uCor Heart Failure and Arrhythmia Management System SensorRecalls & reported problems
Zoll Manufacturing Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This ZOLL uCor heart failure sensor is a skin patch used to monitor heart failure. Almost all of its 1,067 reports describe skin irritation under the patch, including redness and blisters. The reports include no deaths and 1,067 injuries. Reports rose to 594 in the last 12 months from 435 in the previous 12 months. No recalls name this device.
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
- 1,125
- Deaths reported
- 0
- Injuries reported
- 1,125
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,125 adverse event reports that list this exact device (DI 00855778005302), received between Sep 27, 2024 and Sep 30, 2026 — classified as 1,125 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (1,122 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 Interaction Problem1,122
- Patient-Device Incompatibility1
Patient problems
- Skin Inflammation/ Irritation1,123
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 25 most recent of 1,125 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Patient 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, raised, burning, and itchy under the patch. 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 skin irritation is unknown.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50948179 ↗InjurySep 30, 2026Patient 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 a red skin irritation with burning and stinging sensation around and under the uCor HFAMS Patch. It was reported that the patient has prior history of skin sensitivity or allergies. There was no alleged device malfunction contributing to the irritation. The patient contacted their physician regarding skin irritation, but there is no indication that the physician made any recommendations. However, the patient's nurse recommended removal of the patch due to the skin irritation. The outcome of the skin irritation is unknown.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50944798 ↗InjurySep 29, 2026Patient Device Interaction Problem
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50937929 ↗InjurySep 29, 2026Patient 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 burning and broken skin under the patch adhesive. The patient also reported being on blood thinners. There was no alleged device malfunction contributing to the wound. There is no indication that the patient received medical intervention. The outcome of the wound is unknown.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50937330 ↗InjurySep 28, 2026Patient Device Interaction Problem
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50924032 ↗InjurySep 28, 2026Patient Device Interaction Problem
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50923896 ↗InjurySep 28, 2026Patient Device Interaction Problem
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50923726 ↗InjurySep 28, 2026Patient 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 itchy and big red spots under the hydrogels. There was no alleged device malfunction contributing to the irritation. The patient's physician prescribed medication for skin irritation. The outcome of skin irritation is improved.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50915446 ↗InjurySep 28, 2026Patient 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 broken, red, and itchy blisters. There was no alleged device malfunction contributing to the irritation. The patient's physician prescribed an ointment and recommended temporary removal of the patch due to the skin irritation. The outcome of the skin irritation is unknown.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50914155 ↗InjurySep 28, 2026Patient 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 a red and itchy skin irritation. 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 skin irritation is unknown.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50913774 ↗InjurySep 28, 2026Patient Device Interaction Problem
A US distributor contacted ZOLL to report that the patient developed a broken skin from the uCor HFAMS Patch. The patient described the area as a red and itchy skin irritation around most of the uCor HFAMS Patch area. It was reported that the patient has a history of skin sensitivity irritation or allergies, therefore is using Cortisone Cream on the affected area. There was no alleged device malfunction contributing to the broken skin. There is no indication that the patient received medical intervention. The outcome of the broken skin is unknown.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50913773 ↗InjurySep 25, 2026Patient 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 blisters associated with a burn-like, itchy, and stinging sensation around the uCor HFAMS Patch area. There was no alleged device malfunction contributing to the open wound. 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 50897659 ↗InjurySep 25, 2026Patient 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 a red and burning skin irritation with a sharp pain. There was no alleged device malfunction contributing to the irritation. The patient's nurse recommended removal of the patch due to the skin irritation. The outcome of the skin irritation is unknown.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50896561 ↗InjurySep 25, 2026Patient 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 a red and burning skin irritation. 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 skin irritation is unknown.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50895695 ↗InjurySep 24, 2026Patient Device Interaction Problem
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50890037 ↗InjurySep 24, 2026Patient Device Interaction Problem
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50889901 ↗InjurySep 24, 2026Patient Device Interaction Problem
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50889225 ↗InjurySep 24, 2026Patient Device Interaction Problem
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50876567 ↗InjurySep 23, 2026Patient 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 a red rash. There was no alleged device malfunction contributing to the irritation. The patient's physician recommended a crème for the skin irritation. The outcome of the skin irritation is improved.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50870945 ↗InjurySep 23, 2026Patient 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 broken skin around most of the patch area. 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 50863156 ↗InjurySep 23, 2026Patient Device Interaction Problem
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50863000 ↗InjurySep 22, 2026Patient 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 red, raised, burning, and itching with broken skin localized around the borders of the plastic frame. The patient also reported a known history of sensitive. Skin. There was no alleged device malfunction contributing to the wound. The patient's physician prescribed antibiotic ointment for the wound. The outcome of the wound is unknown.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50854254 ↗InjurySep 22, 2026Patient 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 a red, stinging, and itchy rash with a sharp pain. 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 skin irritation is unknown.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50852192 ↗InjurySep 22, 2026Patient 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 a red, broken, burning, and stinging 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 skin irritation is unknown.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50852063 ↗InjurySep 21, 2026Patient 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 itchy, broken, and bleeding blisters under the hydrogels of the patch. There was no alleged device malfunction contributing to the wound. The patient's physician recommended temporary removal of the patch due to the wound. The outcome of the wound is unknown.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50842937 ↗
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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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