CUSA ClarityRecalls & reported problems across all models
Integra Lifesciences (Ireland) Limited · 21 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 Clarity model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 121
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls
- 1
We found 21 models of CUSA Clarity by Integra Lifesciences (Ireland) Limited in the FDA's device registry (GUDID). Together they are named in 121 adverse event reports in the FDA's MAUDE database, received between May 26, 2021 and Jul 27, 2026 — classified as 14 injuries, 107 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (27 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 Clarity 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.
- Mar 6, 2026Open, Classified
Software issue that renders the touch screen unresponsive.
Z-1828-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported CUSA Clarity problems
Device problems
- Overheating of Device27
- Crack17
- Intermittent Communication Failure9
- Erratic or Intermittent Display7
- Power Problem5
- Adverse Event Without Identified Device or Use Problem4
- Break4
- Device Handling Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions99
- Bacterial Infection4
- Insufficient Information4
- Superficial (First Degree) Burn3
- Burn(s)2
- Easy Bruising2
- Hemorrhage/Blood Loss/Bleeding2
- Rupture2
CUSA Clarity models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CUSA® Clarity C7000Instrument, ultrasonic surgical1 recall37 reports
- CUSA® Clarity C7036Instrument, ultrasonic surgical29 reports
- CUSA® Clarity C7023Instrument, ultrasonic surgical11 reports
- CUSA® Clarity C7415SInstrument, ultrasonic surgical10 reports
- CUSA® Clarity C7411SInstrument, ultrasonic surgical8 reports
- CUSA® Clarity C7300Instrument, ultrasonic surgical6 reports
- CUSA® Clarity C7417SInstrument, ultrasonic surgical3 reports
- CUSA® Clarity C7002Instrument, ultrasonic surgical2 reports
- CUSA® Clarity C7415SEAInstrument, ultrasonic surgical2 reports
- CUSA® Clarity C7418SInstrument, ultrasonic surgical2 reports
- CUSA® Clarity C7602EAInstrument, ultrasonic surgical1 report
- CUSA® Clarity C7411SEAInstrument, ultrasonic surgical1 report
- CUSA® Clarity C7401SDevice, neurosurgical fragmentation and aspiration1 report
- CUSA® Clarity C7420SDevice, neurosurgical fragmentation and aspiration1 report
- CUSA® Clarity C7523Device, neurosurgical fragmentation and aspiration1 report
- CUSA® Clarity C7601Instrument, ultrasonic surgical1 report
- CUSA® Clarity C7601EADevice, neurosurgical fragmentation and aspiration1 report
- CUSA® Clarity C7404SInstrument, ultrasonic surgical1 report
- CUSA® Clarity C7404LSInstrument, ultrasonic surgical1 report
- CUSA® Clarity C7421SInstrument, ultrasonic surgical1 report
- CUSA® Clarity C7523XInstrument, ultrasonic surgical1 report
Recent CUSA Clarity adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2026Crack
MalfunctionJul 27, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50025484 ↗MalfunctionMay 15, 2026Intermittent Communication Failure
A FACILITY REPORTED THAT WHEN STARTING UP THE C7000 CUSA CLARITY CONSOLE DURING SURGERY, SYSTEM ERROR OCCURRED. THE DEVICE WAS REBOOTED SEVERAL TIMES, BUT THE ERROR COULD NOT BE FIXED. THE PATIENT WAS UNDER ANESTHESIA AND THE ABDOMEN WAS OPEN. BY PERFORMING MEMORY REFRESH, THE SAME DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY; HOWEVER, THERE WAS 2 HOURS OF SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25185291 ↗MalfunctionMay 8, 2026Crack
THIS REPORT IS 1 OF 2 FOR THE FIRST PRODUCT REPORTED AND IS LINKED TO MFG REPORT NUMBER 3006697299-2026-00045: A FACILITY REPORTED THAT THE CUSA CLARITY 36KHZ CURVED EXTENDED MICROTIP¿ (C7415S) WAS USED IN AN ENDOSCOPIC INTRACRANIAL TUMOR RESECTION WITH CUSA CONSOLE C7000 AND CUSA HANDPIECE C7036. HOWEVER, AFTER 5 MINUTES OF USE THE DEVICE BROKE (SETTING OF THE DEVICE WHEN IT HAPPENED: AMPLITUDE 80, TISSUE SELECT 0, ASPIRATION 70, IRRIGATION 3). A SECOND PRODUCT WAS USED BUT ALSO BROKE AFTER 10 MINUTES OF USE. THE MAXILLARY SINUS AND ROOT OF THE TIP WERE TOUCHING AND THAT MAY HAVE PUT A STRAIN ON THE PRODUCT. A THIRD PRODUCT WAS USED TO COMPLETE THE SURGERY, AND A CT SCAN WAS TAKEN TO ENSURE THAT NO PARTS WERE LEFT IN THE PATIENT. THERE WAS NO SURGICAL DELAY OR INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25126124 ↗MalfunctionMay 8, 2026Crack
THIS REPORT IS 2 OF 2 FOR THE SECOND PRODUCT REPORTED AND IS LINKED TO MFG REPORT NUMBER 3006697299-2026-00044: A FACILITY REPORTED THAT THE CUSA CLARITY 36KHZ CURVED EXTENDED MICROTIP¿ (C7415S) WAS USED IN AN ENDOSCOPIC INTRACRANIAL TUMOR RESECTION WITH CUSA CONSOLE C7000 AND CUSA HANDPIECE C7036. HOWEVER, AFTER 5 MINUTES OF USE THE DEVICE BROKE (SETTING OF THE DEVICE WHEN IT HAPPENED: AMPLITUDE 80, TISSUE SELECT 0, ASPIRATION 70, IRRIGATION 3). A SECOND PRODUCT WAS USED BUT ALSO BROKE AFTER 10 MINUTES OF USE. THE MAXILLARY SINUS AND ROOT OF THE TIP WERE TOUCHING AND THAT MAY HAVE PUT A STRAIN ON THE PRODUCT. A THIRD PRODUCT WAS USED TO COMPLETE THE SURGERY, AND A CT SCAN WAS TAKEN TO ENSURE THAT NO PARTS WERE LEFT IN THE PATIENT. THERE WAS NO SURGICAL DELAY OR INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25125651 ↗MalfunctionMar 30, 2026Calcified; Device Reprocessing Problem
THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3006697299-2026-00028: A FACILITY REPORTED THAT THE LOANER CUSA CLARITY 23KHZ HANDPIECE (C7023P) HAS CALCIFICATION ON ONE END AND THE OTHER LOAN HANDPIECE HAS RUST/BIOBURDEN. ADDITIONAL INFORMATION WAS LATER RECEIVED AS FOLLOWS: "THE LOAN HANDPIECES WERE SUPPOSED TO BE USED WITH CONSOLE AS PART OF A NEW TRIAL AT THE HOSPITAL AND WHEN THE ISSUE WAS IDENTIFIED, THE CSSD TEAM AT THE HOSPITAL DID NOT PROCESS THE HANDPIECES FOR THE TRIAL TO COMMENCE. THE CASE WENT AHEAD AS PLANNED USING OTHER EQUIPMENT AND THERE WAS NO DELAY TO SURGERY FOR THE PATIENT. THEY DID NOT END UP USING THOSE HANDPIECES FOR SURGERY AND THEREFORE NO PATIENT IMPACT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24716706 ↗MalfunctionMar 30, 2026Material Split, Cut or Torn
A FACILITY REPORTED THAT DURING THE SURGERY (PITUITARY TUMOR), THE CANNULA SPLIT, CAUSING SMALL PIECES OF PLASTIC TO BE LOST, WHICH WERE NEVERTHELESS ASPIRATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715945 ↗MalfunctionMar 30, 2026Calcified; Device Reprocessing Problem
THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3006697299-2026-00029: A FACILITY REPORTED THAT THE LOANER CUSA CLARITY 23KHZ HANDPIECE (C7023P) HAS CALCIFICATION ON ONE END AND THE OTHER LOAN HANDPIECE HAS RUST/BIOBURDEN. ADDITIONAL INFORMATION WAS LATER RECEIVED AS FOLLOWS: "THE LOAN HANDPIECES WERE SUPPOSED TO BE USED WITH CONSOLE AS PART OF A NEW TRIAL AT THE HOSPITAL AND WHEN THE ISSUE WAS IDENTIFIED, THE CSSD TEAM AT THE HOSPITAL DID NOT PROCESS THE HANDPIECES FOR THE TRIAL TO COMMENCE. THE CASE WENT AHEAD AS PLANNED USING OTHER EQUIPMENT AND THERE WAS NO DELAY TO SURGERY FOR THE PATIENT. THEY DID NOT END UP USING THOSE HANDPIECES FOR SURGERY AND THEREFORE NO PATIENT IMPACT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715779 ↗MalfunctionMar 30, 2026Erratic or Intermittent Display
MalfunctionMar 13, 2026Erratic or Intermittent Display; Operating System Becomes Nonfunctional
AN AUTHORIZED DISTRIBUTOR REPORTED THAT DURING SURGERY, THE CUSTOMER EXPERIENCED A TECHNICAL ISSUE WITH THE NEWLY UPDATED SOFTWARE ON THE C7000 CUSA CLARITY CONSOLE. AT THE START OF THE PROCEDURE, ALL SCREEN FUNCTIONS WERE OPERATING NORMALLY. HOWEVER, AFTER APPROXIMATELY 10 MINUTES, THE DISPLAY BECAME LOCKED AND THEY WERE UNABLE TO CHANGE OR ACCESS ANY FUNCTIONS. THERE WAS MORE THAN 30 MINUTES SURGICAL DELAY DURING WHICH THEY HAD TO SWITCH OFF AND, ON THE DEVICE, TO CHANGE THE SETTINGS. THERE WAS NO PATIENT INJURY. NAME OF HOSPITAL - (B)(6) HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24599453 ↗MalfunctionMar 9, 2026Inability to Irrigate
AN AUTHORIZED DISTRIBUTOR REPORTED THAT THE CUSA CLARITY 36KHZ HANDPIECE (C7036) HAD UNCONTROLLED IRRIGATION, EVEN WHEN LOW SETTINGS WERE CONFIGURED. THE HANDPIECE WAS REPLACED TO UNDERSTAND EXACTLY WHERE THE PROBLEM WAS, AS INITIALLY IT WAS THOUGHT THE ISSUE WAS WITH THE CONSOLE. THE PROCEDURE WAS THEN COMPLETED, BUT THERE WAS SURGICAL DELAY OF MORE THAN 30 MINUTES WHILE THEY WERE TRYING TO IDENTIFY EXACTLY WHAT THE PROBLEM WAS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24547059 ↗MalfunctionFeb 13, 2026Energy Output Problem
MalfunctionFeb 6, 2026No Display/Image
AN AUTHORIZED DISTRIBUTOR REPORTED THAT THE TOUCH SCREEN OF THE CUSA CLARITY CONSOLE (C7000) FAILED DURING A MENINGIOMA SURGERY WHILE THE PATIENT WAS ALREADY UNDER ANESTHESIA. THE SURGERY WAS COMPLETED WITHOUT THE DEVICE AS NO REPLACEMENT DEVICE WAS AVAILABLE. AS A RESULT, THE SURGERY TIME WAS PROLONGED BY APPROXIMATELY 30 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24278695 ↗MalfunctionJan 29, 2026Erratic or Intermittent Display
MalfunctionJan 29, 2026Erratic or Intermittent Display
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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