CyberWand USL Advanced Transducer CW-USLTA (UDI 00855279005320)Recalls & reported problems
Cybersonics Inc · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00855279005320), received between Mar 16, 2021 and Mar 16, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Output Problem” (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
Device problems
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 16, 2021Output Problem; Output Problem
IT WAS REPORTED THAT THE DEVICE PROBE WAS NOT WORKING, WHEN TRY TO TUNE, THERE IS NO DISPLAY, JUST THREE (3) LITTLE LIGHTS. THE USER TRIED ANOTHER TRANSDUCER AND WAS NOTED TO BE WORKING. LOT NUMBER OF THE TRANSDUCER USED NOT PROVIDED. THE ISSUE OCCURRED DURING PREPARATION FOR USE. NO PATIENT INVOLVEMENT, NO USER INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11494711 ↗
Other Lithotriptor, Electro-Hydraulic devices
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- Autolith Touch M005466800Northgate Technologies Inc. · Lithotriptor, Electro-Hydraulic1 recall12 reports
- Ultrasound Probe M0068407170Boston Scientific Corporation · Lithotriptor, electro-hydraulic15 reports
- CyberWand USL Ultrasonic Lithotripsy System CW-USLSACybersonics Inc · Lithotriptor, Electro-Hydraulic4 reports
- Ultrasound Probe M0068407160Boston Scientific Corporation · Lithotriptor, electro-hydraulic3 reports
- CyberWand USL Advanced Transducer CW-USLTACybersonics Inc · Lithotriptor, Electro-Hydraulic2 reports
- CyberWand USL NoseCone Kit CW-USLNCCybersonics Inc · Lithotriptor, Electro-Hydraulic1 report
- StoneBreaker G52605Cook Incorporated · Lithotriptor, electro-hydraulic1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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