ZIO XT Patch N100A102XRecalls & reported problems

Summary

The FDA's MAUDE database contains 352 adverse event reports that list this exact device (DI 00869770000203), received between Nov 1, 2016 and Jan 22, 2026 — classified as 1 death, 325 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (277 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 352 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2026Patient-Device Incompatibility

  THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER (HCP) WITH SIGNS OF SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO MONITOR. THE PATIENT EXPERIENCED ITCHING, REDNESS, SPOTS AND A RASH. THE PATIENT WAS PRESCRIBED HYDROCORTISONE CREAM.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24155882 ↗
• InjuryAug 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER (HCP) WITH SIGNS OF SKIN IRRITATION AND ALLERGIC REACTION ALLEGEDLY CAUSED BY THE ZIO XT. THE PATIENT EXPERIENCED REDNESS AND BLISTERS WITH BROKEN SKIN. THE DEVICE WAS REMOVED AND THE PATIENT WAS PRESCRIBED UNKNOWN ANTIBIOTICS.

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

  MAUDE report 22801016 ↗
• InjuryAug 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2021, IRHYTHM RECEIVED A MEDWATCH REPORT (MW5099082) ALLEGING THAT A PATIENT DEVELOPED LOCALIZED SKIN IRRITATION AND A RASH AT THE ZIO XT SITE. ACCORDING TO THE REPORT, THE PATIENT EXPERIENCED REDNESS AND A BURNING SENSATION. PRIOR TO DEVICE PLACEMENT, THE PATIENT SIGNED AN INFORMED CONSENT FORM AND WAS ADVISED THAT SKIN IRRITATION IS A KNOWN POTENTIAL SIDE EFFECT. THE PATIENT WAS INSTRUCTED TO REMOVE THE DEVICE AT HOME, AND IT WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Anaphylactoid / Anaphylaxis; Erythema; Hypersensitivity/Allergic reaction; Rash

  MAUDE report 22800886 ↗
• InjuryAug 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER WITH SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO XT. THEY EXPERIENCED ITCHING, BLISTERS AND A RASH WHICH SPREAD ACROSS THE LEFT CHEST AND UNDER THE ARM. FOLLOWING EXAMINATION, THE HCP DIAGNOSED THE PATIENT WITH SEVERE CONTACT DERMATITIS. THE ZIO XT DEVICE WAS REMOVED, AND THE PATIENT WAS ADMINISTERED A PREDNISONE INJECTION AND PRESCRIBED A STEROID PACK FOR TREATMENT.

  Patient problems: Contact Dermatitis

  MAUDE report 22800877 ↗
• InjuryAug 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER WITH SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO XT. THE PATIENT EXPERIENCED REDNESS, RASH, AND ITCHINESS. DESPITE THE REACTION, THE PATIENT CONTINUED TO WEAR THE DEVICE FOR THE REST OF THE PRESCRIBED PERIOD. SUBSEQUENTLY, THE ZIO XT WAS REMOVED. THE PATIENT WAS PRESCRIBED AN OINTMENT TO TREAT THE AFFECTED AREA; HOWEVER, EXPRESSED NO RELIEF.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22800867 ↗
• InjuryAug 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT REPORTED EXPERIENCING SKIN IRRITATION ALLEGEDLY CAUSED BY CAUSED BY ZIO XT. THEY EXPERIENCED ITCHY RED BUMPS. IRHYTHM ADVISED THE PATIENT TO REMOVE THE DEVICE IF SYMPTOMS BECAME INTOLERABLE. DESPITE THE REMOVAL OF THE ZIO XT, THE PATIENT'S SYMPTOMS CONTINUED TO WORSEN. THE PATIENT SUBSEQUENTLY SOUGHT MEDICAL ATTENTION FROM THEIR HEALTHCARE PROVIDER (HCP), AND UPON EXAMINATION THE HCP DIAGNOSED FOLLICULITIS. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND A TOPICAL CREAM FOR TREATMENT.

  Patient problems: Skin Infection

  MAUDE report 22800816 ↗
• InjuryAug 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT PRESENTED TO THE HEALTHCARE PROVIDER WITH SIGNS OF AN ALLERGIC REACTION, REPORTEDLY CAUSED BY THE ZIO XT. THE PATIENT STATED THAT HIVES DEVELOPED WITHIN 48 HOURS AFTER THE ZIO XT APPLICATION. DESPITE THIS REACTION, THE PATIENT CONTINUED TO WEAR THE ZIO XT FOR THE REST OF THE PRESCRIBED PERIOD. THE PATIENT WAS PRESCRIBED BENADRYL AND PREDNISONE FOR TREATMENT.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22800799 ↗
• InjuryAug 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT PRESENTED TO THE URGENT CARE WITH AN ANAPHYLACTIC ALLERGIC REACTION AND SIGNS OF A SECONDARY INFECTION ALLEGEDLY CAUSED BY THE ZIO XT. THE PATIENT REPORTED THAT ON DAY TWO, THEY EXPERIENCED ITCHING, REDNESS, PAIN, AND A RASH. AS A RESULT, THEY REMOVED THE DEVICE AND APPLIED A MEDICATED CREAM AND BENADRYL AT HOME. THE PATIENT¿S SYMPTOMS PROGRESSED OVER TIME, INCLUDING TROUBLE SWALLOWING. WHILE AT THE URGENT CARE, THE PATIENT WAS ADMINISTERED A STEROID SHOT, MEDICATIONS, AND A CREAM. THE PATIENT IS CURRENTLY RECOVERING.

  Patient problems: Anaphylactoid / Anaphylaxis; Hypersensitivity/Allergic reaction

  MAUDE report 22800602 ↗
• InjuryJul 24, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER (HCP) WITH SIGNS OF A SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO XT. THE PATIENT EXPERIENCED SYMPTOMS OF ITCHING, IRRITATED, AND INFLAMED SKIN THAT RESEMBLED A BURN. THE DEVICE WAS REMOVED, AND THE HCP DIAGNOSED THE CONDITION AS A RASH. THE PATIENT WAS PRESCRIBED TRIAMCINOLONE 0.1% CREAM TO APPLY AS POST-CARE TREATMENT.

  Patient problems: Rash; Skin Inflammation/ Irritation

  MAUDE report 22586439 ↗
• InjuryJun 6, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER WITH SKIN IRRITATION AND SIGNS OF A SECONDARY INFECTION, ALLEGEDLY CAUSED BY THE ZIO XT. THE PATIENT EXPERIENCED IRRITATION FOR APPROXIMATELY FOUR TO FIVE DAYS WHILE WEARING THE DEVICE. SUBSEQUENTLY, THEY DEVELOPED PUS-FILLED BLISTERS AT THE APPLICATION SITE. THE PATIENT WAS ADVISED TO REMOVE THE DEVICE. THE NURSE PRESCRIBED AN ORAL ANTIBIOTIC FLUCLOXACILLIN AS PART OF POST-CARE.

  Patient problems: Skin Infection

  MAUDE report 22157831 ↗
• InjuryJun 4, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER WITH SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO XT. THE PATIENT EXPERIENCED BROKEN SKIN DUE TO BLISTERS. AS A RESULT, THE DEVICE WAS REMOVED, AND THE PATIENT WAS PRESCRIBED ANTIBIOTIC CREAM AS A PRECAUTIONARY TREATMENT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22142497 ↗
• InjuryMar 28, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER WITH SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO XT. THE PATIENT EXPERIENCED ITCHING AND BLISTERS. THE ZIO XT WAS REMOVED, AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21720758 ↗
• InjuryMar 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER WITH SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO XT. THE PATIENT EXPERIENCED A RASH THAT SEEMED TO EXACERBATE THEIR ECZEMA. DESPITE THE REACTION, THE PATIENT CONTINUED TO WEAR THE DEVICE FOR THE REST OF THE PRESCRIBED PERIOD. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH A TRANSIENT ACANTHOLYTIC DERMATOSIS. THE ZIO XT WAS REMOVED, AND THE PATIENT WAS PRESCRIBED TRIAMCINOLONE ACETONIDE CREAM TO TREAT THE REACTION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21702739 ↗
• InjuryMar 14, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT PRESENTED TO URGENT CARE AND THEIR HEALTHCARE PROVIDER WITH SIGNS OF AN ALLERGIC REACTION ALLEGEDLY CAUSED BY THE ZIO XT. THE PATIENT DEVELOPED REDNESS, A BURNING SENSATION, AND BLISTERS ON THEIR SKIN. THEY ALSO REPORTED FEELING UNCOMFORTABLE. THE DEVICE WAS REMOVED, AND THE PATIENT WAS PRESCRIBED TRIAMCINOLONE AND ADVISED TO USE OVER-THE-COUNTER BENADRYL FOR TREATMENT.

  Patient problems: Blister; Erythema; Hypersensitivity/Allergic reaction; Skin Burning Sensation

  MAUDE report 21610097 ↗
• InjuryMar 7, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER WITH A SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO XT. THE PATIENT EXPERIENCED ITCHING AND REDNESS OF THE SKIN. THE PATIENT REPORTED THAT THE ZIO XT HAD DETACHED, AND THEY REAPPLIED THE DEVICE USING MEDICAL TAPE, WHICH SEEMED TO WORSEN THE IRRITATION. THE DEVICE WAS REMOVED, AND THE PATIENT WAS PRESCRIBED A TOPICAL OINTMENT (HYDROCORTISONE) FOR TREATMENT.

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

  MAUDE report 21552788 ↗
• InjuryMar 7, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER WITH SIGNS OF AN ALLERGIC REACTION ALLEGEDLY CAUSED BY THE ZIO XT. THE PATIENT¿S SKIN EXPERIENCED AN ITCHING AND BURNING SENSATION. THE DIAGNOSIS CONFIRMED AN ALLERGIC REACTION, AND THE PATIENT WAS PRESCRIBED KETOCONAZOLE CREAM AND BETAMETHASONE OINTMENT FOR TREATMENT.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; Skin Burning Sensation

  MAUDE report 21552376 ↗
• InjuryMar 7, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ON FEBRUARY 7, 2025, IRHYTHM BECAME AWARE OF A MEDWATCH REPORT (MW5165294), WHICH STATED THAT A PATIENT EXHIBITED SIGNS OF SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO XT. ACCORDING TO THE REPORT, THE PATIENT EXPERIENCED BRIGHT RED DISCOLORATION, BURNING, AND ITCHING WITHIN THE FIRST 4 MINUTES OF APPLICATION. ADDITIONALLY, THE PATIENT DEVELOPED SHORTNESS OF BREATH. AFTER REMOVING THE DEVICE, A PROMINENT RED MARK APPEARED, ACCOMPANIED BY A BLOOD BLISTER, TENDERNESS, AND DRYNESS. THE PATIENT REPORTS TAKING B12 VITAMIN, A MULTIVITAMIN AND VITAMIN C AS TREATMENT. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Blister; Dyspnea; Erythema; Itching Sensation; Skin Burning Sensation

  MAUDE report 21552375 ↗
• InjuryMar 4, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER WITH SIGNS OF A SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO XT. THE PATIENT¿S SKIN EXHIBITED A RASH ACCOMPANIED BY ITCHING. THE PATIENT WAS PRESCRIBED TRIAMCINOLONE .01%. NO ADDITIONAL DETAILS WERE OBTAINED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21518039 ↗
• InjuryFeb 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER WITH A SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO XT. THE REACTION CAUSED REDNESS AND ITCHINESS ON THEIR CHEST. THE DEVICE WAS REMOVED, AND THE PATIENT WAS GIVEN A PRESCRIPTION FOR TREATMENT.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21433774 ↗
• InjuryFeb 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER WITH SIGNS OF A SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO XT. THE PATIENT REPORTED THAT THEY EXPERIENCED REDNESS AND THE DEVICE WAS CAUSING THEIR SKIN TO ITCH. THE PATIENT WAS TREATED WITH BENADRYL AND ZYRTEC. THERE WERE NO ADDITIONAL DETAILS PROVIDED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21432623 ↗
• InjuryJan 10, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER WITH A SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO XT. THE PATIENT EXPERIENCED MOISTURE OOZING UNDER THE PATCH, INFLAMED SKIN, AND A BURNING SENSATION. AS A RESULT OF THE MOISTURE, THE DEVICE DETACHED FROM THEIR SKIN. DESPITE THIS REACTION, THE HEALTHCARE PROVIDER ADVISED THE PATIENT TO CONTINUE WEARING THE DEVICE, AND IT WAS REAPPLIED USING MEDICAL TAPE. THE PATIENT WAS PRESCRIBED TRIAMCINOLONE ACETONIDE 0.5% OINTMENT AND DOXYCYCLINE TABLETS TO BE TAKEN TWICE DAILY FOR 7 DAYS.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21126914 ↗
• InjuryJan 7, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT PRESENTED TO URGENT CARE WITH A SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO XT. THE PATIENT EXPERIENCED WELTS AT THE ZIO XT SITE. AS A RESULT, THE DEVICE WAS REMOVED, AND THE PATIENT WAS PRESCRIBED TRIAMCINOLONE ACETONIDE OINTMENT AS PART OF POST-CARE.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21096474 ↗
• InjuryDec 12, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT PRESENTED WITH SIGNS OF AN ALLERGIC REACTION ALLEGEDLY CAUSED BY THE ZIO XT TO THEIR HEALTHCARE PROVIDER. THE PATIENT EXPERIENCED ITCHY RED MARKS ON THEIR CHEST. AS A RESULT, THE DEVICE WAS REMOVED, AND THE PATIENT WAS PRESCRIBED A STEROID CREAM-TRIAMCINOLONE TO APPLY TO THE AFFECTED AREA.

  Patient problems: Anaphylactoid / Anaphylaxis; Hypersensitivity/Allergic reaction

  MAUDE report 20914707 ↗
• InjuryDec 10, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER WITH SKIN IRRITATION AND SIGNS OF A SECONDARY INFECTION, ALLEGEDLY CAUSED BY THE ZIO XT. THE PATIENT REPORTED EXPERIENCING ITCHING AND REDNESS AT THE ZIO XT SITE. THE DEVICE WAS REMOVED, AND THE PATIENT WAS PRESCRIBED TOPICAL OINTMENT AS PART OF POST-CARE.

  Patient problems: Unspecified Heart Problem

  MAUDE report 20892750 ↗
• InjuryNov 22, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT REPORTED SKIN IRRITATION WITH ITCHING AND REDNESS TO THEIR HEALTHCARE PROVIDER, WHICH THE ZIO XT ALLEGEDLY CAUSED. THE PATIENT BELIEVES THAT THE IRRITATION BEGAN DURING THE ABRASION PROCESS PRIOR TO THE APPLICATION OF THE DEVICE. DESPITE THE REACTION, THE PATIENT CONTINUED TO WEAR THE DEVICE. THE PATIENT WAS PRESCRIBED TRIAMCINOLONE ACETONIDE CREAM (STEROIDS) TO APPLY AT THE XT SITE.

  Patient problems: Unspecified Heart Problem

  MAUDE report 20761781 ↗