Level 1 H-31-ENRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 50695085829261), received between Jul 17, 2024 and Dec 3, 2024 — classified as 2 malfunctions.

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

• MalfunctionDec 3, 2024Device Emits Odor; Overheating of Device; Device Emits Odor; Overheating of Device

  IT WAS REPORTED THAT THE WAS A PRESSURE ISSUE AND THE DEVICE SMELLED LIKE IT WAS BURNING. THE EVENT OCCURRED DURING TESTING. THERE WAS NO PHYSICAL DAMAGE. THE DEVICE WAS NOT DROPPED. THERE WAS NO DELAY OF THERAPY. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20832393 ↗
• MalfunctionJul 17, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE WARMING SETS WERE DEFECTIVE. THE ISSUE DELAYED THERAPY TO THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19763006 ↗