG/DL, WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (BACK), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, NO TREATMENT INFORMATION WAS PROVIDED.

  Patient problems: Hyperglycemia

  MAUDE report 21548662 ↗