ZOLL Arrhythmia Management System SensorRecalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00855778005357), received between Oct 2, 2024 and Sep 16, 2025 — classified as 41 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (41 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 41 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ZOLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A BROKEN SKIN IRRITATION UNDER THE PATCH. THE PATIENT DESCRIBED THE AREA AS AN OPEN WOUND THAT IS RED, RAISED, BURNING, AND ITCHY UNDER THE PATCH AREA. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THERE IS NO INDICATION THAT THE PATIENT RECEIVED MEDICAL INTERVENTION. THE PATIENT'S PHYSICIAN RECOMMENDED REMOVAL OF THE PATCH DUE TO THE SKIN IRRITATION. THE OUTCOME OF THE IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 23064860 ↗
• InjurySep 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ZOLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A BROKEN SKIN IRRITATION UNDER THE PATCH. THE PATIENT DESCRIBED THE AREA AS RED, ITCHY, BLEEDING OPEN WOUND. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT'S ADVISED PATIENT MAY RETURN, OR ASK IF WE HAD ANY ALTERNATE PATCHES FOR SENSITIVE SKIN. THE OUTCOME OF THE IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 23036066 ↗
• InjurySep 8, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ZOLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A BROKEN SKIN IRRITATION UNDER THE PATCH. THE PATIENT DESCRIBED THE AREA AS RED BLEEDING OPEN WOUND. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THERE IS NO INDICATION THAT THE PATIENT RECEIVED MEDICAL INTERVENTION. THE OUTCOME OF THE IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22990965 ↗
• InjurySep 8, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ZOLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A BROKEN SKIN IRRITATION UNDER THE PATCH. THE PATIENT DESCRIBED THE AREA AS RED, ITCHY BROKEN SKIN. THE PATIENT STATED THEY DO HAVE A HISTORY OF SENSITIVE SKIN AND /OR ALLERGIES. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THERE IS NO INDICATION THAT THE PATIENT RECEIVED MEDICAL INTERVENTION. THE OUTCOME OF THE IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22990864 ↗
• InjuryAug 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ZOLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A BROKEN SKIN IRRITATION UNDER THE PATCH. THE PATIENT DESCRIBED THE AREA AS RED ITCHY BROKEN SKIN. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THERE IS NO INDICATION THAT THE PATIENT RECEIVED MEDICAL INTERVENTION. THE OUTCOME OF THE IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22888160 ↗
• InjuryAug 1, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ZOLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A SKIN IRRITATION UNDER THE PATCH. THE PATIENT DESCRIBED THE AREA AS RED AND ITCHY WELTS. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT'S PHYSICIAN RECOMMENDED REMOVAL OF THE PATCH DUE TO THE SKIN IRRITATION. THE OUTCOME OF THE IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22686825 ↗
• InjuryJul 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ZOLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A BROKEN SKIN IRRITATION UNDER THE PATCH. THE PATIENT DESCRIBED THE AREA AS A BLEEDING, BROKEN, AND RED SKIN IRRITATION. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THERE IS NO INDICATION THAT THE PATIENT RECEIVED MEDICAL INTERVENTION. THE OUTCOME OF THE IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22558341 ↗
• InjuryJul 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ZOLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A SKIN IRRITATION UNDER THE PATCH. THE PATIENT DESCRIBED THE AREA AS RED, ITCHY, AND BURNING BLISTERS. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT'S PHYSICIAN ADVISED TO USE VASELINE AND RECOMMENDED REMOVAL OF THE PATCH DUE TO THE SKIN IRRITATION. THE OUTCOME OF THE IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22554114 ↗
• InjuryJul 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT THE PATIENT DEVELOPED AN OPEN WOUND FROM THE UCOR HFAMS PATCH. THE PATIENT DESCRIBED THE AREA AS BLEEDING BLISTER, AND BRUISE. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT REPORTED REACHING OUT TO PHYSICIAN, BUT THERE IS NO INDICATION OF MEDICAL INTERVENTION. THE OUTCOME OF THE SKIN IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22508077 ↗
• InjuryJul 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ZOLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A BROKEN SKIN IRRITATION UNDER THE PATCH. PATIENT DESCRIBED THE AREA AS RED RAISED AND OPEN . THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THERE IS NO INDICATION THAT THE PATIENT RECEIVED MEDICAL INTERVENTION. OUTCOME OF THE IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22459688 ↗
• InjuryJul 8, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ZOLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A BROKEN SKIN IRRITATION UNDER THE PATCH. THE PATIENT DESCRIBED THE AREA AS A BLEEDING, BLISTERED, ITCHY, AND RED SORE. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THERE IS NO INDICATION THAT THE PATIENT RECEIVED MEDICAL INTERVENTION. THE OUTCOME OF THE IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22440208 ↗
• InjuryJun 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ZOLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A BROKEN SKIN IRRITATION UNDER THE PATCH. THE PATIENT DESCRIBED THE AREA AS BURNING ITCHY RED, BLEEDING OPEN BLISTERS. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT'S PHYSICIAN RECOMMENDED REMOVAL OF THE PATCH DUE TO THE SKIN IRRITATION. THE OUTCOME OF THE IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22357090 ↗
• InjuryJun 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ZOLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A SKIN IRRITATION UNDER THE PATCH. PATIENT DESCRIBED THE AREA AS SKIN IRRITATION. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT REPORTED SEEING PHYSICIAN, BUT THERE IS NO INDICATION OF MEDICAL INTERVENTION, REPORTING OUT OF ABUNDANCE OF CAUTION. OUTCOME OF THE IRRITATION IS UNKNOWN AS FOLLOW-UPS WERE UNSUCCESSFUL.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22326899 ↗
• InjuryJun 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ZOLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A BROKEN SKIN IRRITATION UNDER THE PATCH. THE PATIENT DESCRIBED THE AREA AS OPEN SORES, BROKEN SKIN, BLISTERS, RED, BLEEDING, AND BRUISED. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT REPORTED REACHING OUT TO PHYSICIAN, BUT THERE IS NO INDICATION OF MEDICAL INTERVENTION. THE OUTCOME OF THE IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22326529 ↗
• InjuryJun 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT THE PATIENT DEVELOPED BLISTERS FROM THE UCOR HFAMS PATCH. THE PATIENT DESCRIBED THE AREA AS BLISTERS, RED, ITCHING. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT REPORTED REACHING OUT TO PHYSICIAN, BUT THERE IS NO INDICATION OF MEDICAL INTERVENTION. THE OUTCOME OF THE SKIN IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22310026 ↗
• InjuryJun 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT THE PATIENT DEVELOPED A SKIN IRRITATION FROM THE PATCH. PATIENT DESCRIBED THE AREA AS RED AND BURNING UNDER THE PATCH ADHESIVE. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT'S PHYSICIAN RECOMMENDED REMOVAL OF THE PATCH DUE TO THE SKIN IRRITATION. OUTCOME OF THE SKIN IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22202778 ↗
• InjuryJun 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT THE PATIENT DEVELOPED BLISTERS UNDER THE PATCH. PATIENT DESCRIBED THE AREA AS RED BLISTERS UNDER THE PATCH ADHESIVE. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE BLISTERS. THE PATIENT'S PHYSICIAN RECOMMENDED REMOVAL OF THE PATCH DUE TO THE SKIN IRRITATION. OUTCOME OF THE SKIN IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22166495 ↗
• InjuryJun 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ZOLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A BROKEN SKIN IRRITATION UNDER THE PATCH. PATIENT DESCRIBED THE AREA AS RED RAISED AND ITCHY. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT'S PHYSICIAN RECOMMENDED REMOVAL OF THE PATCH DUE TO THE SKIN IRRITATION. OUTCOME OF THE IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22161823 ↗
• InjuryMay 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT THE PATIENT DEVELOPED A SKIN IRRITATION FROM THE UCOR HFAMS PATCH. THE PATIENT DESCRIBED THE AREA AS RED AND RAISED AROUND MOST OF THE PATCH AREA. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT REPORTED REACHING OUT TO PHYSICIAN, BUT THERE IS NO INDICATION OF MEDICAL INTERVENTION. THE OUTCOME OF THE SKIN IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22071178 ↗
• InjuryMay 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ZOLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A BROKEN SKIN IRRITATION UNDER THE PATCH. PATIENT DESCRIBED THE AREA AS OPEN BLISTER. THERE WERE NO ALLEGATIONS OF ANY BLEEDING, OOZING OR WEEPING WOUNDS. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THERE IS NO INDICATION THAT THE PATIENT RECEIVED MEDICAL INTERVENTION. OUTCOME OF THE IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22069929 ↗
• InjuryMay 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT THE PATIENT DEVELOPED AN OPEN WOUND FROM THE UCOR HFAMS PATCH. PATIENT DESCRIBED THE AREA AS ITCHING, REDNESS, BURNING, OPEN AREAS, BLEEDING, AND BLISTERS. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THERE IS NO INDICATION THAT THE PATIENT RECEIVED MEDICAL INTERVENTION. OUTCOME OF THE SKIN IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22026898 ↗
• InjuryMay 14, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT THE PATIENT DEVELOPED AN OPEN WOUND FROM THE UCOR HFAMS PATCH. PATIENT DESCRIBED THE AREA AS BURNING, ITCHING, AND BROKEN SKIN UNDER THE PATCH ADHESIVE. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE WOUND. THERE IS NO INDICATION THAT THE PATIENT RECEIVED MEDICAL INTERVENTION. OUTCOME OF THE WOUND IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22020154 ↗
• InjuryMay 8, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ZOLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A SKIN IRRITATION UNDER THE PATCH. THE PATIENT DESCRIBED THE AREA AS A RED AND ITCHY SKIN IRRITATION. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT'S PHYSICIAN RECOMMENDED CHANGING THE PATCH DUE TO THE SKIN IRRITATION. THE OUTCOME OF THE IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21989078 ↗
• InjuryMay 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ZOLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A BROKEN SKIN IRRITATION UNDER THE PATCH. THE PATIENT DESCRIBED THE AREA AS BROKEN, BRUISED, RED, BURNING, STINGING, AND ITCHY BLISTERS. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THERE IS NO INDICATION THAT THE PATIENT RECEIVED MEDICAL INTERVENTION. THE OUTCOME OF THE IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21967896 ↗
• InjuryMay 5, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT THE PATIENT DEVELOPED A BROKEN SKIN IRRITATION FROM THE UCOR HFAMS PATCH. THE PATIENT DESCRIBED THE AREA AS RED, BROKEN, ITCHY, AND BURNING SKIN IRRITATION. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THERE IS NO INDICATION THAT THE PATIENT RECEIVED MEDICAL INTERVENTION. THE OUTCOME OF THE SKIN IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21960743 ↗