Valleylab E7508Recalls & reported problems
Covidien LP · REM Polyhesive (TM) Adult Cordless Patient Return Electrode · Class 2
All models of Valleylab (97)
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 10884524000992), received between Nov 2, 2018 and Nov 28, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (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. 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
- Adverse Event Without Identified Device or Use Problem2
- Difficult to Remove1
Patient problems
- Burn(s)1
- Partial thickness (Second Degree) Burn1
- Skin Discoloration1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 28, 2025Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING THE PROCEDURE, THE ADHESIVE OF THE RETURN ELECTRODE WAS NOT EASILY REMOVED. THE PATIENT HAD BURN AND A REDDENED MARK REMAINED AROUND THE ENTIRE CONTOUR OF THE PLAQUE.
Patient problems: Burn(s); Skin Discoloration
MAUDE report 23669821 ↗MalfunctionNov 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE PATIENT'S ATTORNEY, DURING A RADIO ABLATION PROCEDURE, THE PATIENT SUFFERED SIGNIFICANT SECOND DEGREE BURNS AND EMOTIONAL INJURIES, INCLUDING THE NEED FOR FURTHER WOUND CARE FROM THE RETURN ELECTRODE PAD THAT WAS USED.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 8034758 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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