CUSA® Clarity C7404LSRecalls & reported problems
Integra Lifesciences (Ireland) Limited · CUSA® Clarity Extended Laparoscopic Tip, 23kHz · Class U
All models of CUSA Clarity (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780533894), received between Nov 15, 2024 and Nov 15, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Prime” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Failure to Prime1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 15, 2024Failure to Prime; Failure to Prime
A FACILITY REPORTED THAT DURING A SURGICAL PROCEDURE THE FLUID WOULD NOT PRIME ALL THE WAY THROUGH TO THE CUSA CLARITY 23 KHZ EXTENDED LENGTH LAPAROSCOPIC TIP (C7404LS), CAUSING PRESSURE TO BUILD UP AND THE PUMP TO MAKE A RATCHETING NOISE. ADDITIONAL INFORMATION WAS REPORTED AS FOLLOWS: 1. WAS THERE A DELAY IN SURGERY DUE TO PRODUCT PROBLEM? IF YES, HOW LONG? THIS CAUSES A DELAY TO THE SURGERY. I WAS ONLY PRESENT FOR THE FIRST PORTION OF THE DELAY WHICH WAS 45 MINUTES. I'M NOT SURE HOW MUCH LONGER THE DELAY WAS ONCE I LEFT. 2. PLEASE ADVISE WHAT THE TOTAL AMOUNT OF SURGICAL DELAY FOR THIS CASE WAS IN MINUTES/HOURS. I DON¿T KNOW AND WAS NOT ABLE TO GET ADDITIONAL ANSWERS FROM THE HOSPITAL. 3. WAS THE PATIENT UNDER ANESTHESIA WHEN THE MALFUNCTION OCCURRED? YES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20698360 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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