Valleylab E3530-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521767904), received between Apr 21, 2022 and Apr 21, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Melted” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2022Melted; Overheating of Device; Melted; Overheating of Device

  ACCORDING TO THE REPORTER, DURING  PNEUMONECTOMY WITH HEATED CHEMOTHERAPY, THE DEVICE OVERHEATED AND MELTED DURING THE PROCEDURE AND BURNT THE PATIENT. THE PATIENT HAD SEVERAL SMALL BURNS ON THE CHEST.

  Patient problems: Burn(s)

  MAUDE report 14165056 ↗