Valleylab E2515HDANSBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884524003610), received between Sep 6, 2018 and Sep 6, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Arcing” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2018Arcing; Arcing

  ACCORDING TO THE REPORTER, DURING MULTIPLE PROCEDURES, THE PENS WERE SPARKING AND FLAME ISSUES FROM WHERE THE PART CONNECTS THE METAL TIP WOULD CATCH ON A BIG FLAME.

  Patient problems: No Information

  MAUDE report 7850913 ↗
• MalfunctionSep 6, 2018Arcing; Arcing

  ACCORDING TO THE REPORTER, DURING MULTIPLE PROCEDURES, THE PENS WERE SPARKING AND FLAME ISSUES FROM WHERE THE PART CONNECTS THE METAL TIP WOULD CATCH ON A BIG FLAME.

  Patient problems: No Information

  MAUDE report 7850543 ↗