Red Dot™ 2360Recalls & reported problems
3m Company · 3M™ Red Dot™ Resting EKG Electrode 2360 · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00707387472825), received between Apr 26, 2019 and May 3, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Human-Device Interface Problem” (1 report).
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Human-Device Interface Problem1
Patient problems
- Erythema1
- Itching Sensation1
- Rash1
- Skin Tears1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 3, 2023Human-Device Interface Problem; Human-Device Interface Problem
A HOSPITAL REPORTED A PATIENT ALLEGEDLY EXPERIENCED A SKIN TEAR POST REMOVAL OF THE 3M¿ RED DOT¿ RESTING EKG ELECTRODE, 2360 LOT 2023-10 NM. THE 3M¿ RED DOT¿ RESTING EKG ELECTRODE REPORTEDLY CONTAINED "AN EXCESSIVE AMOUNT OF ADHESIVE." NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Skin Tears
MAUDE report 16864287 ↗InjuryApr 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED APPROXIMATELY EIGHT 2360 3M¿ RED DOT¿ EKG RESTING ELECTRODES WERE APPLIED TO HER LEGS, ARMS, COLLAR BONE AND UNDER HER BREAST FOR LESS THAN 5 MINUTES DURING AN EKG TEST. LATER THE SAME DAY, THE CONSUMER REPORTEDLY EXPERIENCED RED RAISED BUMPS, ITCHING AND WELTS WHERE EACH ELECTRODE HAD BEEN APPLIED. THE FOLLOWING DAY, ITCHING, HIVES, REDNESS AND A RASH SPREAD OUTWARD FROM EACH ELECTRODE SITE. THE CONSUMER WAS SEEN BY HER PRIMARY PHYSICIAN AND WAS TREATED WITH A STEROID INJECTION. THE CONSUMER REPORTED THE REACTION WAS IMPROVING.
Patient problems: Erythema; Itching Sensation; Rash
MAUDE report 8555879 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.