Zio monitor DFG0001Recalls & reported problems
Irhythm Technologies, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This iRhythm Zio monitor has 324 reports, including 315 injuries and no deaths. Most describe skin irritation, rashes and allergic reactions at the application site, and some mention burns and skin infections. No recalls name this device. Reports rose to 186 in the last 12 months from 107 in the 12 months before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 324
- Deaths reported
- 0
- Injuries reported
- 315
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 324 adverse event reports that list this exact device (DI 00869770000241), received between Oct 31, 2023 and Aug 24, 2026 — classified as 315 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (309 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.
Reports received per month
Most reported problems
Device problems
- Patient-Device Incompatibility309
- Patient Data Problem8
- Insufficient Device Problem Information2
- Patient Device Interaction Problem2
- Adverse Event Without Identified Device or Use Problem1
- Gel Leak1
- No Apparent Adverse Event1
- Use of Device Problem1
Patient problems
- Skin Inflammation/ Irritation195
- Hypersensitivity/Allergic reaction112
- Contact Dermatitis23
- Skin Infection18
- Anaphylactoid / Anaphylaxis11
- Unspecified Heart Problem7
- Blister5
- Burn(s)5
Recent adverse event reports
The 25 most recent of 324 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2026Gel Leak; Patient-Device Incompatibility
I was prescribed this device from my neurologist I had it on for two days and it was soitchy and irritable, it almost felt like it was brining me. I was just in the hospital and hadadhesives on me and had no reaction to them. With the ZIOpatch, on the second day, itstarted leaking a black gel and then I got a bad burning sensation. I used the adhesiveremover wipe immediately and took it off to see it had burnt my skin. / UDI:(b)(4) (Zio monitor Recorder, Magnetic Tape, Medical).
Patient problems: Burning Sensation; Itching Sensation; Skin Inflammation/ Irritation
MAUDE report 50410091 ↗InjuryMay 29, 2026Patient-Device Incompatibility
THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER (HCP) WITH SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO MONITOR. THE PATIENT REPORTED EXPERIENCING A RASH AND HIVES AT THE APPLICATION SITE. THE PATIENT STATED THAT THE HCP RECOMMENDED OVER-THE-COUNTER (OTC) BENADRYL AND PRESCRIBED AN UNSPECIFIED ANTI-ITCH CREAM FOR TREATMENT. THE DEVICE WAS SUBSEQUENTLY REMOVED.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 25332243 ↗InjuryMay 29, 2026Patient-Device Incompatibility
THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER (HCP) WITH SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO MONITOR. THE PATIENT REPORTED EXPERIENCING A RASH, BLISTERS, ITCHING, REDNESS AND A BURNING SENSATION AT THE APPLICATION SITE. THE DEVICE WAS REMOVED. THE PATIENT REPORTED BEING EVALUATED BY AN HCP, WHO DIAGNOSED AN ALLERGIC REACTION AND PRESCRIBED ORAL CETIRIZINE, MUPIROCIN OINTMENT, AND HYDROCORTISONE OINTMENT FOR TREATMENT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 25332239 ↗InjuryMay 29, 2026Patient-Device Incompatibility
A FAMILY MEMBER OF THE PATIENT REPORTED THAT THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER (HCP) WITH SIGNS OF SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO MONITOR. THE PATIENT EXPERIENCED SYMPTOMS OF REDNESS, BLISTERS AND HIVES. THE PATIENT WAS PRESCRIBED TRIAMCINOLONE CREAM AS TREATMENT.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 25331270 ↗InjuryMay 29, 2026Patient-Device Incompatibility
THE PATIENT REPORTED SEEKING EVALUATION FROM AN URGENT CARE FACILITY FOR SKIN IRRITATION CHARACTERIZED BY ITCHING AT THE ZIO MONITOR DEVICE APPLICATION SITE. THE PATIENT WAS DIAGNOSED WITH AN ALLERGIC REACTION AND WAS PRESCRIBED METHYLPREDNISONE.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 25331269 ↗InjuryMay 21, 2026Patient-Device Incompatibility
THE PATIENT REPORTED SKIN IRRITATION TO THEIR HEALTHCARE PROVIDER (HCP) ALLEGEDLY CAUSED BY THE ZIO MONITOR. THE PATIENT REPORTED EXPERIENCING ITCHING, REDNESS AND SWELLING AT THE APPLICATION SITE. DESPITE THE REACTION THE PATIENT COMPLETED THE ENTIRE PRESCRIBED WEAR PERIOD. THE HCP PRESCRIBED UNSPECIFIED STEROID TREATMENT FOR THE REACTION.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 25240500 ↗InjuryMay 19, 2026Patient-Device Incompatibility
THE PATIENT REPORTED SEEKING EVALUATION FROM A HEALTHCARE PROVIDER (HCP) FOR SKIN IRRITATION CHARACTERIZED BY RASH AT THE ZIO MONITOR DEVICE APPLICATION SITE. THE DEVICE WAS REMOVED. ACCORDING TO THE PATIENT, THE HCP PRESCRIBED TRIAMCINOLONE CREAM AS TREATMENT.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 25224888 ↗InjuryMay 19, 2026Patient-Device Incompatibility
THE PATIENT REPORTED SEEKING EVALUATION FROM A HEALTHCARE PROVIDER FOR SKIN IRRITATION AT THE ZIO MONITOR DEVICE APPLICATION SITE. THE PATIENT EXPERIENCED ITCHING, PAIN AND A SENSATION IN THEIR NECK. THE DEVICE WAS REMOVED. ACCORDING TO THE PATIENT, THE HEALTHCARE PROVIDER DIAGNOSED THE CONDITION AS A SKIN ALLERGY AND PRESCRIBED TRIAMCINOLONE ACETONIDE CREAM AS TREATMENT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 25224884 ↗InjuryMay 18, 2026Patient-Device Incompatibility
THE PATIENT REPORTED SEEKING EVALUATION FROM A HEALTHCARE PROVIDER (HCP) FOR ITCHING, BLISTERS AND ALLEGED SCARRING AT THE ZIO MONITOR DEVICE APPLICATION SITE. THE DEVICE WAS REMOVED AND DISCARDED. ACCORDING TO THE PATIENT, THEIR HCP PRESCRIBED TRIAMCINOLONE ACETONIDE CREAM.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 25210590 ↗InjuryMay 18, 2026Patient-Device Incompatibility
THE PATIENT REPORTED SEEKING EVALUATION FROM A DERMATOLOGIST FOR SKIN IRRITATION AT THE ZIO MONITOR DEVICE APPLICATION SITE. THE SYMPTOMS INCLUDED ITCHING, REDNESS, AND A BURNING SENSATION, ALONG WITH WELTS AND HIVES EXTENDING FROM THE CHEST TO THE NECK. A BIOPSY WAS PERFORMED, AND THE PATIENT TESTED POSITIVE FOR STENOTROPHOMONAS MALTOPHILIA. THE PATIENT WAS PRESCRIBED LEVOFLOXACIN TABLETS AND TRIAMCINOLONE ACETONIDE CREAM AS TREATMENT.
Patient problems: Skin Infection
MAUDE report 25210589 ↗InjuryMay 12, 2026Patient-Device Incompatibility
THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER (HCP) WITH SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO MONITOR. THE PATIENT REPORTED REDNESS, ITCHING, HIVES, DISCOMFORT, SWELLING, AND BLISTERING AT AND AROUND THE ADHESIVE APPLICATION SITE. PRIOR TO THE CLINIC VISIT, THE PATIENT APPLIED A COLD COMPRESS TO THE AFFECTED AREA, WHICH PROVIDED TEMPORARY RELIEF. THE PATIENT WAS SUBSEQUENTLY EVALUATED BY AN HCP AND PRESCRIBED A TOPICAL STEROID CREAM FOR TREATMENT.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 25148602 ↗InjuryMay 11, 2026Patient-Device Incompatibility
A PATIENT SOUGHT EVALUATION FROM A HEALTHCARE PROVIDER (HCP) FOR SKIN IRRITATION AT THE ZIO MONITOR DEVICE APPLICATION SITE. THE PATIENT HAD EXPERIENCED ITCHING, REDNESS, BLISTERS AND HIVES. THE PATIENT WAS ADMINISTERED BENADRYL. IN ADDITION, THEY WERE PRESCRIBED PREDNISONE AND HYDROXYZINE HCL AS TREATMENT.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 25144623 ↗InjuryMay 8, 2026Patient-Device Incompatibility
THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER (HCP) WITH SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO MONITOR. THE PATIENT REPORTED EXPERIENCING A RASH, ITCHING AND REDNESS AT THE APPLICATION SITE. THE DEVICE WAS REMOVED. THE PATIENT REPORTED BEING EVALUATED BY THE HCP AND PRESCRIBED KETOCONAZOLE AND HYDROCORTISONE CREAMS FOR TREATMENT.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 25129254 ↗InjuryMay 8, 2026Patient-Device Incompatibility
THE PATIENT PRESENTED TO THE USER FACILITY WITH SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO MONITOR. THE PATIENT EXPERIENCED A BURNING SENSATION AND REACTION AT THE APPLICATION SITE. THE DEVICE WAS SUBSEQUENTLY REMOVED. THE PATIENT REPORTED BEING EVALUATED BY A HEALTHCARE PROVIDER (HCP), WHO DIAGNOSED AN ALLERGIC REACTION. THE HCP PRESCRIBED STEROIDS AND ANTIBIOTICS FOR TREATMENT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 25128302 ↗InjuryMay 7, 2026Patient-Device Incompatibility
THE PATIENT PRESENTED URGENT CARE WITH SKIN IRRITATION, ALLEGEDLY CAUSED BY THE ZIO MONITOR. THE PATIENT REPORTED THEY EXPERIENCED BLISTERS AT THE APPLICATION SITE. THE DEVICE WAS SUBSEQUENTLY REMOVED. DURING THE URGENT CARE VISIT, THE PATIENT WAS EVALUATED BY A HEALTHCARE PROVIDER (HCP) AND DIAGNOSED WITH CONTACT DERMATITIS. THE HCP PRESCRIBED PREDNISONE FOR TREATMENT.
Patient problems: Contact Dermatitis
MAUDE report 25118030 ↗InjuryMay 7, 2026Patient-Device Incompatibility
THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER (HCP) WITH SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO MONITOR. THE PATIENT REPORTED THEY EXPERIENCED ITCHING, SORES AND DISCOMFORT AT THE APPLICATION SITE. THE DEVICE WAS SUBSEQUENTLY REMOVED. FOLLOWING EXAMINATION, THE HCP DIAGNOSED AN ALLERGIC REACTION AND PRESCRIBED TRIAMCINOLONE CREAM FOR TREATMENT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 25118008 ↗InjuryMay 7, 2026Use of Device Problem
THE PATIENT REPORTED SKIN IRRITATION THAT OCCURRED DURING THE SKIN PREPARATION PROCESS FOR THE ZIO MONITOR DEVICE. DURING SKIN PREPARATION, THE PATIENT SHAVED AND EXFOLIATED OVER PRE-EXISTING ACNE, RESULTING IN BLEEDING, REDNESS, AND BUMPS. ACCORDING TO THE PATIENT, THEY TREATED WITH OVER-THE-COUNTER NEOSPORIN AND LATER PRESENTED TO A DERMATOLOGIST IN WHICH THEY WERE PRESCRIBED TRIAMCINOLONE ACETONIDE. THE DEVICE WAS APPLIED A WEEK LATER WITHOUT FURTHER REPORTED SKIN IRRITATION.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 25117048 ↗InjuryMay 7, 2026Patient-Device Incompatibility
THE PATIENT REPORTED SEEKING EVALUATION FROM A DERMATOLOGIST FOR SKIN IRRITATION AT THE ZIO MONITOR DEVICE APPLICATION SITE. THE PATIENT EXPERIENCED REDNESS, INFLAMMATION, PEELING SKIN, RAWNESS, SECRETIONS AND A BURNING SENSATION. THE PATIENT BELIEVED THE IRRITATION WAS DUE TO ROUGH EXFOLIATION. ACCORDING TO THE PATIENT, THEY WERE DIAGNOSED WITH CONTACT DERMATITIS AND A SURFACE BURN. THE PATIENT WAS PRESCRIBED HYDROCORTISONE AND FLUOCINONIDE OINTMENT.
Patient problems: Burn(s); Contact Dermatitis
MAUDE report 25117044 ↗InjuryMay 1, 2026Patient-Device Incompatibility
A REPRESENTATIVE FROM THE ACCOUNT REPORTED A PATIENT SEEKING EVALUATION FROM A HEALTHCARE PROVIDER FOR AN ALLERGIC REACTION ASSOCIATED TO THE ZIO MONITOR DEVICE. THE PATIENT EXPERIENCED A RASH THAT BEGAN AT THE DEVICE APPLICATION SITE AND SPREAD ACROSS THEIR UPPER BODY AND ARMS. THE PATIENT WAS DIAGNOSED WITH CONTACT DERMATITIS AND PRESCRIBED PREDNISONE AND TRIAMCINOLONE CREAM.
Patient problems: Contact Dermatitis
MAUDE report 25055763 ↗InjuryApr 30, 2026Patient-Device Incompatibility
THE PATIENT REPORTED SEEKING EVALUATION FROM THEIR HEALTHCARE PROVIDER (HCP) FOR SIGNS OF AN ALLERGIC REACTION CHARACTERIZED BY ITCHING, REDNESS AND SECRETIONS AT THE ZIO MONITOR DEVICE APPLICATION SITE. THE PATIENT WAS INITIALLY ADVISED TO TREAT WITH ANTIHISTAMINES, HOWEVER THE IRRITATION PERSISTED. SUBSEQUENTLY, THE PATIENT PRESENTED TO AN URGENT CARE FACILITY WHERE THE DEVICE WAS REMOVED AND THEY WERE DIAGNOSED WITH CONTACT DERMATITIS. THE PATIENT WAS PRESCRIBED TRIAMCINOLONE STEROID CREAM.
Patient problems: Contact Dermatitis
MAUDE report 25043370 ↗InjuryApr 29, 2026Patient-Device Incompatibility
THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER (HCP) WITH SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO MONITOR. THE PATIENT EXPERIENCED ITCHING AT THE APPLICATION SITE. THE DEVICE WAS REMOVED. THE PATIENT REPORTED BEING EVALUATED BY AN HCP, WHO DIAGNOSED AN ALLERGIC REACTION AND PRESCRIBED PREDNISONE TO TREAT THE REACTION.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 25037791 ↗InjuryApr 29, 2026Patient-Device Incompatibility
THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER (HCP) WITH SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO MONITOR. THE PATIENT EXPERIENCED ITCHING, REDNESS, BLISTERS AND A AND A BURNING SENSATION AT THE APPLICATION SITE. THE DEVICE WAS REMOVED. THE PATIENT REPORTED BEING EVALUATED BY AN HCP, WHO PRESCRIBED TRIAMCINOLONE ACETONIDE TO TREAT THE REACTION.
Patient problems: Blister; Skin Inflammation/ Irritation
MAUDE report 25037790 ↗InjuryApr 29, 2026Patient-Device Incompatibility
THE PATIENT REPORTED SEEKING EVALUATION FROM A HEALTHCARE PROVIDER FOR SIGNS OF AN ALLERGIC REACTION CHARACTERIZED BY ITCHING, REDNESS AND A RASH AT THE ZIO MONITOR DEVICE APPLICATION SITE. ACCORDING TO THE PATIENT, THE HEALTHCARE PROVIDER DIAGNOSED THE CONDITION AS CONTACT DERMATITIS AND PRESCRIBED TRIAMCINOLONE ACETONIDE CREAM AND AN ANTIHISTAMINE.
Patient problems: Contact Dermatitis
MAUDE report 25027694 ↗InjuryApr 28, 2026Patient-Device Incompatibility
THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER (HCP) WITH SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO MONITOR. THE PATIENT EXPERIENCED ITCHING, REDNESS AND BLISTERS AT THE APPLICATION SITE. THE PATIENT TREATED WITH OVER COUNTER BENADRYL, WITH NO RELIEF. THE DEVICE WAS REMOVED. FOLLOWING EXAMINATION, THE HCP DIAGNOSED CONTACT DERMATITIS AND PRESCRIBED A TOPICAL OINTMENT FOR TREATMENT.
Patient problems: Contact Dermatitis
MAUDE report 25017001 ↗InjuryApr 27, 2026Patient-Device Incompatibility
THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH SKIN IRRITATION, ALLEGEDLY CAUSED BY THE ZIO MONITOR. THE PATIENT EXPERIENCED A RASH AND ITCHING AT THE APPLICATION SITE. WHILE AT THE ER THE PATIENT REPORTED BEING EVALUATED BY A HEALTHCARE PROVIDER, WHO PRESCRIBED AN UNSPECIFIED MEDICATION.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 24999737 ↗
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- ePatch 2.0 BTI 02-01650Braemar Manufacturing, LLC · Recorder, Magnetic Tape, Medical2 reports
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- Epatch 2.0 02-01575Braemar Manufacturing, LLC · Recorder, Magnetic Tape, Medical1 report
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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