HYFRECATOR 2000 7-900-115 (UDI 10653405031598)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653405031598), received between Oct 16, 2025 and Oct 16, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryOct 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE DEVICE, 7-900-115, HYFRECATOR 2000, 115V/50-60HZ, WAS BEING USED DURING LIPOMA EXCISION PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿DURING THE PROCEDURE, DR. JING USED OUR HYFRECATOR WHICH CAUSED TWO BURN MARKS ON THE PATIENTS LEFT LEG. A PT WAS INJURED TODAY DURING A LIPOMA EXCISION OF HIS RIGHT TEMPORAL. THIS DEVICE HAS BEEN USED SEVERAL TIMES BY MULTIPLE PROVIDERS AND IS UPDATE WITH INSPECTION. IT IS KEPT SECURELY IN A DRY LOCATION. I AM NOT SURE WHAT COULD BE THE REASON FOR THE MALFUNCTION.". FURTHER ASSESSMENT WAS REQUESTED FROM THE REPORTER, AND THEY STATED THAT NO FURTHER INFORMATION WAS AVAILABLE. THE TYPE OF MALFUNCTION OR RELATIONSHIP BETWEEN THE DEVICE AND HOW THE BURN WAS CAUSED IS NOT KNOWN AT THIS TIME. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY UNKNOWN DEGREE OF BURN TO PATIENT.

  Patient problems: Burn(s)

  MAUDE report 23308901 ↗