CUSA® Clarity C7036Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10381780126263), received between Jun 16, 2022 and Jul 27, 2026 — classified as 2 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (15 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50025484 ↗
• 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

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333091 ↗
• MalfunctionNov 6, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  A FACILITY REPORTED THAT THE CUSA CLARITY 36KHZ HANDPIECE (C7036) IS DEFECTIVE AND PRODUCED AN ERROR MESSAGE DURING SURGERY. THIS INCIDENT INCREASED THE SURGERY TIME FOR 30 MINUTES. THE SURGERY TEAM USED ANOTHER EQUIPMENT TO FINISH THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490845 ↗
• MalfunctionOct 24, 2025Overheating of Device; Overheating of Device

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383836 ↗
• MalfunctionSep 22, 2025Overheating of Device; Overheating of Device

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23110514 ↗
• MalfunctionSep 22, 2025Intermittent Communication Failure; Intermittent Communication Failure

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23109752 ↗
• MalfunctionSep 5, 2025Overheating of Device; Overheating of Device

  A FACILITY REPORTED THAT THE POOL CUSA CLARITY 36KHZ HANDPIECE (C7036P) HEATS UP. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22984215 ↗
• MalfunctionJul 2, 2025Overheating of Device; Overheating of Device

  A FACILITY REPORTED THAT THE CUSA CLARITY 36KHZ HANDPIECE (C7036) WAS OVERHEATING. THE CIRCUMSTANCES OF THE EVENT IS NOT KNOWN; HOWEVER, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385340 ↗
• MalfunctionJun 11, 2025Overheating of Device; Overheating of Device

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22185323 ↗
• MalfunctionJun 10, 2025Crack; Crack

  A FACILITY REPORTED THAT DURING OPEN RADICAL HYSTERECTOMY PROCEDURE, THE CONNECTING PART OF THE TUBE AND THE CUSA CLARITY 36KHZ HANDPIECE (C7036) WAS BROKEN DURING SURGERY. SINCE THE DAMAGE OF THE RESIN WAS PARTIAL, THE PHYSICIAN CONTINUED THE PROCEDURE USING THE DEVICE. NO PARTS WERE REMAINING IN THE PATIENT¿S BODY; ALL THE BROKEN PARTS WERE RECOVERED. THERE WAS NO SURGICAL DELAY, AND NO ADVERSE CONSEQUENCES TO THE PATIENT WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180543 ↗
• MalfunctionMay 8, 2025Output below Specifications; Output below Specifications

  A FACILITY REPORTED THAT DURING USE OF THE CUSA CLARITY 36HZ HANDPIECE (C7036) EVEN IF THE AMPLITUDE WAS SET TO MAXIMUM, WITH SELECTIVITY DEACTIVATED, THE OUTPUT DID NOT EXCEED 20%. THERE WAS NO PATIENT INJURY; HOWEVER, THERE WAS INCREASED SURGERY TIME OF MORE THAN 30 MINUTES. ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: HOSPITAL IS (B)(6). WHAT TYPE OF PROCEDURE? LIVER SURGERY REMOVAL 4° SEGMENT. HOW DID THE MEDICAL TEAM FINALIZE THE PROCEDURE? THEY COULD ACCOMPLISH SURGERY TO THE END. DID THEY USE ANOTHER AVAILABLE HANDPIECE/ SWITCH TO ANOTHER METHOD? NO ANSWER RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985158 ↗
• MalfunctionApr 17, 2025Output below Specifications; Output below Specifications

  A FACILITY REPORTED THAT THE AMPLITUDE OF CUSA CLARITY 36KHZ HANDPIECE (C7036) DID NOT RISE OVER 10% WHEN IT WAS SUPPOSED TO BE RISING AROUND 40% DURING A BRAIN TUMOR REMOVAL SURGERY.. IT WAS REBOOTED AND IT FAILED THE TEST. ACCORDING TO THE ERROR MESSAGE, THE DISPOSABLES NEEDED TO BE REPLACED. THE TIP WAS REPLACED TWICE BUT IT FAILED THE TEST. AFTER REPLACING THE HANDPIECE AND USING THE SAME TIPS, IT PASSED THE TEST. ANOTHER SUCTIONING DEVICE WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857765 ↗
• MalfunctionNov 27, 2024Wireless Communication Problem; Wireless Communication Problem

  A FACILITY REPORTED THAT TIP FREQUENCY OPTIMIZATION FAILED ON THE CUSA CLARITY 36KHZ HANDPIECE (C7036). PATIENT WAS UNDER ANESTHESIA AND THERE WAS INCREASED SURGERY TIME OF 30 MINUTES OR MORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20803049 ↗
• MalfunctionJul 8, 2024Smoking; Smoking

  A FACILITY RETURNED THE CUSA CLARITY CONSOLE- POOL UNIT (C7000P) TO OUR SERVICE & REPAIR DEPARTMENT, AND DURING EVALUATION BY AN INTEGRA TECHNICIAN, THE UNIT WAS IN WORKING ORDER, BUT THEY NOTICED THAT IT HAD A STRONG SMOKY ODOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697673 ↗
• MalfunctionMay 16, 2024Overheating of Device; Overheating of Device

  A FACILITY REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE CUSA CLARITY 36KHZ HANDPIECE (C7036) BECAME HOT. THE CLINICIANS CHANGED OUT THE HANDPIECE. NO INFORMATION ON PATIENT/USER INJURY OR SURGICAL DELAY HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19333655 ↗
• MalfunctionMay 2, 2024Overheating of Device; Overheating of Device

  A FACILITY REPORTED THAT DURING A NEUROSURGICAL PROCEDURE, THE CUSA CLARITY HANDPIECE (C7036) PRESENTED WITH OVERHEATING DURING SURGERY. HOWEVER, THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19235311 ↗
• MalfunctionMar 8, 2024Overheating of Device; Overheating of Device

  A FACILITY REPORTED THAT DURING A BRAIN TUMOR PROCEDURE, THE CUSA CLARITY 36KHZ HANDPIECE (C7036) WAS HEATING UP AND WAS NOT WORKING FOR THEM. THE TUMOR WAS EXTREMELY FIBROUS AND THEY ENDED UP SWITCHING TO A SHEAR TIP WHICH HELPED A BIT BUT STILL TOOK QUITE A WHILE TO RESECT THE TUMOR. THE SURGEON WAS HOLDING THE HANDPIECE WITH A WET SPONGE BECAUSE OF THE HEAT FROM THE HANDPIECE; HOWEVER, IT IS NOT KNOWN WHERE EXACTLY THE SURGEON WAS HOLDING THE HANDPIECE. THERE WAS NO PATIENT INJURY AND IT IS UNKNOWN IF THERE WAS SURGICAL DELAY OR INCREASED SURGERY TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18871645 ↗
• MalfunctionAug 11, 2023Overheating of Device; Overheating of Device

  A FACILITY REPORTED THAT THE CUSA CLARITY 36KHZ HANDPIECE (C7036) WAS OVERHEATING. NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17512009 ↗
• InjuryJul 13, 2023Overheating of Device; Overheating of Device

  A FACILITY REPORTED THAT DURING THORACIC MENINGIOMA HIGH SURGERY, THE CUSA CLARITY 36KHZ HANDPIECE (C7036) OVERHEATED AND BURNED THE PATIENT'S DURA MATER. THEY APPLIED MEDICAL GLUE TO CLOSE IT, AND COMPLETED THE SURGERY BY COAGULATION WITH SCISSORS. THE EVENT LED TO AN INCREASE OF SURGERY TIME OF ONE HOUR OR MORE. THERE WAS A RISK OF LEAK AND RISK OF MENINGOCELE. THE PATIENT WAS AN ELDERLY PERSON.

  Patient problems: Burn(s)

  MAUDE report 17321960 ↗
• MalfunctionMay 11, 2023Overheating of Device; Overheating of Device

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16916581 ↗
• InjuryMay 5, 2023Overheating of Device; Overheating of Device

  THIS IS 1 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3006697299-2023-00045; 3006697299-2023-00046. A FACILITY REPORTED THAT CUSA CLARITY 36KHZ HANDPIECE (C7036) WAS USED DURING A "CRANIOTOMY OCCIPITAL RIGHT SIDE" FOR TUMOR REMOVAL, AND THE PATIENT RECEIVED A SUPERFICIAL BURN ON THE RIGHT SCAPULA AND WAS GIVEN FIRST AID TREATMENT WITH BETADINE AND A DUODERM DRESSING. THE HANDPIECE WAS APPARENTLY RESTED ON THE SCAPULA ON TOP OF THE SURGICAL DRAPE. THE SURGEON'S GOWN HAD A BURN THROUGH HIS SURGICAL GOWN BUT HAD NO PERSONAL INJURY. THERE WAS NO DELAY IN SURGERY REPORTED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 16878797 ↗
• MalfunctionApr 13, 2023Overheating of Device; Overheating of Device

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16738771 ↗
• MalfunctionApr 6, 2023Overheating of Device; Overheating of Device

  A FACILITY REPORTED THAT EXCESSIVE HEAT ON THE CUSA CLARITY 36KHZ HANDPIECE (C7036) WAS DENOTED DURING USE. NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16689791 ↗
• MalfunctionMar 30, 2023Suction Problem; Power Problem; Suction Problem; Power Problem

  A FACILITY REPORTED THAT DURING AN OPERATION WHILE IT WAS WORKING ON A PATIENT, THE SUCTION ON THE CUSA CLARITY 6KHZ HANDPIECE (C7036) STOPPED AND SHOWED ON THE SCREEN "ERROR: HANDPIECE FAILURE." DISCONNECT AND RECONNECT HANDPIECE. REPLACE HANDPIECE IF ERROR PERSIST. 2304 US_INVALID_CRC_ HANDPIECE." THE SURGEON WHO IS THE MAIN USER OF CUSA IN THE COUNTRY WAS FORCED TO STOP THE OPERATION AND WAIT UNTIL THE BACKUP HANDPIECE WAS STERILIZED AND BROUGHT TO THE HOSPITAL. THIS RESULTED TO THE DELAY OF THE OPERATION FOR AT LEAST 90 MINUTES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16645772 ↗