CUSA® Clarity C7023Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10381780466314), received between Feb 17, 2022 and Mar 30, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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, 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 ↗
• MalfunctionJun 7, 2024Device Contamination with Body Fluid; Device Contamination with Body Fluid

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3006697299-2024-00080: A FACILITY REPORTED THAT WHEN THEY OPENED THE RENTAL CUSA CLARITY 23KHZ HANDPIECES (C7023P) UPON ARRIVAL, THERE WAS A SIGNIFICANT AMOUNT OF DRIED BLOOD IN THE IRRIGATION CANAL WHICH WAS MOST LIKELY LEFT OVER FROM THE PREVIOUS RENTAL/LOANER USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19489569 ↗
• MalfunctionJun 7, 2024Device Contamination with Body Fluid; Device Contamination with Body Fluid

  THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3006697299-2024-00081: A FACILITY REPORTED THAT WHEN THEY OPENED THE RENTAL CUSA CLARITY 23KHZ HANDPIECES (C7023P) UPON ARRIVAL, THERE WAS A SIGNIFICANT AMOUNT OF DRIED BLOOD IN THE IRRIGATION CANAL WHICH WAS MOST LIKELY LEFT OVER FROM THE PREVIOUS RENTAL/LOANER USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19485128 ↗
• MalfunctionJan 12, 2024Overheating of Device; Manufacturing, Packaging or Shipping Problem; Overheating of Device; Manufacturing, Packaging or Shipping Problem

  AN AUTHORIZED DISTRIBUTOR REPORTED THAT DURING INITIAL TESTING PROCEDURE, AN OUT OF BOX FAILURE OCCURRED ON THE CUSA CLARITY 23 KHZ HANDPIECE (C7023): ONLY VIBRATED TO 43%, HAD EXCESSIVE NOISE AND ALSO OVERHEATED. THE HANDPIECE WAS REPLACED. THERE WAS NO INJURY AND NO CONSIDERABLE DELAYS ON SURGERY WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18508872 ↗
• MalfunctionJul 28, 2023Overheating of Device; Overheating of Device

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413827 ↗
• InjuryDec 5, 2022Overheating of Device; Overheating of Device

  A FACILITY REPORTED THAT CUSA CLARITY 23KHZ HANDPIECE (C7023) WAS NOT COOLING DURING A HEPATECTOMY PROCEDURE. THE PATIENT SUSTAINED AN ABDOMINAL BURN(NOT SEVERE, BURNT THE TISSUE MORE THAN NORMAL) WHILE THE ASSISTANT HAD A FINGERTIP BURN (NOT SEVERE, BLISTERS ON THEIR FINGER). NO SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: Blister; Bowel Burn

  MAUDE report 15920800 ↗
• MalfunctionNov 23, 2022Overheating of Device; Overheating of Device

  A FACILITY REPORTED THAT THE HANDLE ON THE CUSA CLARITY 23 KHZ HANDPIECE (C7023) GETS HOT AND IS NOT WORKING PROPERLY. NO INFORMATION HAS BEEN PROVIDED ON PATIENT INVOLVEMENT, INJURY, OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15859178 ↗
• MalfunctionApr 13, 2022Temperature Problem; Temperature Problem

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3006697299-2022-00054: A FACILITY REPORTED THAT DURING REVALIDATION OF AUTOCLAVES, THE CUSA CLARITY 23 KHZ HANDPIECE (C7023) WERE TESTED, AND 7 TESTS ON THE SAME INSTRUMENT SHOWED THAT THE TEMPERATURE IN THE INSTRUMENT'S LUMEN DID NOT REACH THE CORRECT TEMPERATURE FOR STERILIZATION (134 DEGREES FOR 4 MINUTES) IN RELATION TO (B)(6) STANDARDS. THE TEMPERATURE ONLY REACHED132 DEGREES AS MAXIMUM TEMPERATURE IN A VERY SHORT TIME. THE DEVICE WAS ALREADY USED ON PATIENT WAS THIS WAS DISCOVERED, THUS THERE WAS NO PATIENT INJURY OR INCREASED SURGERY TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14105195 ↗
• MalfunctionApr 13, 2022Temperature Problem; Temperature Problem

  THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3006697299-2022-00053: A FACILITY REPORTED THAT DURING REVALIDATION OF AUTOCLAVES, THE CUSA CLARITY 23 KHZ HANDPIECE (C7023) WERE TESTED, AND 7 TESTS ON THE SAME INSTRUMENT SHOWED THAT THE TEMPERATURE IN THE INSTRUMENT'S LUMEN DID NOT REACH THE CORRECT TEMPERATURE FOR STERILIZATION (134 DEGREES FOR 4 MINUTES) IN RELATION TO DANISH AND EU STANDARDS. THE TEMPERATURE ONLY REACHED132 DEGREES AS MAXIMUM TEMPERATURE IN A VERY SHORT TIME. THE DEVICE WAS ALREADY USED ON PATIENT WAS THIS WAS DISCOVERED, THUS THERE WAS NO PATIENT INJURY OR INCREASED SURGERY TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14105188 ↗
• MalfunctionFeb 17, 2022Overheating of Device; Overheating of Device

  A FACILITY REPORTED THAT DURING AN UNSPECIFIED CASE, THE CUSA CLARITY 23 KHZ HANDPIECE (C7023) OVERHEATED. THE DEVICE WAS IN CONTACT WITH THE PATIENT; HOWEVER, NO PATIENT INJURY OR INCREASE IN SURGERY TIME WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13548706 ↗