CyberWand USL Foot Switch CW-USLFSRecalls & 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 00855279005306), received between Feb 23, 2021 and Feb 23, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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
- Loose or Intermittent Connection1
- 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.
MalfunctionFeb 23, 2021Loose or Intermittent Connection; Output Problem; Loose or Intermittent Connection; Output Problem
IT WAS REPORTED THAT THE DEVICE DISPLAYED ¿FAULT¿ ERROR MESSAGE. THE PORT THAT GOES TO THE FOOT PEDAL IS LOOSE. THERE WERE NO OTHER ISSUES NOTED ON THE DEVICE .THE ISSUE OCCURRED DURING SET UP. THE INTENDED PROCEDURE WAS ABLE TO BE COMPLETED WITH ANOTHER UNIT. THE SERIAL NUMBER AND MODEL OF THE DEVICE USED WERE NOT PROVIDED. THERE WAS NO PATIENT INVOLVEMENT ON THE REPORTED EVENT. NO USER INJURY REPORTED.
Patient problems: No Patient Involvement
MAUDE report 11366891 ↗
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 NoseCone Kit CW-USLNCCybersonics Inc · Lithotriptor, Electro-Hydraulic1 report
- CyberWand USL Advanced Transducer CW-USLTACybersonics Inc · 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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