STERRAD VELOCITY™ 43210-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705037049400), received between Feb 21, 2020 and Feb 27, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 18, 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.

• MalfunctionFeb 27, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A SUSPECTED POSITIVE RESULT WITH A STERRAD VELOCITY¿ BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD NX CYCLE. THE CUSTOMER INITIALLY REPORTED THAT THEY RERAN TWICE WITH NEW BIS, AND THE RESULTS WERE NEGATIVE. HOWEVER, ADDITIONAL EVENT INFORMATION RECEIVED ON 04-FEB-2024 SUGGESTS THE AFFECTED LOAD MAY NOT HAVE BEEN REPROCESSED PRIOR TO RELEASE FOR USE ON PATIENTS. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENTS ASSOCIATED WITH THIS EVENT. ALTHOUGH NO HARM OR INJURY HAS BEEN REPORTED, AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS ADVERSE EVENTS, ASP HAS DECIDED TO REPORT ALL INCIDENTS OF SUSPECTED POSITIVE STERRAD VELOCITY¿ BI WHEN THE INVOLVED LOAD IS RELEASED AND USED PRIOR TO REPROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18793148 ↗
• MalfunctionJun 22, 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® CYCLE. THE LOAD WAS RELEASED AND USED ON A PATIENT BEFORE THE BI RESULT WAS DETERMINED. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS EVENT. 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, ASP HAS DECIDED TO REPORT ALL INCIDENTS OF SUSPECTED POSITIVE STERRAD VELOCITY¿ BI WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14778190 ↗
• MalfunctionNov 18, 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. THE LOAD WAS RELEASED FOR USE BEFORE THE BI RESULT WAS DETERMINED. 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 12836900 ↗
• MalfunctionApr 16, 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. THE CUSTOMER STATED THEY PLACED TWO BIS INTO THE STERRAD STERILIZER AND ONE BI WAS NEGATIVE AND THE OTHER BI WAS POSITIVE AFTER A COMPLETED CYCLE. THE AFFECTED LOAD INCLUDED A DAVINCI SCOPE THAT 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: Insufficient Information

  MAUDE report 11681737 ↗
• MalfunctionApr 7, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A SUSPECT POSITIVE RESULT WITH A STERRAD VELOCITY¿ BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® CYCLE. THEY STATED TWO BIS WERE USED AND ONE BI NEGATIVE AND ONE BI WAS POSITIVE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11629672 ↗
• MalfunctionJan 25, 2021Device Reprocessing Problem; Contamination /Decontamination Problem

  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 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 11227566 ↗
• MalfunctionFeb 21, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A VELOCITY¿ BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100NX CYCLE. THE BI WAS INCUBATED FOR 30 MINUTES. THE BI WAS PROCESSED ON THE BOTTOM SHELF CLOSE TO THE REAR OF THE CHAMBER, AND THE BI WAS NOT PLACED IN THE POUCH WITH THE LOAD OR SECURED TO THE LOAD USING TAPE. THE RESULT OF THE PREVIOUS AND SUBSEQUENT TWO BIS WERE NEGATIVE. NO TAPE/LABELING WAS PLACED OVER THE CAP HOLES PRIOR TO PROCESSING, THE CAP WAS DEPRESSED AFTER PROCESSING, THE BI WAS CRUSHED AFTER PROCESSING, NO REDUCTION IN MEDIA/LEAKAGE WAS OBSERVED, AND THERE WERE NO PUNCTURES ON THE SIDE OF THE PLASTIC OR MEDIA LEAK. THE AFFECTED LOAD WAS INITIALLY REPORTED AS BEING REPROCESSED AND NOT USED ON A PATIENT. HOWEVER; UPON FURTHER FOLLOW-UP, THE CUSTOMER REPORTED THAT ONE BRONCHOSCOPE WAS RELEASED AND USED ON A PATIENT PRIOR TO REPROCESSING THE LOAD. 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 MATTE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9741741 ↗