CUSA® Clarity C7000Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10381780126232), received between May 26, 2021 and May 15, 2026 — classified as 4 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Intermittent Communication Failure” (8 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 6, 2026Open, Classified

   Software issue that renders the touch screen unresponsive.

   Z-1828-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMar 30, 2026Erratic or Intermittent Display

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715158 ↗
• 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 ↗
• 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

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208970 ↗
• MalfunctionJan 29, 2026Erratic or Intermittent Display

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208968 ↗
• MalfunctionJan 29, 2026Erratic or Intermittent Display

  THIS IS 3 OF 4 REPORTS FOR THE CONSOLE (B)(6) USED IN PRIOR/SUBSEQUENT SURGERIES TO THE (B)(6) 2025 SURGERY AND LINKED TO MFG REPORT NOS: A FACILITY REPORTED MULTIPLE TOUCHSCREEN MALFUNCTIONS WERE REPORTED ON TWO CONSOLES(B)(6). THE TOUCHSCREEN INTERMITTENTLY FROZE DURING SURGICAL PROCEDURES, PREVENTING THE OPERATOR FROM ADJUSTING SETTINGS. THE FAILURES OCCURRED ACROSS MULTIPLE PATIENTS AND MULTIPLE PROCEDURES. A TEMPORARY RECOVERY WAS CONSISTENTLY ACHIEVED BY TURNING THE DEVICE OFF AND ON, WHICH RESTORED TOUCH FUNCTIONALITY FOR A LIMITED PERIOD. BOTH CONSOLES WERE USED ALTERNATELY DEPENDING ON WHICH ONE WAS FUNCTIONING AT A GIVEN MOMENT. THIS REPORT IS BECAUSE THE FACILITY MENTIONED RECURRENCE THAT SERIAL# (B)(6) WAS INVOLVED IN SEVERAL SURGERIES. PER FACILITY: ¿THE ISSUE OCCURRED IN PROCEDURES AFTER (B)(6) 2025 AND HAD LIKELY OCCURRED EVEN BEFORE THAT DATE. FOR THE SUBSEQUENT PROCEDURES, THIS CAUSED SOME DELAY EACH TIME. WE DID NOT TIME IT PRECISELY, BUT WE ESTIMATE THAT THIS ALSO CAUSED APPROXIMATELY 45 MINUTES OF DELAY PER PROCEDURE.¿ NO PATIENT INJURIES WERE REPORTED IN ANY OF THE PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208965 ↗
• MalfunctionJan 29, 2026Erratic or Intermittent Display

  THIS IS 1 OF 4 REPORTS FOR THE CONSOLE (B)(6) USED IN SURGERY ON (B)(6) 2025, AND LINKED TO MFG REPORT NOS: 3006697299-2026-00003, 3006697299-2026-00004, 3006697299-2026-00005. A FACILITY REPORTED MULTIPLE TOUCHSCREEN MALFUNCTIONS WERE REPORTED ON TWO CONSOLES (B)(6). THE TOUCHSCREEN INTERMITTENTLY FROZE DURING SURGICAL PROCEDURES, PREVENTING THE OPERATOR FROM ADJUSTING SETTINGS. THE FAILURES OCCURRED ACROSS MULTIPLE PATIENTS AND MULTIPLE PROCEDURES. A TEMPORARY RECOVERY WAS CONSISTENTLY ACHIEVED BY TURNING THE DEVICE OFF AND ON, WHICH RESTORED TOUCH FUNCTIONALITY FOR A LIMITED PERIOD. BOTH CONSOLES WERE USED ALTERNATELY DEPENDING ON WHICH ONE WAS FUNCTIONING AT A GIVEN MOMENT. THE ISSUE EXPERIENCED BY THE CUSTOMER LED TO INCREASED SURGERY TIME OF APPROXIMATELY 45 MINUTES. HOWEVER, THE SURGERIES WERE CONTINUED AND COMPLETED IN THE MANNER DESCRIBED ABOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208962 ↗
• MalfunctionOct 31, 2025Noise, Audible; Noise, Audible

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437753 ↗
• MalfunctionOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 23325139 ↗
• MalfunctionApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS 2 OF 2 REPORTS FOR THE CONCOMITANT CUSA CLARITY CONSOLE (C7000), AND LINKED TO MFG REPORT NUMBER 3006697299-2025-00046: A FACILITY REPORTED THAT DURING A SURGICAL PROCEDURE FOR TRANSSPHENOIDAL MICROADENOMA RESECTION, THE SPECIALIST BEGAN USING THE ASPIRATOR AND STATED THAT THE TIP FELT TOO HOT. THIS WAS CONFIRMED BY THE SURGICAL CONSULTANT, WHO NOTED THAT THE TIP FELT HOT, BUT THE HANDPIECE WAS AT A NORMAL TEMPERATURE. THE PARAMETERS ON THE SCREEN WERE CHECKED AND WERE: AMPLITUDE: 80, ASPIRATION: 100, FLUID: 3 , SELECT TISSUE: LOW. ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: 1. PATIENT'S CONDITION: STABLE, NO COMPLICATIONS. 2. WAS THE SURGERY SUCCESSFUL? YES, THE SURGERY WAS SUCCESSFUL. 3. DID THE PATIENT REQUIRE FURTHER MEDICAL ATTENTION OR SURGERY? NO. 4. THERE IS A COMMENT: "I ALSO WANT TO REPORT THAT THIS IS THE SECOND TIME THIS TYPE OF HEATING HAS OCCURRED." WAS IT THE SAME HANDPIECE OR A DIFFERENT ONE? THE INCIDENT OCCURRED WITH THE SAME EQUIPMENT AND THE SAME HANDPIECE. 5. WAS A COMPLAINT FILED FOR THE PREVIOUS CASE? NO, THE FIRST SITUATION WAS NOT FORMALLY REPORTED TO COMPLAINTS. THE BIOMEDICAL DEPARTMENT TESTED THE EQUIPMENT, AND IT WORKED PROPERLY, AND THERE WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934100 ↗
• InjuryApr 17, 2025Overheating of Device; Overheating of Device

  THIS REPORT IS 1 OF 2 LINKED TO MFG REPORT NUMBER 3006697299-2025-00045: A FACILITY REPORTED THAT DURING THE SURGICAL PROCEDURE FOR TRANSSPHENOIDAL MICROADENOMA RESECTION, THE SPECIALIST BEGAN USING THE ASPIRATOR AND STATED THAT THE TIP FELT TOO HOT. THIS WAS CONFIRMED BY THE SURGICAL CONSULTANT, WHO NOTED THAT THE TIP FELT HOT, BUT THE HANDPIECE WAS AT A NORMAL TEMPERATURE. THE PARAMETERS ON THE SCREEN WERE CHECKED AND WERE: AMPLITUDE: 80; ASPIRATION: 100; FLUID: 3; SELECT TISSUE: LOW. AT THE END OF THE PROCEDURE, THE DOCTOR DECIDED TO USE THE ASPIRATOR AGAIN, CHANGING THE AMPLITUDE TO 90 AND THE IRRIGATION TO 2. THE DOCTOR USED THE ASPIRATOR FOR ONE MINUTE AND LEFT IT ON THE DRESSINGS. AT THAT POINT, IT BECAME CLEAR THAT THE TIP WAS TOO HOT, AND THE ENTIRE UNIT WAS DISASSEMBLED. DUE TO THE EXTREME HEATING OF THE TIP, DR. [REDACTED] INDICATED THAT THE PATIENT HAD SUFFERED A DURAL RUPTURE. ADDITIONALLY, A BURN WAS SEEN ON THE UROLOGY EQUIPMENT CABLE WHEN THE HANDPIECE WAS PLACED ON THE FIELDS, INDICATING THAT THE TIP WAS QUITE HOT. TESTS WERE CONDUCTED WITH THE BIOMEDICAL ENGINEER, WHO CONTACTED INTEGRA'S TECHNICAL DEPARTMENT TO RESOLVE THE ISSUE, WHICH IS CURRENTLY UNDERWAY. I ALS

  Patient problems: Rupture

  MAUDE report 21856433 ↗
• MalfunctionFeb 13, 2025Failure to Power Up; Failure to Power Up

  A FACILITY REPORTED THAT THE POWER ON THE CUSA CLARITY CONSOLE (C7000) WAS NOT WORKING DURING A CRANIOTOMY PROCEDURE WITH TUMOR RESECTION. THE HANDPIECE WAS DRIPPING AND THEY REBOOTED THE DEVICE, BUT STILL THE DEVICE WAS NOT ABLATING. THERE WAS A DELAY FOR AROUND 20 TO 30 MINUTES AND THERE WAS UNNECESSARY BLEEDING THAT OCCURRED DUE TO NOT BEING ABLE TO START GETTING THE TUMOR OUT WHEN THE SURGEON WAS READY; HOWEVER, NO INJURY WAS CAUSED TO THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21380296 ↗
• MalfunctionNov 27, 2024Erratic or Intermittent Display; Intermittent Loss of Power; Erratic or Intermittent Display; Intermittent Loss of Power

  N/A.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20803093 ↗
• MalfunctionNov 22, 2024Crack; Crack

  A FACILITY REPORTED THAT PRIOR TO A SURGERY, IT WAS DISCOVERED THAT THE CARTRIDGE DOOR OF THE CUSA CLARITY WAS BROKEN. A REPLACEMENT DEVICE WAS NOT USED AS ONE WAS NOT PRESENT IN THE FACILITY. THE DEPARTMENT STAFF MANAGED TO UNLOCK THE DOOR OF THE DEVICE THAT REMAINED 'STUCK' AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS INCREASED SURGICAL TIME OF 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20758999 ↗
• MalfunctionOct 28, 2024Intermittent Communication Failure; Intermittent Communication Failure

  A FACILITY REPORTED THAT DURING INTRACRANIAL MALIGNANT TUMOR REMOVAL SURGERY, THE CUSA CLARITY CONSOLE (C7000) DISPLAYED AN ERROR MESSAGE WHEN TURNING ON THE DEVICE. THE DEVICE WAS TURNED OFF, AND THEN TURNED BACK ON AFTER UNPLUGGING IT FOR 15 MINUTES BUT THERE WAS NO SIGN OF IMPROVEMENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. A CEM NOSECONE WAS NOT USED WHEN THE ERROR OCCURRED. ALSO, A SPECIFIC PLACEMENT OF A GENERATOR FROM THE DEVICE IS UNKNOWN, THOUGH A GENERATOR WAS PLACED IN THE SAME ROOM. THERE WAS MORE THAN 30 MINUTES OF SURGICAL DELAY; HOWEVER NO ADVERSE CONSEQUENCES TO THE PATIENT WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20544601 ↗
• MalfunctionOct 15, 2024Intermittent Communication Failure; Intermittent Communication Failure

  A FACILITY REPORTED THAT WHEN TURNING ON THE CUSA CLARITY CONSOLE (C7000) DURING AN AORTIC VALVE REPLACEMENT PROCEDURE, IT DISPLAYED AN ALARM. THE DEVICE WAS REBOOTED, BUT IT COULD NO LONGER BE USED. THERE WAS A DELAY OF MORE THAN 30 MINUTES; HOWEVER, NO PATIENT INJURY OCCURRED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20452154 ↗
• MalfunctionOct 15, 2024Failure to Power Up; Failure to Power Up

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20451970 ↗
• MalfunctionOct 3, 2024Intermittent Communication Failure; Intermittent Communication Failure

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20362600 ↗
• MalfunctionSep 24, 2024Intermittent Communication Failure; Intermittent Communication Failure

  A FACILITY REPORTED THAT DURING A BRAIN TUMOR REMOVAL SURGERY, THE CUSA CLARITY CONSOLE (C7000) DISPLAYED AN ERROR MESSAGE. THEY ATTEMPTED TO REBOOT THE DEVICE SEVERAL TIMES, BUT THE ISSUE WAS NOT RESOLVED. AS A RESULT, ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS MORE THAN 30 MINUTES DELAY DUE TO PRODUCT PROBLEM; HOWEVER, THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20295710 ↗
• MalfunctionSep 24, 2024Intermittent Communication Failure; Intermittent Communication Failure

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20295601 ↗
• MalfunctionSep 24, 2024Intermittent Communication Failure; Intermittent Communication Failure

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20294354 ↗
• MalfunctionSep 24, 2024Intermittent Communication Failure; Intermittent Communication Failure

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292493 ↗
• MalfunctionSep 6, 2024Computer Software Problem; Computer Software Problem

  A FACILITY REPORTED THAT THE CUSA CLARITY CONSOLE (C7000) DISPLAYED AN ERROR CODE PRIOR TO A BRAIN TUMOR REMOVAL SURGERY. THE DEVICE WAS REBOOTED, BUT IT COULD NOT BE USED, AND ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS MORE THAN 30 MINUTES DELAY DUE TO PRODUCT PROBLEM. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE OBSERVED. A COMPANY REPRESENTATIVE VISITED THE FACILITY TO CHECK THE DEVICE ON THE SAME DAY, RE-INSTALLED THE SOFTWARE AND CONFIRMED THE NORMALITY OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20159146 ↗
• MalfunctionSep 6, 2024Computer Software Problem; Computer Software Problem

  THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3006697299-2024-00136: A FACILITY REPORTED THAT A SYSTEM ERROR MESSAGE OCCURRED ON CUSA CLARITY CONSOLE (C7000) PRIOR TO SURGERY. IT WAS REBOOTED, BUT IT COULD NOT BE USED, AND ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. SURGICAL DELAY WAS MORE THAN 30 MINUTES. THE FOLLOWING DAY, A COMPANY REPRESENTATIVE VISITED THE FACILITY TO CHECK THE DEVICE, AND RE-INSTALLED THE SOFTWARE WHICH RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20159128 ↗