Red Dot™ 2570Recalls & reported problems
3m Company · 3M™ Red Dot™ Monitoring Electrode with Foam Tape and Sticky Gel, 50/Bag, 20/Case, 72/Plt 2570 · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10707387463271), received between Feb 19, 2020 and Feb 1, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
- Patient-Device Incompatibility1
Patient problems
- Hypersensitivity/Allergic reaction1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 1, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
A 23-YEAR-OLD FEMALE ALLEGEDLY EXPERIENCED AN ANAPHYLACTIC REACTION WITH THE USE OF 3M¿ RED DOT¿ MONITORING ELECTRODE WITH FOAM TAPE AND STICKY GEL, 2570 THAT WAS SUBSEQUENTLY DESCRIBED AS A CHEST URTICARIAL SKIN REACTION. THE PATIENT'S SKIN WAS INITIALLY PREPPED WITH FASTAID® PRE-INJECTION SWAB (70% ISOPROPANOL), THREE ELECTRODES WERE APPLIED TO THE CHEST AREA THAT WERE HELD IN POSITION WITH AN O-FIX STICKER. THE FOLLOWING DAY, AN URTICARIAL SKIN REACTION WAS OBSERVED THAT WAS REPORTEDLY TREATED WITH ANTIHISTAMINES. UPON SUBSEQUENT REPRESENTATION, TONGUE SWELLING WAS IDENTIFIED. THE PATIENT WAS TREATED FOR ANGIOEDEMA WITH ANTIHISTAMINES, STEROIDS, INTRAMUSCULAR ADRENALINE AND WAS TRANSFERRED TO THE ICU [INTENSIVE CARE UNIT]. THE PATIENT REPORTEDLY HAD A "GOOD" RECOVERY. ON DAY THREE, THE PATIENT WAS TRANSFERRED TO THE WARD AND WAS SUBSEQUENTLY DISCHARGED HOME ON DAY FIVE.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 16279496 ↗MalfunctionFeb 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
A HOSPITAL EMPLOYEE REPORTED THAT 3M¿ RED DOT¿ MONITORING ELECTRODES WITH FOAM TAPE AND STICKY GEL, MODEL 2570, ARE GETTING STUCK IN THE LEAD WIRES, WHERE THE ELECTRODE BUTTONS CAME OFF THE ELECTRODE PAD AND STAYED LODGED IN THE LEAD SNAP. A NON-3M BRAND OF ECG LEAD WIRES WAS USED BY THE FACILITY. NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9727401 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.