Valleylab E1504Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884524001333), received between Jan 21, 2022 and Oct 5, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Peeled/Delaminated” (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.

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.

• MalfunctionOct 5, 2023Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPY WITH BIOPSY OF THE PERITONEUM, BOVIE EXTENDER BURNED THE PERITONEUM WHILE LYING ACROSS IT, INDICATING FAULTY INSULATION. THE PRODUCT HAD BEEN THROUGH STERILE PROCESSING PRIOR TO USE. THE PATIENT HAD SUPERFICIAL (FIRST DEGREE) BURN. THERE WAS NO TREATMENT DONE FOR THE BURN SITE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 17876685 ↗
• InjuryJan 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN ATRAUMATIC CORONARY ARTERY BYPASS, THE LIGASURE COULD NOT ACTIVATE AS THERE WAS AN ERROR MESSAGE. THE PROCEDURE WAS THEN CONTINUED WITH AN ELECTRODE TOGETHER WITH A COMPETITOR'S PENCIL AND A GENERATOR WHERE IT WAS REPORTED THAT THE COMPETITOR'S PENCIL AND THE GENERATOR WORKED WITHOUT BEING ACTIVATED AND THAT THE PENCIL WAS WARM. AN ELECTRO SURGICAL CUT WITH NO BURNT EDGES WAS VISIBLE ON THE AORTA THAT CAUSED 1 LITER OF BLOOD LOSS AND HAD TO BE CLOSED VIA SUTURING.

  Patient problems: Full thickness (Third Degree) Burn; Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 13314391 ↗