CUSA® Excel C3600Recalls & reported problems
Integra Lifesciences (Ireland) Limited · CUSA® Excel 23kHz CUSA® Manifold Tubing Set · Class U
All models of CUSA Excel (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780025856), received between Dec 12, 2025 and May 8, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
- Material Perforation1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2026Fluid/Blood Leak; Material Perforation
DURING THE PRE-USE TEST OF THE HANDPIECE, A WATER LEAK AND CUT WAS OBSERVED AT THE IRRIGATION TUBING OF THE CUSA EXCEL 23KHZ TUBING SET. THE TUBING WAS THEN REPLACED. NO INJURY OR SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25126106 ↗MalfunctionDec 12, 2025Material Puncture/Hole; Material Puncture/Hole
Other Device, neurosurgical fragmentation and aspiration devices
- CUSA® Excel C2600Integra Lifesciences (Ireland) Limited · Device, neurosurgical fragmentation and aspiration1 recall44 reports
- CUSA® Excel C3601Integra Lifesciences (Ireland) Limited · Device, neurosurgical fragmentation and aspiration7 reports
- CUSA® Excel C2601Integra Lifesciences (Ireland) Limited · Device, neurosurgical fragmentation and aspiration3 reports
- CUSA® Excel CUSAEXCEL2Integra Lifesciences (Ireland) Limited · Device, neurosurgical fragmentation and aspiration2 reports
- CUSA® Clarity C7420SIntegra Lifesciences (Ireland) Limited · Device, neurosurgical fragmentation and aspiration1 report
- CUSA® Clarity C7401SIntegra Lifesciences (Ireland) Limited · Device, neurosurgical fragmentation and aspiration1 report
- CUSA® Excel C4617SIntegra Lifesciences (Ireland) Limited · Device, neurosurgical fragmentation and aspiration1 report
- CUSA® Clarity C7523Integra Lifesciences (Ireland) Limited · Device, neurosurgical fragmentation and aspiration1 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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