HYFRECATOR 2000 7-900-115 (UDI 20653405031595)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20653405031595), received between Oct 17, 2023 and Oct 17, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended Electrical Shock” (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 18, 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.

• MalfunctionOct 17, 2023Unintended Electrical Shock; Unintended Electrical Shock

  THE CUSTOMER REPORTED THAT THE 7-900-115, HYFRECATOR 2000, 115V DEVICE WAS BEING USED DURING A REMOVAL OF A SKIN LESION PROCEDURE ON (B)(6)23 WHEN IT WAS REPORTED ¿HYFRECATOR THAT IS SHOCKING MY PHYSICIAN WHEN SHE USES IT. IT WAS CONFIRMED THAT THE PATIENT/USER WAS NOT DIAGNOSED WITH A BURN AND ¿USER RECEIVED SMALL SHOCK¿. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THE CURRENT STATUS OF THE PATIENT/USER WAS REPORTED AS ¿FINE¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: Electric Shock

  MAUDE report 17950877 ↗