Medline MDSMIW616201Recalls & reported problems
Medline Industries, Inc. · ELECTRODE,ECG,TAB,10/CARD,4000/CS,INDIVI · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20888277699189), received between Sep 10, 2026 and Sep 29, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond2
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Loss of or Failure to Bond
It was reported that "The EKG tabs are not sticking to the patient even after trying to shave the area on patient to stick."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937016 ↗MalfunctionSep 10, 2026Loss of or Failure to Bond; Material Deformation
It was reported that electrodes are not sticking. Adhesive appears to be globbed onto the tab in some cases.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721470 ↗
Other Electrode, electrocardiograph devices
- Vermed A10091-30Graphic Controls Acquisition Corp · Electrode, Electrocardiograph132 reports
- 3M™ 22283m Company · Electrode, electrocardiograph2 recalls0 reports
- 3M™ Red Dot™ 22283m Company · Electrode, electrocardiograph1 recall4 reports
- Vital Signs™ 2464AAO-20AirLife Finland Oy · Electrode, electrocardiograph51 reports
- Vermed IP-Set M5 RT Adult-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
- Vermed IP-Set 5V RT Adult-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
- Vermed IP-Set 6V RT ADULT-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
- Vermed IP-Set 12 RT Adult-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page