Medline MDSM611903Recalls & reported problems
Medline Industries, Inc. · ELECTRODE,ECG,STRESS,FOAM,3PK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884389830444), received between Jun 9, 2026 and Jun 9, 2026 — classified as 1 injury.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- High Blood Pressure/ Hypertension1
- Hypersensitivity/Allergic reaction1
- Tachycardia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 9, 2026Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER, SHE HAD AN EXTREME REACTION TO ELECTRODES THAT WERE USED ON HER. ACCORDING TO THE CUSTOMER, THE "AREAS WERE RED AND ITCHY ONCE ELECTRODES WERE REMOVED."
Patient problems: High Blood Pressure/ Hypertension; Hypersensitivity/Allergic reaction; Tachycardia
MAUDE report 25449298 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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