ZIO AT Patch A100A100XRecalls & reported problems

Summary

The FDA's MAUDE database contains 629 adverse event reports that list this exact device (DI 00869770000210), received between Aug 14, 2018 and Aug 28, 2026 — classified as 14 deaths, 79 injuries, 536 malfunctions.

The most frequently reported specific device problem is “Failure to Transmit Record” (524 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. Sep 28, 2022Open, Classified

   Ambulatory ECG monitoring system labeling update: 1) Clinically actionable arrhythmia notifications delayed until patient registration is complete; 2) Patches limited to 100 symptomatic and 500 asymptomatic wireless transmissions; once the maximum transmission limit is reached for either type, any further transmissions for that type will cease. Risk of delayed reporting to health providers.

   Z-0183-2023 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 629 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Failure to Transmit Record

  Patient problems: Unspecified Heart Problem

  MAUDE report 50501485 ↗
• MalfunctionJul 10, 2026Failure to Transmit Record

  Patient problems: Unspecified Heart Problem

  MAUDE report 25781550 ↗
• MalfunctionJun 30, 2026Failure to Transmit Record

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT TRANSMITTED DURING THE WEAR PERIOD. THE INVESTIGATION CONFIRMED THE ZIO AT REACHED THE ASYMPTOMATIC MAXIMUM TRANSMISSION LIMIT. THE HCP ACCOUNT WAS NOTIFIED THAT THE DEVICE WAS APPROACHING THE ASYMPTOMATIC TRANSMISSION LIMIT PRIOR TO REACHING THE LIMIT, ACCORDING TO THE STANDARD PROCESS, AND A REPLACEMENT DEVICE WAS SHIPPED. NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 25667286 ↗
• MalfunctionJun 26, 2026Failure to Transmit Record

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT TRANSMITTED DURING THE WEAR PERIOD. THE INVESTIGATION CONFIRMED THE ZIO AT REACHED THE ASYMPTOMATIC MAXIMUM TRANSMISSION LIMIT. THE HEALTHCARE PROVIDER (HCP) ACCOUNT WAS NOTIFIED THAT THE DEVICE WAS APPROACHING THE ASYMPTOMATIC TRANSMISSION LIMIT PRIOR TO REACHING THE LIMIT, ACCORDING TO THE STANDARD PROCESS, AND A REPLACEMENT DEVICE WAS SHIPPED. NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 25638965 ↗
• MalfunctionJun 25, 2026Failure to Transmit Record

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT TRANSMITTED DURING THE WEAR PERIOD. THE INVESTIGATION CONFIRMED THE ZIO AT REACHED THE ASYMPTOMATIC MAXIMUM TRANSMISSION LIMIT. THE HCP ACCOUNT WAS NOTIFIED THAT THE DEVICE WAS APPROACHING THE ASYMPTOMATIC TRANSMISSION LIMIT PRIOR TO REACHING THE LIMIT, ACCORDING TO THE STANDARD PROCESS, AND A REPLACEMENT DEVICE WAS SHIPPED. IRHYTHM NOTIFIED THE HEALTHCARE PROVIDER (HCP) OF THE PATIENT¿S ARRYTHMIA VIA FINAL REPORT. NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 25619211 ↗
• MalfunctionJun 18, 2026Failure to Transmit Record

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT TRANSMITTED DURING THE WEAR PERIOD. THE INVESTIGATION CONCLUDED THAT THE ARRHYTHMIA WAS NOT TRANSMITTED DURING WEAR DUE TO A LOW BATTERY IN THE GATEWAY. IRHYTHM NOTIFIED THE HEALTHCARE PROVIDER (HCP) OF THE PATIENT¿S ARRYTHMIA. NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 25552617 ↗
• MalfunctionJun 18, 2026Failure to Transmit Record

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT TRANSMITTED DURING THE WEAR PERIOD. THE INVESTIGATION CONFIRMED THE ZIO AT REACHED THE ASYMPTOMATIC MAXIMUM TRANSMISSION LIMIT. THE HEALTHCARE PROVIDER (HCP) ACCOUNT WAS NOTIFIED THAT THE DEVICE WAS APPROACHING THE ASYMPTOMATIC TRANSMISSION LIMIT PRIOR TO REACHING THE LIMIT, ACCORDING TO THE STANDARD PROCESS, AND A REPLACEMENT DEVICE WAS SHIPPED. ADDITIONAL FOLLOW-UP WAS PERFORMED WITH THE ACCOUNT TO NOTIFY OF THE PATIENT'S ARRHYTHMIA. THERE WERE NO DELAYS IN TREATMENT, AND NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 25548242 ↗
• InjuryMay 21, 2026Patient-Device Incompatibility

  THE PRESENTED TO URGENT CARE WITH SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO AT. THE PATIENT REPORTED EXPERIENCING A SPREADING RASH, ITCHING AND HIVES. THE PATIENT STATED THAT THEY REMOVED THE DEVICE AND OBSERVED BLEEDING AT THE APPLICATION SITE. THE PATIENT WAS EVALUATED BY A HEALTHCARE PROVIDER (HCP) AT URGENT CARE, WHERE THEY RECEIVED A STEROID INJECTION AND WERE PRESCRIBED TOPICAL CORTISONE CREAM FOR TREATMENT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 25240504 ↗
• InjuryMay 21, 2026Patient Data Problem

  THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER (HCP) WITH SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO AT. THE PATIENT REPORTED EXPERIENCING A RASH, ITCHING, REDNESS AND A WARM SENSATION AT THE APPLICATION SITE. THE DEVICE WAS REMOVED. THE HCP DIAGNOSED AN ALLERGIC REACTION AND PRESCRIBED TRIAMCINOLONE ACETONIDE FOR TREATMENT.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 25240503 ↗
• MalfunctionMay 19, 2026Failure to Transmit Record

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT TRANSMITTED DURING THE WEAR PERIOD. THE INVESTIGATION CONFIRMED THE ZIO AT REACHED THE ASYMPTOMATIC MAXIMUM TRANSMISSION LIMIT. THE HEALTHCARE PROVIDER (HCP) ACCOUNT WAS NOTIFIED THAT THE DEVICE WAS APPROACHING THE ASYMPTOMATIC TRANSMISSION LIMIT PRIOR TO REACHING THE LIMIT, ACCORDING TO THE STANDARD PROCESS, AND A REPLACEMENT DEVICE WAS SHIPPED. ADDITIONAL FOLLOW-UP WAS PERFORMED WITH THE ACCOUNT TO NOTIFY OF THE PATIENT'S ARRHYTHMIA. THERE WERE NO DELAYS IN TREATMENT, AND NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 25224885 ↗
• InjuryMay 8, 2026Patient-Device Incompatibility

  THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO AT. THE PATIENT¿S SON REPORTED THAT THE PATIENT DEVELOPED A RASH AT THE APPLICATION SITE. THE DEVICE WAS SUBSEQUENTLY REMOVED. WHILE IN THE ER, THE PATIENT WAS EVALUATED BY A HEALTHCARE PROVIDER (HCP), WHO DIAGNOSED AN ALLERGIC REACTION AND PRESCRIBED AN UNSPECIFIED TOPICAL CREAM FOR TREATMENT.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 25128641 ↗
• InjuryApr 29, 2026Patient-Device Incompatibility

  THE PATIENT REPORTED SEEKING EVALUATION FROM A HEALTHCARE PROVIDER FOR ITCHING, REDNESS, PAIN, BURNING SENSATION AND A RASH AT THE ZIO AT DEVICE APPLICATION SITE. THE DEVICE WAS REMOVED. ACCORDING TO THE PATIENT, THE HCP PRESCRIBED AN UNSPECIFIED MEDICATION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 25031921 ↗
• InjuryApr 29, 2026Patient-Device Incompatibility

  THE PATIENT REPORTED SEEKING EVALUATION FROM AN URGENT CARE FACILITY FOR A BURN AND ALLERGIC REACTION ALLEGEDLY CAUSED BY THE ZIO AT DEVICE. THE PATIENT DESCRIBED REDNESS, ITCHING, PAIN AND A BURNING SENSATION AT THE DEVICE APPLICATION SITE, ATTRIBUTING THE BURNING SENSATION TO THE DEVICE BATTERY. ACCORDING TO THE PATIENT, THE HEALTHCARE PROVIDER DIAGNOSED THE CONDITION AS EITHER CONTACT DERMATITIS OR A POSSIBLE BURN. THE PATIENT WAS PRESCRIBED SILVER SULFADIAZINE CREAM TO TREAT THE AFFECTED AREA.

  Patient problems: Contact Dermatitis

  MAUDE report 25028076 ↗
• MalfunctionApr 29, 2026Failure to Transmit Record

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT TRANSMITTED DURING THE WEAR PERIOD. THE INVESTIGATION CONFIRMED THE ZIO AT REACHED THE ASYMPTOMATIC MAXIMUM TRANSMISSION LIMIT. THE HEALTHCARE PROVIDER (HCP) ACCOUNT WAS NOTIFIED THAT THE DEVICE WAS APPROACHING THE ASYMPTOMATIC TRANSMISSION LIMIT PRIOR TO REACHING THE LIMIT, ACCORDING TO THE STANDARD PROCESS, AND A REPLACEMENT DEVICE WAS OFFERED BUT DECLINED. ADDITIONAL FOLLOW-UP WAS PERFORMED WITH THE ACCOUNT TO NOTIFY OF THE PATIENT'S ARRHYTHMIA. THERE WERE NO DELAYS IN TREATMENT, AND NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 25027695 ↗
• MalfunctionApr 24, 2026Failure to Transmit Record

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) CRITERIA; HOWEVER, THE EVENT WAS NOT TRANSMITTED DURING THE WEAR PERIOD. THE INVESTIGATION DETERMINED THAT THE GATEWAY PREMATURELY STOPPED TRANSMITTING NEW DATA. THE HEALTHCARE PROVIDER (HCP) WAS NOTIFIED OF THE PATIENT¿S ARRHYTHMIA. NO DELAYS IN PATIENT TREATMENT WERE REPORTED, AND NO ADVERSE EVENTS, INCLUDING DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 24980561 ↗
• InjuryApr 20, 2026Patient-Device Incompatibility

  THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER (HCP) WITH SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO AT. THE PATIENT EXPERIENCED ITCHING AT THE APPLICATION SITE. THE DEVICE WAS REMOVED FROM THE PATIENT¿S LEFT SIDE. DESPITE THE REACTION, THE HCP APPLIED A SECOND ZIO AT ON THE OPPOSITE SIDE OF PATIENT¿S CHEST AND PRESCRIBED BENADRYL TO TREAT THE REACTION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24932718 ↗
• MalfunctionApr 16, 2026Failure to Transmit Record

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT TRANSMITTED DURING THE WEAR PERIOD. THE INVESTIGATION CONFIRMED THE ZIO AT REACHED THE ASYMPTOMATIC MAXIMUM TRANSMISSION LIMIT. THE HEALTHCARE PROVIDER (HCP) ACCOUNT WAS NOTIFIED THAT THE DEVICE WAS APPROACHING THE ASYMPTOMATIC TRANSMISSION LIMIT PRIOR TO REACHING THE LIMIT, ACCORDING TO THE STANDARD PROCESS, AND A REPLACEMENT DEVICE WAS SHIPPED. ADDITIONAL FOLLOW-UP WAS PERFORMED WITH THE ACCOUNT TO NOTIFY OF THE PATIENT'S ARRHYTHMIA. THERE WERE NO DELAYS IN TREATMENT, AND NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 24895347 ↗
• MalfunctionApr 13, 2026Patient-Device Incompatibility

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT TRANSMITTED DURING THE WEAR PERIOD. THE INVESTIGATION CONFIRMED THE ZIO AT REACHED THE ASYMPTOMATIC MAXIMUM TRANSMISSION LIMIT. THE HCP ACCOUNT WAS NOTIFIED THAT THE DEVICE WAS APPROACHING THE ASYMPTOMATIC TRANSMISSION LIMIT PRIOR TO REACHING THE LIMIT, ACCORDING TO THE STANDARD PROCESS, AND A REPLACEMENT DEVICE WAS SHIPPED. NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 24867257 ↗
• MalfunctionApr 10, 2026Failure to Transmit Record

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT TRANSMITTED DURING THE WEAR PERIOD. THE INVESTIGATION CONFIRMED THE ZIO AT REACHED THE ASYMPTOMATIC MAXIMUM TRANSMISSION LIMIT. THE HEALTHCARE PROVIDER (HCP) ACCOUNT WAS NOTIFIED THAT THE DEVICE WAS APPROACHING THE ASYMPTOMATIC TRANSMISSION LIMIT PRIOR TO REACHING THE LIMIT, ACCORDING TO THE STANDARD PROCESS, AND A REPLACEMENT DEVICE WAS SHIPPED. ADDITIONAL FOLLOW-UP WAS PERFORMED WITH THE ACCOUNT TO NOTIFY OF THE PATIENT'S ARRHYTHMIA. THERE WERE NO DELAYS IN TREATMENT, AND NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 24845052 ↗
• MalfunctionApr 9, 2026Failure to Transmit Record

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT TRANSMITTED DURING THE WEAR PERIOD. THE INVESTIGATION CONFIRMED THE ZIO AT REACHED THE ASYMPTOMATIC MAXIMUM TRANSMISSION LIMIT. THE HCP ACCOUNT WAS NOTIFIED THAT THE DEVICE WAS APPROACHING THE ASYMPTOMATIC TRANSMISSION LIMIT PRIOR TO REACHING THE LIMIT, ACCORDING TO THE STANDARD PROCESS, AND A REPLACEMENT DEVICE WAS SHIPPED. NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 24835672 ↗
• MalfunctionApr 3, 2026Failure to Transmit Record

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT TRANSMITTED DURING THE WEAR PERIOD. THE INVESTIGATION CONFIRMED THE ZIO AT REACHED THE ASYMPTOMATIC MAXIMUM TRANSMISSION LIMIT. THE HCP ACCOUNT WAS NOTIFIED THAT THE DEVICE WAS APPROACHING THE ASYMPTOMATIC TRANSMISSION LIMIT PRIOR TO REACHING THE LIMIT, ACCORDING TO THE STANDARD PROCESS, AND A REPLACEMENT DEVICE WAS SHIPPED. NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 24781670 ↗
• MalfunctionApr 3, 2026Failure to Transmit Record

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT TRANSMITTED DURING THE WEAR PERIOD. THE INVESTIGATION CONFIRMED THE ZIO AT REACHED THE ASYMPTOMATIC MAXIMUM TRANSMISSION LIMIT. THE HEALTHCARE PROVIDER (HCP) ACCOUNT WAS NOTIFIED THAT THE DEVICE WAS APPROACHING THE ASYMPTOMATIC TRANSMISSION LIMIT PRIOR TO REACHING THE LIMIT, ACCORDING TO THE STANDARD PROCESS, AND A REPLACEMENT DEVICE WAS SHIPPED. ADDITIONAL FOLLOW-UP WAS PERFORMED WITH THE ACCOUNT TO NOTIFY OF THE PATIENT'S ARRHYTHMIA. THERE WERE NO DELAYS IN TREATMENT, AND NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 24781607 ↗
• MalfunctionApr 3, 2026Failure to Transmit Record

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT TRANSMITTED DURING THE WEAR PERIOD. THE INVESTIGATION CONFIRMED THE ZIO AT REACHED THE ASYMPTOMATIC MAXIMUM TRANSMISSION LIMIT. THE HCP ACCOUNT WAS NOTIFIED THAT THE DEVICE WAS APPROACHING THE ASYMPTOMATIC TRANSMISSION LIMIT PRIOR TO REACHING THE LIMIT, ACCORDING TO THE STANDARD PROCESS, AND A REPLACEMENT DEVICE WAS SHIPPED. NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 24776604 ↗
• InjuryApr 3, 2026Patient-Device Incompatibility

  THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER WITH A SKIN IRRITATION ALLEGEDLY CAUSED BY THE ZIO AT. THE PATIENT EXPERIENCED A RASH, ITCHING, AND A BURNING SENSATION AT THE APPLICATION SITE. THE DEVICE WAS SUBSEQUENTLY REMOVED. THE PATIENT WAS EVALUATED BY A HEALTHCARE PROVIDER, WHO CONFIRMED THE PRESENCE OF A RASH AND PRESCRIBED TRIAMCINOLONE ACETONIDE CREAM FOR TREATMENT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24776603 ↗
• MalfunctionMar 24, 2026Failure to Transmit Record

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT TRANSMITTED DURING THE WEAR PERIOD. THE INVESTIGATION CONFIRMED THE ZIO AT REACHED THE ASYMPTOMATIC MAXIMUM TRANSMISSION LIMIT. THE HEALTHCARE PROVIDER (HCP) ACCOUNT WAS NOTIFIED THAT THE DEVICE WAS APPROACHING THE ASYMPTOMATIC TRANSMISSION LIMIT PRIOR TO REACHING THE LIMIT, ACCORDING TO THE STANDARD PROCESS, AND A REPLACEMENT DEVICE WAS OFFERED BUT DECLINED. THE HCP ACCOUNT WAS NOTIFIED OF THE PATIENT'S ARRHYTHMIA VIA FINAL REPORT. THERE WERE NO DELAYS IN TREATMENT, AND NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 24676850 ↗