Medline MDSM611950Recalls & reported problems
Medline Industries, Inc. · ELECTRODE,ECG,STRESS,FOAM,50PK · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20884389830465), received between Jun 12, 2024 and Sep 26, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Adhesive Too Strong” (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.
Reports received per month
Most reported problems
Device problems
- Adhesive Too Strong1
- Appropriate Device Problem Term/Code Not Available1
- High Readings1
- Loss of or Failure to Bond1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Rash1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2026Adhesive Too Strong
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906334 ↗MalfunctionSep 21, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50845181 ↗MalfunctionSep 14, 2026High Readings
It was reported that the issue was "inaccurate readings and spikes."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761421 ↗InjuryJun 12, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY ON 05/14/24 THE PATIENT EXPERIENCED AN "INTENSELY PRURITIC VESICULAR RASH WHERE MEDLINE ECG ELECTRODE WERE PLACED".
Patient problems: Rash
MAUDE report 19519440 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.