CyberWand USL Advanced Transducer CW-USLTA (UDI H891CWUSLTA2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H891CWUSLTA2), received between Nov 23, 2021 and May 6, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2022Fire; Fire

  IT WAS REPORTED THAT WHEN THE CW-USLTA WAS ACTIVATED WITH THE CYBERWAND GENERATOR, THE CABLE CAUGHT FIRE AND FLAMES SHOT OUT OF THE END OF THE HANDPIECE. CUSTOMER SITE FACILITY BIOMED CONFIRMED THAT THE HANDPIECE WAS NOT IN THE PATIENT AT THE TIME OF THE INCIDENT, THE USER HAD THE HANDPIECE IN HIS HAND TESTING THE HANDPIECE. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THE INTENDED PROCEDURE ACCORDING TO THE CUSTOMER COMPLETED WITH ANOTHER DEVICE. CUSTOMER SITE BIOMED CONFIRMED THAT THE FIRE REPORTED TO HAVE COME FROM THE TRANSDUCER TIP. IT WAS NOT FROM THE GENERATOR AND THERE WAS NO PATIENT INJURY. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS REPORT IS RELATED TO A REPORT WITH PATIENT IDENTIFIER (B)(6) (GENERATOR).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14312262 ↗
• MalfunctionNov 23, 2021No Device Output; Failure to Power Up; No Device Output; Failure to Power Up

  AS REPORTED, DURING PREPARATION FOR USE, THE DEVICE WOULD NOT WORK. CUSTOMER STATED THAT THEY DID THE TUNING, SHUT DOWN THE DEVICE AND TURNED IT ON AND WOULD NOT WORK. CUSTOMER USED ANOTHER TRANSDUCER AND HAD NO ISSUES. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS REPORTED EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12862842 ↗