CUSA® Excel C2601Recalls & reported problems
Integra Lifesciences (Ireland) Limited · CUSA® Excel CUSA® Excel 23kKHz Angled Handpiece · Class U
All models of CUSA Excel (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780039426), received between Jan 2, 2024 and May 14, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Energy 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Energy Output Problem1
- Fracture1
- Overheating of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Burn(s)1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2025Overheating of Device; Overheating of Device
MalfunctionMar 27, 2025Energy Output Problem; Energy Output Problem
A FACILITY REPORTED THAT PRIOR TO AN UNSPECIFIED SURGERY, THE CUSA EXCEL 23KHZ ANGLED HANDPIECE (C2601) WAS DEFECTIVE. THE EXACT DEVICE MALFUNCTION IS NOT KNOWN, BUT THE PATIENT WAS PREPARED/UNDER ANESTHESIA AT THE TIME, THERE WAS INCREASED SURGICAL TIME AS A RESULT. THE HANDPIECE WAS USED WITH AN OLD CONSOLE CUSA EXCEL8, WHICH IS NOT REPAIRABLE. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: "THE SURGEON DOES NOT WANT TO ANSWER THE QUESTIONS "YOUR SALES REP INFORMS ME THAT NO REPAIR IS POSSIBLE ON OUR DEVICE BECAUSE YOU HAVE DECLARED IT OBSOLETE. YOUR QUESTIONS ARE THEREFORE IRRELEVANT." THE SURGEON DOES NOT WANT TO ANSWER THE QUESTIONS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21708694 ↗MalfunctionJan 2, 2024Fracture; Fracture
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 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® 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.
How reports and recalls are matched · Editorial policy · Report an error on this page