Omnipod PodPals POD-X9-990Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10385081120234), received between May 20, 2024 and Jun 25, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PERSISTENT RASH AT THE SITE WHERE A POD PAL ADHESIVE HAD PREVIOUSLY BEEN APPLIED TO THE LEG. THE PATIENT REPORTED REDNESS OF THE SKIN THAT HAD NOT RESOLVED AND SOUGHT MEDICAL ATTENTION FROM AN ENDOCRINOLOGIST IN (B)(6) 2026. THE VISIT WAS NOTED AS AN OUTPATIENT VISIT, WITH NO FORMAL DIAGNOSIS PROVIDED. THE HEALTHCARE PROFESSIONAL PRESCRIBED AN ANTI-INFLAMMATORY TREATMENT; HOWEVER, THE PATIENT DID NOT OBTAIN OR USE THE PRESCRIBED MEDICATION AND INSTEAD REPORTED SELF-USE OF A NON-PRESCRIBED TOPICAL AGENT (POLYSPORIN). NO BLOOD GLUCOSE LEVELS WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Erythema; Rash; Skin Inflammation/ Irritation

  MAUDE report 25630183 ↗
• InjuryJun 5, 2026Insufficient Device Problem Information

  A LEGAL GUARDIAN (LG) REPORTED THAT THE PATIENT EXPERIENCED AN ALLEGED ALLERGIC SKIN REACTION ASSOCIATED WITH USE OF A PODPAL ADHESIVE WHILE WEARING A POD. THE PATIENT HAD BEEN WEARING THE POD ON THE LEG FOR AN UNKNOWN DURATION OF USE. THE EVENT WAS REPORTED RETROSPECTIVELY AND WAS STATED TO HAVE OCCURRED IN EARLY JUNE 2025. ACCORDING TO THE LG, USE OF THE PODPAL RESULTED IN SKIN IRRITATION CHARACTERIZED BY REDNESS AND INFLAMMATION. THE PATIENT SOUGHT MEDICAL ATTENTION ON (B)(6) 2025 DURING A ROUTINE HEALTHCARE PROVIDER APPOINTMENT, DURING WHICH THE SKIN REACTION WAS OBSERVED AND DISCUSSED. THE POD AND PODPAL HAD BEEN REMOVED PRIOR TO THE APPOINTMENT DUE TO DISCOMFORT DURING REMOVAL. NO POD WAS WORN AT THE TIME MEDICAL ATTENTION WAS SOUGHT. THE HEALTHCARE PROVIDER PRESCRIBED TOPICAL TREATMENT (TRIAMCINOLONE ACETONIDE CREAM). THE DIAGNOSIS SPECIFIC TO THE EVENT WAS DOCUMENTED AS AN ALLERGIC REACTION TO ADHESIVE.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation

  MAUDE report 25416950 ↗
• InjuryMar 17, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ONGOING SKIN IRRITATION CHARACTERIZED BY ABRADED SKIN, SIGNIFICANT PAIN, REDNESS, SWELLING, AND INFECTION AT THE APPLICATION SITES. DUE TO THE SEVERITY AND PERSISTENCE OF THESE REACTIONS, THE PATIENT SOUGHT MEDICAL EVALUATION AT (B)(6). DURING SUBSEQUENT MEDICAL ASSESSMENTS AND FOLLOW-UP VISITS, MULTIPLE EVALUATIONS WERE PERFORMED TO DETERMINE THE CAUSE OF THE SKIN REACTIONS. IT WAS DETERMINED THAT THE IRRITATION WAS ASSOCIATED WITH THE POD PAL ADHESIVE. THE AFFECTED SITES WERE CONSISTENTLY REPORTED AS PAINFUL, IRRITATED, AND INFECTED, NECESSITATING WEEKLY HOSPITAL VISITS FOR MONITORING. TREATMENT INCLUDED THE USE OF AN IODIZED SCRUB FOR SKIN IRRITATION. ADDITIONALLY, THE PATIENT REPORTED ELEVATED BLOOD GLUCOSE LEVELS REACHING 22.8 MMOL/L (410 MG/DL) WHILE WEARING THE POD. SYMPTOMS WERE REPORTED TO HAVE BEGUN IN EARLY (B)(6) 2025, WITH MEDICAL ATTENTION SOUGHT ON (B)(6) 2025. THE POD WAS NOT WORN AT THE TIME MEDICAL ATTENTION WAS SOUGHT DUE THE PAIN AND SKIN IRRITATION.

  Patient problems: Abrasion; Erythema; Pain; Rash; Skin Infection; Skin Inflammation/ Irritation; Swelling/ Edema; Urticaria

  MAUDE report 24619946 ↗
• InjuryOct 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT EXPERIENCED A SEVERE ALLERGIC REACTION TO THE POD PALS ADHESIVE, STARTING AT THE APPLICATION / INFUSION SITE AND SPREADING ACROSS THE ENTIRE BACK. THE POD WAS WORN FOR LONGER THAN 72 HOURS, WHICH MAY HAVE WORSENED THE REACTION. INITIAL TREATMENT RECOMMENDED BY THE PHARMACY WAS WITH PURITAN AND IT PROVIDED SHORT-TERM RELIEF, BUT SYMPTOMS RETURNED AFTER DISCONTINUATION. THE DERMATOLOGIST LATER PRESCRIBED ELOCON 0.01% OINTMENT, A STRONG STEROID, APPLIED DAILY FOR TWO WEEKS, THEN EVERY OTHER DAY. BARRIER CREAMS LIKE CAVILON WERE INEFFECTIVE DUE TO THE SEVERITY OF THE INFLAMMATION. THE PATIENT IS NOW USING A MEDICATED BARRIER STICK (TAC) BETWEEN THE SKIN AND POD TO PREVENT FURTHER REACTIONS.

  Patient problems: Skin Inflammation/ Irritation; Urticaria

  MAUDE report 23376940 ↗
• InjuryApr 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SKIN IRRITATION CAUSING ITCHING, REDNESS AND AN ALLERGIC REACTION FROM THE PODPAL BEING WORN FOR 3 DAYS. THE PATIENT REPORTS THEY HAD GONE TO THEIR DOCTORS OFFICE WHERE THEY WERE PRESCRIBED LORATADINE. THE PATIENT WAS AT THEIR DOCTORS OFFICE FOR 1 HOUR.

  Patient problems: Itching Sensation; Skin Inflammation/ Irritation; Urticaria

  MAUDE report 21876500 ↗
• InjuryDec 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT THAT THEY HAD A ALLERGIC REACTION TO THE PODPAL ADHESIVE AND IT CAUSED A SKIN IRRITATION. THE SITE ON HER LEG WAS DISCOLORED AND THERE WAS A SCAR. THE PODPAL WAS APPLIED TO THE LEG LONGER THAN 48 HOURS.

  Patient problems: Burning Sensation; Hypersensitivity/Allergic reaction; Scar Tissue; Skin Discoloration; Skin Inflammation/ Irritation

  MAUDE report 20881393 ↗
• InjuryJul 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE POD PAL ADHESIVE CAUSED THE PATIENT'S SKIN TO BE ITCHY, IRRITATED, RED AND UNCOMFORTABLE. THE PATIENT CONSULTED THE DOCTOR AND WAS PRESCRIBED AN OINTMENT AFLUMYCIN FOR TREATMENT.

  Patient problems: Discomfort; Erythema; Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 19792033 ↗
• InjuryJun 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN IRRITATION WHEN WEARING PODPALS BETWEEN 25 AND 36 HOURS. THE PATIENT SAID THE PODS DO NOT CAUSE IRRITATION, ONLY WHEN THEY WEAR THE PODPALS. THEY WENT TO A DOCTOR WAS PRESCRIBED SKIN PROTECTION NOVATECH SMTA, A DRY WASH CREAM TO ADMINISTER TWICE A WEEK AND AN ANTI-ADHESIVE, LABORATOIRE GILBERT, EVERY TIME THEY APPLY A NEW POD.

  Patient problems: Erythema; Skin Inflammation/ Irritation

  MAUDE report 19482559 ↗
• InjuryMay 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED IRRITATION AFTER WEARING PODPALS. THE PATIENT WENT TO THEIR DOCTOR AND WAS PRESCRIBED A ZERO BASE CREAM.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 19352224 ↗