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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

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