CUSA® Excel C3601Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10381780025863), received between Feb 25, 2022 and May 15, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Fluid/Blood Leak

  AN AUTHORIZED DISTRIBUTOR REPORTED THAT THE AIR WAS LEAKING INSIDE THE TUBING OF THE CUSA EXCEL 36KHZ TUBING SET (C3601) DURING A PROCEDURE. THE DEVICE WAS REPLACED AND NO SURGICAL DELAY RESULTED. NO PATIENT INJURY OCCURRED, AND THE PATIENT'S CURRENT STATUS IS REPORTED TO BE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25185785 ↗
• MalfunctionSep 5, 2025Overheating of Device; Overheating of Device

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983898 ↗
• InjuryMay 31, 2024Failure to Advance; Failure to Advance

  N/A

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19435430 ↗
• MalfunctionAug 25, 2023Leak/Splash; Leak/Splash

  A FACILITY REPORTED THAT THE CUSA EXCEL 36KHZ TUBING SET (C3601) TUBING WAS FOUND WITH LEAKAGE DURING SETUP. A NEW TUBING WAS OPENED AND WORKED SMOOTH. NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17624228 ↗
• MalfunctionDec 13, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A FACILITY REPORTED THAT AFTER SETTING UP THE CUSA EXCEL 36KHZ TUBING SET (C3601), WATER LEAK OCCURRED PRIOR TO AN OPEN LIVER RESECTION. A NEW UNIT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY AND NO SURGERY DELAY WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15971888 ↗
• MalfunctionNov 4, 2022Leak/Splash; Leak/Splash

  A FACILITY REPORTED THAT THE CUSA EXCEL 36KHZ TUBING SET (C3601) WAS USED IN A TUMORECTOMY PROCEDURE, AND WHEN THE TUBE WAS ATTACHED TO THE MAIN UNIT AND PRIMED, WATER LEAKAGE OCCURRED NEAR THE IRRIGATION PUMP BEFORE THE PROCEDURE. TWO CRACKS WERE CONFIRMED IN THE PRODUCT. THEREFORE, ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. NO SURGICAL DELAY AND ADVERSE CONSEQUENCES TO THE PATIENT WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15728723 ↗
• MalfunctionFeb 25, 2022Output Problem; Output Problem

  THIS IS 4 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 3006697299-2022-00021, 3006697299-2022-00022, AND 3006697299-2022-00023. A FACILITY REPORTED THAT THE AMPLITUDE COULD NOT GO UP DURING FRAGMENTATION. THEY CHANGED TO A NEW TIP AND CONSUMABLES. CUSA EXCEL 36KHZ TUBING SET (C3601) DEVICE WAS INVOLVED, AND SURGICAL DELAY OF 30-40 MINUTES WAS REPORTED. THERE WAS NO ADVERSE PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13599644 ↗