STERRAD VELOCITY™ 43210Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705037048908), received between Jun 14, 2018 and May 4, 2022 — classified as 10 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A STERRAD VELOCITY¿ BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® NX CYCLE. 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 WAS 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 STERRAD VELOCITY¿ BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14274417 ↗
• MalfunctionNov 7, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A STERRAD VELOCITY¿ BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® CYCLE. IT WAS INITIALLY REPORTED THAT NO LOAD WAS INVOLVED. ON (B)(6) 2021, ADVANCED STERILIZATION PRODUCTS (ASP) RECEIVED ADDITIONAL INFORMATION THAT THE 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 STERRAD VELOCITY¿ BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12756329 ↗
• MalfunctionJul 9, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A STERRAD VELOCITY" BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD¿ NX CYCLE. IT WAS INITIALLY REPORTED THAT THE AFFECTED LOAD, WHICH INCLUDED A CYSTOSCOPE, WAS REPROCESSED. ON (B)(6) 2021, ADVANCED STERILIZATION PRODUCTS (ASP) RECEIVED ADDITIONAL INFORMATION THAT THE 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 STERRAD VELOCITY" BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12145720 ↗
• MalfunctionOct 29, 2020Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A STERRAD VELOCITY¿ BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® NX CYCLE. THE AFFECTED LOAD, WHICH INCLUDED A CAMERA, 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 STERRAD VELOCITY¿ BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10755852 ↗
• MalfunctionSep 30, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A STERRAD VELOCITY¿ BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® CYCLE. 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 STERRAD VELOCITY¿ 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 9136917 ↗
• MalfunctionAug 27, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A STERRAD VELOCITY¿ BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100NX DUO-CYCLE. 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 STERRAD VELOCITY¿ 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 8937509 ↗
• MalfunctionJul 23, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  UPON FOLLOW-UP FOR ANOTHER ISSUE, A CUSTOMER REPORTED A POSITIVE RESULT WITH A STERRAD® VELOCITY¿ BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® CYCLE. THE UNRELATED ISSUE OCCURRED ON THREE SEPARATE EVENT DATES: (B)(6) 2019 AND THE CUSTOMER DOES NOT KNOW WHICH OF THE THREE EVENT DATES THE SUSPECT POSITIVE BI OCCURRED. THE CHEMICAL INDICATOR (CI) CHANGED COLOR CORRECTLY. THE PREVIOUS AND SUBSEQUENT BI RESULTS WERE BOTH NEGATIVE. HOWEVER; THE BI WAS REPORTED TO HAVE MEDIA EVAPORATION IN THE VIAL AFTER STERILIZATION. THE AFFECTED LOAD WAS RECALLED EXCEPT ONE ITEM 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 VELOCITY¿ BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8817757 ↗
• MalfunctionSep 12, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A STERRAD® VELOCITY¿ BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® CYCLE. 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 STERRAD® VELOCITY¿ BIOLOGICAL INDICATORS WHEN THE LOADS HAVE BEEN RELEASED FOR USE PRIOR TO REPROCESSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7871260 ↗
• MalfunctionSep 12, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A STERRAD® VELOCITY¿ BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® CYCLE. THE BI WAS INCUBATED FOR 30 MINUTES. 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 STERRAD® VELOCITY¿ BIOLOGICAL INDICATORS WHEN THE LOADS HAVE BEEN RELEASED FOR USE PRIOR TO REPROCESSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7869172 ↗
• MalfunctionJun 14, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A STERRAD® VELOCITY¿ BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100S CYCLE. 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 STERRAD® VELOCITY¿ BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED PRIOR TO REPROCESSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7601176 ↗