CUSA® Clarity C7415SEARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780126447), received between Apr 3, 2025 and May 8, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionApr 3, 2025Crack; Crack

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21766204 ↗