PINNACLE® 2112431Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04046964201141), received between Mar 20, 2025 and Mar 27, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: PARTICULATES FOUND IN FINAL PRODUCT. WE HAVE BEEN NOTICING THE OCCURRENCE OF PARTICULATE MATTER BEING FOUND AT AQL INSPECTIONS AT OUR CAPS LHV FACILITY AND HAD INQUIRED ABOUT THE AVAILABILITY OF A FILTER TO USE FOR APEX COMPOUNDING. WE WERE INFORMED THAT A FILTER FOR APEX IS NOT AVAILABLE AT THIS TIME. WOULD YOU BE ABLE TO PROVIDE US WITH AN OFFICIAL ASSESSMENT THAT EVALUATES THE POSSIBILITY OF USING A FILTER OR SOME KIND OF DOCUMENTATION AS TO WHY THE USE OF A FILTER IS NOT FEASIBLE AT THIS TIME? THE PARTICLES ARE FOUND INSIDE THE FINISHED FINAL PRODUCT. RECENTLY, SOME OF THE PARTICLES THAT HAVE BEEN SENT FOR IDENTIFICATION TESTING HAVE BEEN IDENTIFIED AS A SYNTHETIC LATEX RUBBER FROM THE DRUG VIAL RUBBER STOPPERS. THIS WOULD INDICATE THE POTENTIAL FOR CORING OF THE RUBBER STOPPERS WHEN THE TECHNICIAN INSERTS THE MINI-SPIKE INTO THE VIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21706439 ↗
• MalfunctionMar 27, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION PARTICULATES FOUND IN FINAL PRODUCT. WE HAVE BEEN NOTICING THE OCCURRENCE OF PARTICULATE MATTER BEING FOUND AT AQL INSPECTIONS AT OUR CAPS LHV FACILITY AND HAD INQUIRED ABOUT THE AVAILABILITY OF A FILTER TO USE FOR APEX COMPOUNDING. WE WERE INFORMED THAT A FILTER FOR APEX IS NOT AVAILABLE AT THIS TIME. WOULD YOU BE ABLE TO PROVIDE US WITH AN OFFICIAL ASSESSMENT THAT EVALUATES THE POSSIBILITY OF USING A FILTER OR SOME KIND OF DOCUMENTATION AS TO WHY THE USE OF A FILTER IS NOT FEASIBLE AT THIS TIME? THE PARTICLES ARE FOUND INSIDE THE FINISHED FINAL PRODUCT. RECENTLY, SOME OF THE PARTICLES THAT HAVE BEEN SENT FOR IDENTIFICATION TESTING HAVE BEEN IDENTIFIED AS A SYNTHETIC LATEX RUBBER FROM THE DRUG VIAL RUBBER STOPPERS. THIS WOULD INDICATE THE POTENTIAL FOR CORING OF THE RUBBER STOPPERS WHEN THE TECHNICIAN INSERTS THE MINI-SPIKE INTO THE VIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21706293 ↗
• MalfunctionMar 20, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: PARTICULATES FOUND IN FINAL PRODUCT. WE HAVE BEEN NOTICING THE OCCURRENCE OF PARTICULATE MATTER BEING FOUND AT AQL INSPECTIONS AT OUR CAPS LHV FACILITY AND HAD INQUIRED ABOUT THE AVAILABILITY OF A FILTER TO USE FOR APEX COMPOUNDING. WE WERE INFORMED THAT A FILTER FOR APEX IS NOT AVAILABLE AT THIS TIME. WOULD YOU BE ABLE TO PROVIDE US WITH AN OFFICIAL ASSESSMENT THAT EVALUATES THE POSSIBILITY OF USING A FILTER OR SOME KIND OF DOCUMENTATION AS TO WHY THE USE OF A FILTER IS NOT FEASIBLE AT THIS TIME? THE PARTICLES ARE FOUND INSIDE THE FINISHED FINAL PRODUCT. RECENTLY, SOME OF THE PARTICLES THAT HAVE BEEN SENT FOR IDENTIFICATION TESTING HAVE BEEN IDENTIFIED AS A SYNTHETIC LATEX RUBBER FROM THE DRUG VIAL RUBBER STOPPERS. THIS WOULD INDICATE THE POTENTIAL FOR CORING OF THE RUBBER STOPPERS WHEN THE TECHNICIAN INSERTS THE MINI-SPIKE INTO THE VIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651218 ↗
• MalfunctionMar 20, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: PARTICULATES FOUND IN FINAL PRODUCT. WE HAVE BEEN NOTICING THE OCCURRENCE OF PARTICULATE MATTER BEING FOUND AT AQL INSPECTIONS AT OUR CAPS LHV FACILITY AND HAD INQUIRED ABOUT THE AVAILABILITY OF A FILTER TO USE FOR APEX COMPOUNDING. WE WERE INFORMED THAT A FILTER FOR APEX IS NOT AVAILABLE AT THIS TIME. WOULD YOU BE ABLE TO PROVIDE US WITH AN OFFICIAL ASSESSMENT THAT EVALUATES THE POSSIBILITY OF USING A FILTER OR SOME KIND OF DOCUMENTATION AS TO WHY THE USE OF A FILTER IS NOT FEASIBLE AT THIS TIME? THE PARTICLES ARE FOUND INSIDE THE FINISHED FINAL PRODUCT. RECENTLY, SOME OF THE PARTICLES THAT HAVE BEEN SENT FOR IDENTIFICATION TESTING HAVE BEEN IDENTIFIED AS A SYNTHETIC LATEX RUBBER FROM THE DRUG VIAL RUBBER STOPPERS. THIS WOULD INDICATE THE POTENTIAL FOR CORING OF THE RUBBER STOPPERS WHEN THE TECHNICIAN INSERTS THE MINI-SPIKE INTO THE VIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651200 ↗
• MalfunctionMar 20, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPROTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION PARTICULATES FOUND IN FINAL PRODUCT. WE HAVE BEEN NOTICING THE OCCURRENCE OF PARTICULATE MATTER BEING FOUND AT AQL INSPECTIONS AT OUR CAPS LHV FACILITY AND HAD INQUIRED ABOUT THE AVAILABILITY OF A FILTER TO USE FOR APEX COMPOUNDING. WE WERE INFORMED THAT A FILTER FOR APEX IS NOT AVAILABLE AT THIS TIME. WOULD YOU BE ABLE TO PROVIDE US WITH AN OFFICIAL ASSESSMENT THAT EVALUATES THE POSSIBILITY OF USING A FILTER OR SOME KIND OF DOCUMENTATION AS TO WHY THE USE OF A FILTER IS NOT FEASIBLE AT THIS TIME? THE PARTICLES ARE FOUND INSIDE THE FINISHED FINAL PRODUCT. RECENTLY, SOME OF THE PARTICLES THAT HAVE BEEN SENT FOR IDENTIFICATION TESTING HAVE BEEN IDENTIFIED AS A SYNTHETIC LATEX RUBBER FROM THE DRUG VIAL RUBBER STOPPERS. THIS WOULD INDICATE THE POTENTIAL FOR CORING OF THE RUBBER STOPPERS WHEN THE TECHNICIAN INSERTS THE MINI-SPIKE INTO THE VIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651172 ↗
• MalfunctionMar 20, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: PARTICULATES FOUND IN FINAL PRODUCT. WE HAVE BEEN NOTICING THE OCCURRENCE OF PARTICULATE MATTER BEING FOUND AT AQL INSPECTIONS AT OUR CAPS LHV FACILITY AND HAD INQUIRED ABOUT THE AVAILABILITY OF A FILTER TO USE FOR APEX COMPOUNDING. WE WERE INFORMED THAT A FILTER FOR APEX IS NOT AVAILABLE AT THIS TIME. WOULD YOU BE ABLE TO PROVIDE US WITH AN OFFICIAL ASSESSMENT THAT EVALUATES THE POSSIBILITY OF USING A FILTER OR SOME KIND OF DOCUMENTATION AS TO WHY THE USE OF A FILTER IS NOT FEASIBLE AT THIS TIME? THE PARTICLES ARE FOUND INSIDE THE FINISHED FINAL PRODUCT. RECENTLY, SOME OF THE PARTICLES THAT HAVE BEEN SENT FOR IDENTIFICATION TESTING HAVE BEEN IDENTIFIED AS A SYNTHETIC LATEX RUBBER FROM THE DRUG VIAL RUBBER STOPPERS. THIS WOULD INDICATE THE POTENTIAL FOR CORING OF THE RUBBER STOPPERS WHEN THE TECHNICIAN INSERTS THE MINI-SPIKE INTO THE VIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651099 ↗