CUSA ExcelRecalls & reported problems across all models
Integra Lifesciences (Ireland) Limited · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one CUSA Excel model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 116
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 1
We found 14 models of CUSA Excel by Integra Lifesciences (Ireland) Limited in the FDA's device registry (GUDID). Together they are named in 116 adverse event reports in the FDA's MAUDE database, received between May 10, 2021 and Aug 6, 2026 — classified as 7 injuries, 109 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (31 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
CUSA Excel recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 CUSA Excel problems
Device problems
- Overheating of Device31
- Crack14
- Incorrect, Inadequate or Imprecise Result or Readings10
- Output Problem9
- Energy Output Problem8
- Misassembled During Installation8
- Inability to Irrigate7
- Output below Specifications7
Patient problems
- No Clinical Signs, Symptoms or Conditions105
- Burn(s)4
- Insufficient Information4
- Hemorrhage/Blood Loss/Bleeding3
CUSA Excel models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CUSA® Excel C2600Device, neurosurgical fragmentation and aspiration1 recall44 reports
- CUSA® Excel C2602Instrument, ultrasonic surgical43 reports
- CUSA® Excel C3601Device, neurosurgical fragmentation and aspiration7 reports
- CUSA® Excel C4604ELTInstrument, ultrasonic surgical3 reports
- CUSA® Excel C4614SInstrument, ultrasonic surgical3 reports
- CUSA® Excel C6636Instrument, ultrasonic surgical3 reports
- CUSA® Excel C2601Device, neurosurgical fragmentation and aspiration3 reports
- CUSA® Excel C3600Device, neurosurgical fragmentation and aspiration2 reports
- CUSA® Excel C4613SInstrument, ultrasonic surgical2 reports
- CUSA® Excel CUSAEXCEL2Device, neurosurgical fragmentation and aspiration2 reports
- CUSA® Excel C4601SInstrument, ultrasonic surgical1 report
- CUSA® Excel C4608SInstrument, ultrasonic surgical1 report
- CUSA® Excel C4617SDevice, neurosurgical fragmentation and aspiration1 report
- CUSA® Excel C6623Instrument, ultrasonic surgical1 report
Recent CUSA Excel adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionJul 27, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50025488 ↗MalfunctionMay 15, 2026Fluid/Blood Leak
AN AUTHORIZED DISTRIBUTOR REPORTED THAT THE AIR WAS LEAKING INSIDE THE TUBING OF THE CUSA EXCEL 36KHZ TUBING SET (C3601) DURING A PROCEDURE. THE DEVICE WAS REPLACED AND NO SURGICAL DELAY RESULTED. NO PATIENT INJURY OCCURRED, AND THE PATIENT'S CURRENT STATUS IS REPORTED TO BE GOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25185785 ↗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 ↗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 ↗MalfunctionApr 10, 2026Accessory Incompatible
A FACILITY REPORTED THAT THEY ENCOUNTERED DIFFICULTY TO SCREW THE CUSA EXCEL 36KHZ STANDARDTIP STRAIGHT TIP (C4613S) INTO THE EXCEL 36KHZ HANDPIECE. THE USER TRIED THE 2ND SET OF C4613S TIP WITH THE SAME BATCH AND THE ISSUE STILL OCCURRED. ANOTHER BATCH OF C4613S TIP WAS SCREWED INTO THE SAME HANDPIECE, AND THE ISSUE WAS RESOLVED. THE SURGERY WAS DELAYED FOR APPROXIMATELY 30 MINUTES DUE TO PRODUCT DEFECT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24839735 ↗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 ↗MalfunctionFeb 6, 2026Energy Output Problem
AN AUTHORIZED DISTRIBUTOR REPORTED THAT THE CUSA EXCEL 36KHZ STRAIGHT HANDPIECE IS DEFECTIVE WHICH RESULTED IN INCREASED SURGICAL TIME OF 30 MINUTES OR MORE. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279050 ↗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 ↗MalfunctionDec 12, 2025Material Puncture/Hole; Material Puncture/Hole
MalfunctionNov 17, 2025Overheating of Device; Overheating of Device
Other Integra Lifesciences (Ireland) Limited products
All Integra Lifesciences (Ireland) Limited devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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