CUSA® Clarity C7401SRecalls & reported problems
Integra Lifesciences (Ireland) Limited · CUSA® Clarity Standard Tip · Class U
All models of CUSA Clarity (21)
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 10381780466147), received between Mar 18, 2025 and Mar 18, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Crack” (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
- Crack1
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 18, 2025Crack; Crack
A FACILITY REPORTED THAT WHEN USING THE CUSA CLARITY 23KHZ STANDARD TIP (C7401S), THE DOCTOR NOTICED THAT THE TIP WAS BROKEN. THERE WAS THE POSSIBILITY OF THE DEVICE REMAINING IN THE PATIENT¿S BODY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO INFORMATION ON SURGICAL DELAY HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21632088 ↗
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® Excel C3600Integra Lifesciences (Ireland) Limited · Device, neurosurgical fragmentation and aspiration2 reports
- CUSA® Clarity C7420SIntegra 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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