CUSA® Clarity C7411SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10381780126355), received between Jul 17, 2021 and Jul 27, 2026 — classified as 8 malfunctions.

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

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Crack

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50025489 ↗
• MalfunctionMar 20, 2025Material Fragmentation; Material Fragmentation

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 21657340 ↗
• MalfunctionAug 26, 2024Crack; Crack

  A FACILITY REPORTED THAT DURING SURGERY, THE TIP OF THE CUSA CLARITY 36KHZ CURVED EXTENDED MICROTIP (C7411S) BROKE INSIDE THE PATIENT'S HEAD. THE SURGEON HAD TO STOP THE OPERATION AND REPLACE THE TIP. THERE WAS NO SIGNIFICANT INCREASED SURGERY TIME, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20065068 ↗
• MalfunctionFeb 1, 2024Break; Break

  A FACILITY REPORTED THAT DURING USE, THE TIP OF THE CUSA CLARITY 36KHZ CURVED EXTENDED MICROTIP (C7411S) BROKE. THERE WAS A POSSIBILITY THAT PART OF THE PRODUCT REMAINED IN THE PATIENT¿S BODY; THEREFORE, A CT SCAN WAS PERFORMED WHICH CONFIRMED THE ABSENCE OF ANY REMAINING PRODUCT IN THE PATIENT¿S BODY. THE SAME DEVICE WAS UTILIZED TO FINALIZE THE SURGERY. NO INFORMATION WAS PROVIDED ON THE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18628398 ↗
• MalfunctionJan 5, 2024Separation Problem; Separation Problem

  A FACILITY REPORTED THAT PARTS OF THE FLUE OF THE CUSA CLARITY 36KHZ CURVED EXTENDED MICROTIP¿ (5 PACK) (C7411S) WERE SEPARATED. NO PATIENT INJURY HAS BEEN REPORTED; HOWEVER, THERE WAS SURGICAL DELAY OF MORE THAN 30 MINUTES. NO FURTHER INFORMATION WAS PROVIDED BY HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18461019 ↗
• MalfunctionOct 12, 2023Suction Problem; Suction Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17923434 ↗
• MalfunctionJan 30, 2023Break; Device Fell

  DURING THE PROCEDURE, THE C7411S CUSA CLARITY 36KHZ CURVED EXTENDED MICROTIP¿ (5 PACK) BROKE AT A POSITION ABOUT 3 CM FROM THE TIP AND FELL INTO THE SURGICAL SITE. ALL BROKEN PARTS WERE REMOVED FROM THE SURGICAL SITE; HOWEVER, IT IS NOT KNOWN HOW SAME WAS REMOVED. THEY CHANGED TO ANOTHER DEVICE, AND THE PROCEDURE WAS COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16268145 ↗
• MalfunctionJul 17, 2021Suction Problem; Suction Problem

  A NURSE REPORTED THAT CUSA CLARITY MICROTIP (C7411S) HAS NO SUCTION FROM THE TIP DURING A NEUROSURGERY PROCEDURE. THERE WAS A 30 TO 40 MINUTES SURGERY DELAY WITH NO PATIENT INJURY REPORTED. THE INCIDENT WAS NOTED AT THE START OF THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12186155 ↗