ZOLL PatchRecalls & reported problems

Summary

The FDA's MAUDE database contains 213 adverse event reports that list this exact device (DI 00855778005258), received between Oct 24, 2019 and May 20, 2022 — classified as 213 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (31 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 213 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem

  A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT THE PATIENT DEVELOPED A RED ITCHY SKIN IRRITATION FROM THE UCOR HFAMS PATCH. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT'S PHYSICIAN ADVISED THE PATIENT TO REMOVE THE DEVICE DUE TO DISCOMFORT AND SKIN IRRITATION. OUTCOME OF THE SKIN IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 14464253 ↗
• InjuryMay 18, 2022Adverse Event Without Identified Device or Use Problem

  ZOLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED RED RASH UNDER THE HYDROGEL CIRCLES. 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 RASH IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 14429791 ↗
• InjuryMay 18, 2022Adverse Event Without Identified Device or Use Problem

  ZOLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A RED, BURNING SORE UNDER THE HYDROGEL CIRCLES. 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 RASH IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 14429772 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use 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 BROKEN, BRUISING, AND BURNING SKIN IRRITATION. 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 14378923 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem

  ZOLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED BLEEDING, BURNING BLISTERS UNDER THE HYDROGEL CIRCLES. THE PATIENT REPORTED BROKEN SKIN. THE PATIENT REPORTED REACHING OUT TO PHYSICIAN, BUT THERE IS NO INDICATION OF MEDICAL INTERVENTION. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. OUTCOME OF THE IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 14280622 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use 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, BROKEN AND BURNING. 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. OUTCOME OF THE SKIN IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 14280454 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use 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 BROKEN, BLEEDING AND BURNING. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT'S PHYSICIAN ADVISED THE PATIENT TO REMOVE THE DEVICE DUE TO DISCOMFORT AND SKIN IRRITATION. OUTCOME OF THE SKIN IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 14196347 ↗
• InjuryApr 18, 2022Adverse Event Without Identified Device or Use Problem

  ZOLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A BLEEDING, BROKEN SKIN IRRITATION UNDER THE HYDROGEL CIRCLES. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THERE IS NO INDICATION THAT THE PATIENT RECEIVED MEDICAL INTERVENTION. THE MEDICAL OUTCOME IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 14137168 ↗
• InjuryApr 18, 2022Adverse Event Without Identified Device or Use 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 WEEPING, BURNING 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 14137167 ↗
• InjuryApr 18, 2022Adverse Event Without Identified Device or Use 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 WELTS WITH BLEEDING, BROKEN SKIN. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT'S PHYSICIAN ADVISED THE PATIENT TO SWITCH TO A DIFFERENT DEVICE DUE TO THE SKIN IRRITATION. OUTCOME OF THE SKIN IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 14137165 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use 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 BURNING BLISTERS. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT'S PHYSICIAN ADVISED THE PATIENT TO REMOVE THE DEVICE DUE TO DISCOMFORT AND SKIN IRRITATION. OUTCOME OF THE SKIN IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 14076767 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use 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, BROKEN AND BURNING. 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 14076727 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use 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, BLEEDING, BROKEN, 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 14076723 ↗
• InjuryApr 5, 2022Patient-Device Incompatibility

  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, RAISED WITH BROKEN SKIN 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 14015463 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use 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 BURNING. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT'S PHYSICIAN PRESCRIBED A CREAM FOR THE SKIN IRRITATION. OUTCOME OF THE SKIN IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13932311 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use 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 BURNING. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT'S PHYSICIAN ADVISED THE PATIENT TO END USE AND RETURN THE DEVICE. OUTCOME OF THE SKIN IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13932206 ↗
• InjuryMar 26, 2022Adverse Event Without Identified Device or Use Problem

  ZOLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED BROKEN, OPEN SKIN IRRITATION UNDER THE HYDROGEL CIRCLES. 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 13921147 ↗
• InjuryMar 25, 2022Patient-Device Incompatibility

  A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT THE PATIENT'S PATCH PULLED ON THEIR MOLES AND CAUSED A BLEEDING, BROKEN SKIN IRRITATION. 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 13904876 ↗
• InjuryMar 24, 2022Patient-Device Incompatibility

  A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT THE PATIENT DEVELOPED A BLEEDING, ITCHY, RED SKIN IRRITATION FROM THE UCOR HFAMS PATCH. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT'S PHYSICIAN ADVISED THE PATIENT TO REMOVE THE DEVICE DUE TO DISCOMFORT AND SKIN IRRITATION. OUTCOME OF THE SKIN IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13892413 ↗
• InjuryMar 20, 2022Adverse Event Without Identified Device or Use Problem

  ZOLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A SKIN IRRITATION UNDER THE HYDROGEL CIRCLES. THE PATIENT REPORTED BURNING, BROKEN SKIN. 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 13829498 ↗
• InjuryMar 11, 2022Adverse Event Without Identified Device or Use 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 BURNING. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT REPORTED REACHING OUT TO PHYSICIAN AND ENDED USE OF THE DEVICE DUE TO THE SKIN IRRITATION. IT IS UNCLEAR IF THE PATIENT WAS ADVISED TO REMOVE THE DEVICE BY THE PHYSICIAN. REPORTING OUT OF ABUNDANCE OF CAUTION. OUTCOME OF THE SKIN IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13737439 ↗
• InjuryMar 11, 2022Adverse Event Without Identified Device or Use Problem

  A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT THE PATIENT DEVELOPED A RED ITCHY RASH FROM THE HYDROGEL CIRCLES. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT'S PHYSICIAN ADVISED THE PATIENT TO REMOVE THE DEVICE DUE TO DISCOMFORT AND SKIN IRRITATION. OUTCOME OF THE SKIN IRRITATION IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13737416 ↗
• InjuryMar 11, 2022Patient-Device Incompatibility

  ZOLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A RED STINGING SKIN IRRITATION UNDER THE HYDROGEL CIRCLES. 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 13737377 ↗
• InjuryMar 9, 2022Adverse Event Without Identified Device or Use Problem

  ZOLL LABORATORY SERVICES CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED RED ITCHY BLISTERS UNDER THE HYDROGELS. 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 RASH IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13713458 ↗
• InjuryMar 3, 2022Adverse Event Without Identified Device or Use 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 BLEEDING AND BROKEN. 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 13661023 ↗