Visualase 9735560 (UDI 00763000540111)Recalls & reported problems
Medtronic Navigation, Inc. · VCLAS 9735560 10MM TIP/1.65MM CATHETER · Class 2
All models of Visualase (25)
Data updated Oct 16, 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 00763000540111), received between Sep 30, 2026 and Sep 30, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash1
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.
MalfunctionSep 30, 2026Leak/Splash
Medtronic received information regarding a thermal therapy system being used in a Hemispherectomy procedure. It was reported that the catheter started to leak. There was a two and a half hour delay due to troubleshooting and replacing the catheter. There was no impact on the patient's outcome.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948622 ↗
Other Neurosurgical laser with MR thermography devices
- Visualase 9735560Medtronic Navigation, Inc. · Neurosurgical laser with MR thermography1 recall59 reports
- Visualase 9735560Medtronic Navigation, Inc. · Neurosurgical laser with MR thermography1 recall4 reports
- Visualase 9735559Medtronic Navigation, Inc. · Neurosurgical laser with MR thermography1 recall3 reports
- Visualase 9735560Medtronic Navigation, Inc. · Neurosurgical laser with MR thermography1 recall3 reports
- Visualase 9735559Medtronic Navigation, Inc. · Neurosurgical laser with MR thermography1 recall0 reports
- Visualase 9735560Medtronic Navigation, Inc. · Neurosurgical laser with MR thermography44 reports
- Visualase 9735559Medtronic Navigation, Inc. · Neurosurgical laser with MR thermography15 reports
- Visualase 9735542Medtronic Navigation, Inc. · Neurosurgical laser with MR thermography15 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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