Medline MDSM616101Recalls & reported problems
Medline Industries, Inc. · ELECTRODE,ECG,TAB,10/CARD,5000/CS, SMALL · Class 2
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 80888277352321), received between Sep 15, 2026 and Sep 30, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (5 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.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond5
- Adhesive Too Strong1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Loss of or Failure to Bond
It was reported that "the electrodes came out defective, they adhesive is not working as it should. There is missing adhesive on the length of the tab."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946454 ↗MalfunctionSep 22, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860519 ↗MalfunctionSep 22, 2026Loss of or Failure to Bond
It was reported that the pads do not stick properly.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857008 ↗MalfunctionSep 21, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847043 ↗MalfunctionSep 21, 2026Loss of or Failure to Bond
It was reported that when the plastic is removed the adhesive is sticking to the plastic instead of to the electrode.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840767 ↗MalfunctionSep 15, 2026Adhesive Too Strong
It was reported that "Once we place on patient and try to take off, it leaves a sticky residue."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50772370 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.