CUSA® Clarity C7300Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10381780126287), received between Jan 19, 2023 and Jan 31, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Inability to Irrigate” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 31, 2025Device Handling Problem; Device Handling Problem

  N/A.

  Patient problems: Bacterial Infection

  MAUDE report 21283179 ↗
• MalfunctionOct 3, 2024Inability to Irrigate; Inability to Irrigate

  THIS REPORT IS LINKED TO MFG REPORT NUMBER 3006697299-2024-00144 AND 3006697299-2024-00152, AND IS FOR THE 2ND SURGERY: AFTER RECEIVING ADDITIONAL INFORMATION ON MFG REPORT# 3006697299-2024-00144 REGARDING IRRIGATION ISSUES DURING SURGERY INVOLVING C7300 CUSA CLARITY QUICK CONNECT TUBING (C7300) INDICATING THAT THE DEVICE ONLY WORKED SEQUENTIALLY WHEN IRRIGATION WAS SET TO A MAXIMUM SPEED OF 20 ML/MIN), THE CUSTOMER EXPLAINED THAT THIS TYPE OF ISSUE WHICH INCREASED THE DURATION OF SURGERY BY MORE THAN 30 MINUTES CONTINUED TO HAPPEN AGAIN AND OCCURRED DURING 3 SURGICAL PROCEDURES IN TOTAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20362925 ↗
• MalfunctionOct 3, 2024Inability to Irrigate; Inability to Irrigate

  THIS REPORT IS LINKED TO MFG REPORT NUMBER 3006697299-2024-00144 AND 3006697299-2024-00151, AND IS FOR THE 3RD SURGERY: AFTER RECEIVING ADDITIONAL INFORMATION ON MFG REPORT# 3006697299-2024-00144 REGARDING IRRIGATION ISSUES DURING SURGERY INVOLVING C7300 CUSA CLARITY QUICK CONNECT TUBING (C7300) INDICATING THAT THE DEVICE ONLY WORKED SEQUENTIALLY WHEN IRRIGATION WAS SET TO A MAXIMUM SPEED OF 20 ML/MIN), THE CUSTOMER EXPLAINED THAT THIS TYPE OF ISSUE WHICH INCREASED THE DURATION OF SURGERY BY MORE THAN 30 MINUTES CONTINUED TO HAPPEN AGAIN AND OCCURRED DURING 3 SURGICAL PROCEDURES IN TOTAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20362100 ↗
• MalfunctionSep 24, 2024Inability to Irrigate; Inability to Irrigate

  A FACILITY REPORTED THAT THEY EXPERIENCED IRRIGATION ISSUES WITH THE CUSA CLARITY QUICK CONNECT TUBING SET (C7300) DURING A SURGICAL PROCEDURE. THE IRRIGATION ONLY WORKED SEQUENTIALLY WHEN IRRIGATION WAS SET AT MAX SPEED 20 ML/MIN. CUSTOMER TRIED SWITCHING EVERY PART (MACHINE, PEDAL, HANDPIECE, SALINE SOLUTION, TIP) AND AFTER SWITCHING THE TUBING, THE MACHINE STARTED WORKING NORMALLY. THIS FAULT OCCURRED TWICE AND THE CHANGING OF THE TUBING HAS WORKED BOTH TIMES WHICH LED THEM TO BELIEVE THAT THE LOT HAS A MANUFACTURING ISSUE. THE SURGERY WAS DELAYED BY APPROXIMATELY 1-2 HOURS. THE FACILITY HAS DISCARDED THE USED, CONTAMINATED TUBING SO THEY ARE NOT AVAILABLE TO BE SENT FOR EVALUATION. HOWEVER, THE REMAINING STERILE TUBING WILL BE SENT FOR INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292870 ↗
• MalfunctionSep 7, 2023Break; Break

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17702493 ↗
• MalfunctionJan 19, 2023Failure to Align; Failure to Align

  A FACILITY REPORTED THAT PRIOR TO A LIVER RESECTION PROCEDURE, THE CUSA CLARITY QUICK CONNECT TUBING SET (C7300) IRRIGATION TUBE WAS MISALIGNED. SURGICAL TIME WAS EXTENDED MORE THAN 30 MINUTES. THE DEVICE WAS CHANGED TO A NEW ONE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16211395 ↗