CyberWand USL NoseCone Kit CW-USLNCRecalls & 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 H891CWUSLNC2), received between Jan 27, 2021 and Jan 27, 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 Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2021Output Problem; Output Problem
UPDATES ON THE REPORTED EVENT: PROBLEM WAS FIRST NOTICED DURING SET UP OF A CASE. NO DELAY OF PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT DEVICE. NO INFORMATION AVAILABLE FOR THE DEVICE USED. CURRENTLY CUSTOMER HAS LOANER DEVICE. NO OTHER INFORMATION PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 11236467 ↗
Other Lithotriptor, Electro-Hydraulic devices
- Lithotripsy Probe 1.9FR 375cm DS M00546620Northgate Technologies Inc. · Lithotriptor, Electro-Hydraulic1 recall1 death19 reports
- 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 Advanced Transducer CW-USLTACybersonics 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.
How reports and recalls are matched · Editorial policy · Report an error on this page