CUSA® Excel C2600Recalls & reported problems
Integra Lifesciences (Ireland) Limited · CUSA® Excel 23KHz Straight Handpiece · Class U
All models of CUSA Excel (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Integra CUSA Excel straight handpiece is a surgical instrument that fragments and aspirates tissue during neurosurgery. The 44 reports mostly describe the housing cracking, the handpiece overheating during surgery, and units not working right after assembly, with irrigation and suction blockage and vibration output sometimes failing, which in several cases delayed operations. There are no deaths and no injuries. One open recall, started in May 2024, covers the potential for the housing to crack and delay treatment.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 44
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10381780039419), received between May 10, 2021 and Apr 17, 2026 — classified as 44 malfunctions.
The most frequently reported specific device problem is “Crack” (12 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- May 29, 2024Open, Classified
Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment
Z-2167-2024 · Root cause: Process design · Recall details · FDA record ↗
Most reported problems
Device problems
- Crack12
- Overheating of Device10
- Misassembled During Installation7
- Output Problem4
- Failure to Deliver Energy3
- Fracture3
- Inability to Irrigate3
- Incorrect, Inadequate or Imprecise Result or Readings3
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- Insufficient Information3
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2026Inability to Irrigate
A FACILITY REPORTED THAT DURING SURGERY, THE CUSA EXCEL 23KHZ STRAIGHT HANDPIECE (C2600) HAD AN IRRIGATION ISSUE AND ALARMED. THERE WAS SURGICAL DELAY OF MORE THAN 30 MINUTES; HOWEVER, THERE WAS NO PATIENT INJURY. THE SURGERY WAS COMPLETED WITH ANOTHER HANDPIECE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24911569 ↗MalfunctionMar 9, 2026Output below Specifications
A FACILITY REPORTED THAT THE NOSECONE OF THE CUSA EXCEL 23KHZ STRAIGHT HANDPIECE (C2600) WAS NOT WORKING AND FOUND TO BE NON-FUNCTIONAL DURING SURGERY. THE NOSECONE WAS NOT TRANSMITTING VIBRATION, RESULTING IN NO COAGULATION. THERE WAS A 2-HOUR SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24552691 ↗MalfunctionFeb 13, 2026Overheating of Device; Suction Problem
A FACILITY REPORTED THAT THE CUSA EXCEL 23KHZ STRAIGHT HANDPIECE (C2600) WAS GETTING HOT DURING SURGERY AND THE SUCTION WAS NOT PROPER. ADDITIONALLY, BLOCKAGE OF THE HANDPIECE OCCURRED MULTIPLE TIMES ALONG WITH HEATING ISSUES WHICH RESULTED IN SURGICAL DELAY OF APPROXIMATELY 80 MINUTES. THERE WAS NO PATIENT OR USER INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24333872 ↗MalfunctionFeb 12, 2026Crack; Overheating of Device
A FACILITY REPORTED THAT A LOANER CUSA EXCEL 23KHZ STRAIGHT HANDPIECE (C2600) IS CRACKED AND OVERHEATING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24329067 ↗MalfunctionDec 30, 2025Overheating of Device; Overheating of Device
MalfunctionDec 29, 2025Failure to Deliver Energy; Misassembled During Installation; Failure to Deliver Energy; Misassembled During Installation
THIS IS 2 OF 2 REPORTS WE RECEIVED INVOLVING THE SAME CUSA HANDPIECE - REFER TO MFG REPORT NUMBER 3006697299-2025-00140. AN AUTHORIZED DISTRIBUTOR REPORTED THAT DURING SURGERIES, THE CUSA EXCEL 23KHZ STRAIGHT HANDPIECE (C2600) SEEMED TO BE HAVING MISALIGNMENT ISSUED DUE TO WHICH THE SUCTION TUBING COULD NOT BE CONNECTED PROPERLY. THE USER COMMENTED THAT THE HANDPIECE IS WORKING; HOWEVER, IT CAUSES "COOLING WATER ERROR" INTERMITTENTLY AND STOPS THE SESSION. THE HANDPIECE STOPPED AFTER 5 MIN OF WORKING. DUE TO THE HANDPIECE BEING OUT OF ORDER, THEY USED OTHER TECHNIQUES WHICH LED TO INCREASED SURGICAL TIME OF 3-4 HOURS. THE PROCEDURE WAS COMPLETED BY USING "LIGASURE DEVICE AND MONOPOLAR LAPAROSCOPIC¿. THERE WERE NO PATIENT INJURIES. NAME OF HOSPITAL AND COUNTRY: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23917247 ↗MalfunctionDec 29, 2025Failure to Deliver Energy; Misassembled During Installation; Failure to Deliver Energy; Misassembled During Installation
THIS IS 1 OF 2 REPORTS WE RECEIVED INVOLVING THE SAME CUSA HANDPIECE - REFER TO MFG REPORT NUMBER 3006697299-2025-00141. AN AUTHORIZED DISTRIBUTOR REPORTED THAT DURING SURGERIES, THE CUSA EXCEL 23KHZ STRAIGHT HANDPIECE (C2600) SEEMED TO BE HAVING MISALIGNMENT ISSUED DUE TO WHICH THE SUCTION TUBING COULD NOT BE CONNECTED PROPERLY. THE USER COMMENTED THAT THE HANDPIECE IS WORKING; HOWEVER, IT CAUSES "COOLING WATER ERROR" INTERMITTENTLY AND STOPS THE SESSION. THE HANDPIECE STOPPED AFTER 5 MIN OF WORKING. DUE TO THE HANDPIECE BEING OUT OF ORDER, THEY USED OTHER TECHNIQUES WHICH LED TO INCREASED SURGICAL TIME OF 3-4 HOURS. THE PROCEDURE WAS COMPLETED BY USING "LIGASURE DEVICE AND MONOPOLAR LAPAROSCOPIC¿. THERE WERE NO PATIENT INJURIES. NAME OF HOSPITAL AND COUNTRY: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23917206 ↗MalfunctionNov 17, 2025Overheating of Device; Overheating of Device
MalfunctionNov 10, 2025Overheating of Device; Overheating of Device
MalfunctionAug 14, 2025Crack; Crack
MalfunctionJun 11, 2025Crack; Inability to Irrigate; Overheating of Device; Crack; Inability to Irrigate; Overheating of Device
A FACILITY REPORTED THAT THE CUSA EXCEL 23KHZ STRAIGHT HANDPIECE (C2600) WAS CRACKED, EMITTED A COOLING WATER ALARM AND HEATED DURING OPERATION. THERE WAS SURGICAL DELAY OF LESS THAN 30 MINUTES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22185325 ↗MalfunctionJun 11, 2025Energy Output Problem; Energy Output Problem
MalfunctionMar 13, 2025Overheating of Device; Overheating of Device
A FACILITY REPORTED THAT HEAT BUILDS UP ON THE EXCEL 23KHZ STRAIGHT HANDPIECE (C2600). THERE WAS NO PATIENT/USER INJURY OR SIGNIFICANT SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21602010 ↗MalfunctionFeb 21, 2025Crack; Crack
A FACILITY REPORTED THAT THE CUSA EXCEL 23KHZ STRAIGHT HANDPIECE WAS NOTED TO HAVE CRACKED HOUSING WHEN SETTING UP THE DEVICE FOR A PROCEDURE. THE PATIENT WAS ALREADY UNDER ANESTHESIA, AND THERE WAS APPROXIMATELY 30 MINUTES DELAY. ANOTHER HANDPIECE WAS USED FOR THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21433406 ↗MalfunctionJan 3, 2025Crack; Crack
MalfunctionDec 27, 2024Crack; Misassembled During Installation; Crack; Misassembled During Installation
A FACILITY REPORTED THAT THE CUSA EXCEL 23KHZ STRAIGHT HANDPIECE (C2600) HAD A CRACKED CASE AND WAS OVERTORQUED DURING AN UNSPECIFIED SURGERY. THERE WAS A DELAY OF APPROXIMATELY 30 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21027082 ↗MalfunctionDec 4, 2024Misassembled During Installation; Misassembled During Installation
A FACILITY REPORTED THAT DURING AN OPERATION IN WHICH THE CUSA EXCEL 23KHZ STRAIGHT HANDPIECE (C2600) AND THE "CUSA EXCEL W/ CONSOLE 220V AC WITH FOOTSWITCH WAS USED, THE MONITOR WENT TO FLUSH ALARM. THIS ISSUE EXTENDED THE SURGERY TIME FOR APPROXIMATELY 30 MINUTES, AND THE SURGERY WAS COMPLETED WITH A SECOND REPLACEMENT DEVICE. ACCORDING TO THE TECHNICAL SERVICE TEAM, THEY DID NOT CHECK THE CONSOLE WITH ANOTHER HANDPIECE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20849304 ↗MalfunctionOct 21, 2024Failure to Power Up; Failure to Power Up
THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3006697299-2024-00158: A FACILITY REPORTED THAT DURING A LAPAROSCOPIC CASE, THE CUSA EXCEL 23KHZ STRAIGHT HANDPIECE (C2600) EXPERIENCED A FAULT AND THEY HAD TO REVERT TO AN OPEN PROCEDURE. THE DEVICE PRIMED AS NORMAL AND NO ISSUE WAS EVIDENT, HOWEVER THE SURGEON WAS UNABLE TO ACTIVATE THE HANDPIECE ON USE. ADDITIONAL INFORMATION SUBSEQUENTLY RECEIVED: DID THE ISSUE HAPPEN BEFORE THE SURGERY OR DURING THE SURGERY? THERE WERE TWO ISSUES WITH TWO DIFFERENT HAND PIECES. THE ISSUE WAS WITH THE CONSOLE NOT PASSING ITS STARTUP, THE ALARM STATE AFTER TURNING ON IT DISPLAYED AN IRRIGATION ALARM, SO WE CHECKED THE RESERVOIR, CHECK TUBING AND CONNECTION AND RESEATED HAND PIECE TO NO RESOLVE (THIS WAS BEFORE THE SURGERY). THE THEATRE TEAM THEN GOT A SECONDHAND PIECE THIS TIME THE STARTUP, HEADPIECE TEST AND PRIME ALL WORKED. SURGEON THEN WENT TO USE THE INSTRUMENT AND REPORTED IT AS NOT WORKING DURING THE SURGERY. WAS THE SURGERY TIME INCREASED? IF YES, HOW MANY TIMES APPROXIMATIVELY (= OR > 30 MINUTES)? THEATRE TEAM WOULD NEED TO ADD COMMENT FOR ACTUAL TIMING OF THE DELAY, BUT I WOULD SAY BELOW 30MINS. WAS THE PATIENT INJURED? NO PATIENT INJU
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20498395 ↗MalfunctionOct 21, 2024Failure to Power Up; Failure to Power Up
MalfunctionSep 24, 2024Failure to Deliver Energy; Failure to Deliver Energy
A FACILITY REPORTED THAT THE CUSA EXCEL 23KHZ STRAIGHT HANDPIECE (C2600) DEVELOPED A FAULT MID CASE, RESULTING IN CONVERSION TO OPEN PROCEDURE AND SWAP TO THE CUSA CLARITY. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT: "SURGERY TIME WAS INCREASED BY APPROXIMATELY 1 HOUR + DUE TO THE FOLLOWING: TROUBLESHOOTING OF THE MACHINE BY THE TEAM, RESTARTING THE UNIT, REPRIMING THE UNIT, CONVERTING FROM A LAPAROSCOPIC TO OPEN PROCEDURE, SETTING UP THE CUSA CLARITY UNIT, OPENING MORE INSTRUMENT TRAYS TO CARRY OUT THE OPEN PROCEDURE. THEREFORE: PATIENT REQUIRED AN OPEN PROCEDURE, MEANING A SIGNIFICANTLY LARGER WOUND TO BE CARED FOR, A LONGER STAY IN HOSPITAL, A LONGER POST OPERATIVE RECOVERY TIME OVERALL. SURGERY WAS FINISHED USING THE CUSA CLARITY UNIT WE HAVE IN THE DEPARTMENT PATIENT WAS AN ADULT SURGERY WAS A LIVER RESECTION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20293425 ↗MalfunctionSep 24, 2024Misassembled During Installation; Misassembled During Installation
A FACILITY REPORTED THAT THE CUSA EXCEL 23KHZ STRAIGHT HANDPIECE (C2600) CANNOT BE CONNECTED AS THE TIP WAS TWISTED (OVERTORQUED). ADDITIONAL INFORMATION WAS SUBSEQUENTLY RECEIVED INDICATING THE FOLLOWING: THE INTERNAL COOLING WATER SYSTEM OF A CONCOMITANT DEVICE USED (CUSAEXCEL9) PROBABLY HAS A LEAK, WHICH LED TO WATER ESCAPING AT THE POINT OF CONTACT WITH THE HANDPIECE CABLE. THE DEFECT WAS DETECTED INTRAOPERATIVELY BEFORE THE HANDPIECE WAS USED. THE SURGERY THEN HAD TO BE CONTINUED WITH ULTRACISION, AND THE SURGICAL TIME WAS GREATLY EXTENDED AS A RESULT. NO ADVERSE PATIENT IMPACT HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20291608 ↗MalfunctionAug 22, 2024Fracture; Misassembled During Installation; Fracture; Misassembled During Installation
THIS IS 1 OF 2 REPORTS FOR THE 2ST HANDPIECE, AND LINKED TO MFG REPORT NUMBER 3006697299-2024-00122: A FACILITY REPORTED THAT THE FIRST CUSA EXCEL 23KHZ STRAIGHT HANDPIECE (C2600) DID NOT WORK SO THEY WANTED TO USE THE SECOND CUSA HANDPIECE WHICH DID NOT WORK ALSO AS IT WAS MISALIGNED. THEY MANAGED TO REALIGN IT AND USE IT FOR THE SURGERY. THE ISSUE WAS DETECTED BEFORE SURGERY; HOWEVER, THERE WAS NO INJURY. ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: ¿ DID THE PROBLEM APPEAR BEFORE AN OPERATION (PATIENT PREPARED/UNDER ANESTHESIA)? >> YES. ¿ DID THE PROBLEM LEAD TO AN INCREASE IN THE DURATION OF THE PROCEDURE (= OR > 30 MINUTES)? >> 30 MINUTES. ¿ DID THIS INCIDENT HAVE ANY CONSEQUENCES FOR THE PATIENT? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20027948 ↗MalfunctionAug 21, 2024Misassembled During Installation; Misassembled During Installation
THIS IS 2 OF 2 REPORTS FOR THE 2ND HANDPIECE, AND LINKED TO MFG REPORT NUMBER 3006697299-2024-00121: A FACILITY REPORTED THAT THE FIRST CUSA EXCEL 23KHZ STRAIGHT HANDPIECE (C2600) DID NOT WORK SO THEY WANTED TO USE THE SECOND CUSA HANDPIECE WHICH DID NOT WORK ALSO AS IT WAS MISALIGNED. THEY MANAGED TO REALIGN IT AND USE IT FOR THE SURGERY. THE ISSUE WAS DETECTED BEFORE SURGERY; HOWEVER, THERE WAS NO INJURY. ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: DID THE PROBLEM APPEAR BEFORE AN OPERATION (PATIENT PREPARED/UNDER ANESTHESIA)? YES. DID THE PROBLEM LEAD TO AN INCREASE IN THE DURATION OF THE PROCEDURE (= OR > 30 MINUTES)? 30 MINUTES. DID THIS INCIDENT HAVE ANY CONSEQUENCES FOR THE PATIENT? NO. THE SECOND HP WORK. THEY DETECTED THE DISCREPANCY BETWEEN IRRIGATION TUBE AND THE PART THAT PERMIT INSERTION OF THE TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20012756 ↗MalfunctionJul 8, 2024Overheating of Device; Overheating of Device
A DISTRIBUTOR HAS REPORTED THAT THE CUSA EXCEL 23KHZ STRAIGHT HANDPIECE (C2600) IS OVERHEATING. NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19697579 ↗MalfunctionMay 9, 2024Vibration; Vibration
AN AUTHORIZED DISTRIBUTOR REPORTED THAT THE CUSA EXCEL 23KHZ STRAIGHT HANDPIECE (C2600) EMITTED A VIBRATION ALERT DURING A CASE. THERE WAS NO IMPACT TO THE PATIENT, BUT INCREASED SURGERY TIME OF LONGER THAN 30 MINUTES WAS REPORTED. FINAL USER: (B)(6) HOSPITAL .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19279376 ↗
Other Device, neurosurgical fragmentation and aspiration devices
- 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® 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 · each recall links to the FDA recall notice
- 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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