CUSA® Clarity C7415SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10381780126379), received between Mar 18, 2022 and May 8, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Crack” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionNov 13, 2025Crack; Crack

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544019 ↗
• MalfunctionNov 10, 2025Crack; Overheating of Device; Crack; Overheating of Device

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 23513027 ↗
• MalfunctionJul 2, 2025Crack; Crack

  A FACILITY REPORTED THAT DURING A SURGICAL PROCEDURE FOR MENINGIOMA, WHEN ABLATING THE TUMOR WITH C7415S CUSA CLARITY 36KHZ CURVED EXTENDED MICROTIP¿, THE TIP OF THE DEVICE SNAPPED. SURGICAL TIME WAS NOT SIGNIFICANTLY EXTENDED DUE TO PRODUCT PROBLEM. THERE WAS THE POSSIBILITY OF THE PRODUCT REMAINING IN THE PATIENT'S BODY; HOWEVER, IT WAS CONFIRMED THAT NO BROKEN PARTS REMAINED IN THE PATIENT¿S BODY. ADDITIONAL INFORMATION SUBSEQUENTLY RECEIVED AS FOLLOWS: WAS AN X-RAY TAKEN TO ASSURE NO PARTS LEFT IN PATIENT? IF NOT, WHY NOT? UNKNOWN. WHAT ACTION TAKEN AFTER PRODUCT PROBLEM OCCURRED? (E.G. REPLACEMENT)? ANOTHER PRODUCT WAS USED TO COMPLETE THE SURGERY. PATIENT OUTCOME/STATUS. UNKNOWN IF AVAILABLE, PLEASE PROVIDE US WITH THE PATIENT INFORMATION. UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22385342 ↗
• MalfunctionApr 30, 2025Overheating of Device; Overheating of Device

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934033 ↗
• MalfunctionApr 17, 2025Overheating of Device; Overheating of Device

  THIS REPORT IS 2 OF 2 LINKED TO MFG REPORT NUMBER 3006697299-2025-00042: 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 21856737 ↗
• MalfunctionJan 3, 2025Crack; Crack

  A PHYSICIAN REPORTED THAT THE TIP (APPROXIMATELY 1CM) OF THE CUSA CLARITY 36KHZ (C7415S) BROKE OFF WHILE REMOVING THE BRAIN TUMOR. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE; THE DRILL AND THE DEVICE WAS NOT USED AT THE SAME TIME. THE BROKEN PART WAS RECOVERED. ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: THERE WERE NO PROBLEMS WITH HOW THE DOCTOR ATTACHED THE TIP. WHEN HE ATTACHED THE NEW TIP AS USUAL, NOTHING PROBLEMATIC HAPPENED. HE DID NOT PUT ANY EXCESSIVE LOAD ON THE DEVICE. SINCE THE TUMOR WAS NOT SO FIBROUS (PINEAL TUMOR), THE DEVICE WAS USED FOR LESS THAN 60 MINUTES. [(SETTING) AMPLITUDE:30-50, T/S: ON, SUCTION: AROUND 50). BIPOLAR AND DRILL WERE USED DURING A PROCEDURE, BUT THESE WERE NOT USED WITH CLARITY AT THE SAME TIME. ONLY THE SUCTION TUBE WAS USED AT THE SAME TIME. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE OBSERVED, SINCE ALL THE BROKEN PARTS WERE RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21074619 ↗
• MalfunctionFeb 16, 2024Crack; Crack

  MEDWATCH UF/IMPORTER REPORT# (B)(4) RECEIVED AS FOLLOWS: "WHILE USING THE DISPOSABLE MICRO EXTENDED CUSA TIP INTRA-NASAL. IT WAS NOTED BY THE SURGEON THE TIP BROKE OFF, ABOUT 1CM. UNCLEAR WHY THIS HAPPENED. A NEW TIP WAS GIVEN TO THE FIELD. CONTACT REP FOR FURTHER RECOMMENDATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18727949 ↗
• MalfunctionMar 18, 2022Break; Break

  A FACILITY REPORTED THAT DURING A TRANSSPHENOIDAL SURGERY, THE TIP OF THE CUSA CLARITY 36KHZ CURVED EXTENDED MICROTIP¿ PLUS (C7415S) BROKE AT THE FRONT END OF THE TIP, ABOUT ONE CM BEFORE THE END OF THE TIP. IT WAS REPORTED THAT THEY DID NOT TRY TO REMOVE BONE TISSUE, BUT SOFT TISSUE. THE BROKEN PART WAS REMOVED FROM THE PATIENT; THERE WAS NO PATIENT INJURY. THERE WAS INCREASED SURGERY TIME OF 10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13803525 ↗