CUSA® Excel CUSAEXCEL2Recalls & reported problems
Integra Lifesciences (Ireland) Limited · CUSA® Excel + Ultrasonic Tissue Ablation System · 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 10381780039259), received between Apr 16, 2025 and Aug 6, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Inability to Irrigate” (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
- Inability to Irrigate1
- Output below Specifications1
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.
MalfunctionAug 6, 2026Inability to Irrigate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50161277 ↗MalfunctionApr 16, 2025Output below Specifications; Output below Specifications
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 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.
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