Cyclesure 14324-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705037048564), received between Jun 14, 2019 and Jun 14, 2019 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100S CYCLE. THE BI WAS INCUBATED FOR 26 HOURS. THE CHEMICAL INDICATOR (CI) CHANGED COLOR CORRECTLY. THE PREVIOUS AND SUBSEQUENT BI RESULTS WERE BOTH NEGATIVE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8702071 ↗