Halyard 34164Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 20680651341642), received between May 30, 2018 and Apr 25, 2025 — classified as 7 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Discolored” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2025Material Integrity Problem; Material Integrity Problem

  THE CUSTOMER REPORTED RUST STAINING ON WRAP WHERE THE TRAY WAS SITTING. ADDITIONAL INFORMATION REPORTED ON APRIL 15, 2025, STATES, THERE WERE A COUPLE OF PROCEDURE CANCELLATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911174 ↗
• MalfunctionApr 25, 2025Material Integrity Problem; Material Integrity Problem

  THE CUSTOMER REPORTED RUST STAINING ON WRAP WHERE THE TRAY WAS SITTING. ADDITIONAL INFORMATION REPORTED ON (B)(6) 2025 STATES, THERE WERE A COUPLE OF PATIENT PROCEDURE CANCELLATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911169 ↗
• InjuryJun 28, 2024Material Discolored; Material Discolored

  INCIDENT SIX. STERILIZATION WRAP EXHIBITED STAINING. FACILITY HAS USED PRODUCT FOR SEVERAL YEARS. THE FACILITY HAS NOT CHANGED THEIR STERILIZATION PROCESS OR PARAMETERS. TRAYS WERE REJECTED BY THE OR AND SIX SURGICAL CASES WERE CANCELLED. ADDITIONALLY, SEVERAL CASES WERE DELAYED UP TO 2-3 HOURS. NO INSTRUMENTS FROM THE TRAYS WERE USED ON PATIENTS. IN TWO SURGICAL CASES, 2 PATIENTS RECEIVED A BLOCK PRIOR TO THE SURGERY BEING CANCELLED. THE PATIENTS WERE PARALYZED FOR SIX HOURS FROM THE WAIST DOWN UNTIL THE MEDICATION WORE OFF. THE CASES WERE RE-SCHEDULED. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED FOR THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19635022 ↗
• InjuryJun 28, 2024Material Discolored; Material Discolored

  INCIDENT THREE: STERILIZATION WRAP EXHIBITED STAINING. FACILITY HAS USED PRODUCT FOR SEVERAL YEARS. THE FACILITY HAS NOT CHANGED THEIR STERILIZATION PROCESS OR PARAMETERS. TRAYS WERE REJECTED BY THE OR AND SIX SURGICAL CASES WERE CANCELLED. ADDITIONALLY, SEVERAL CASES WERE DELAYED UP TO 2-3 HOURS. NO INSTRUMENTS FROM THE TRAYS WERE USED ON PATIENTS. IN TWO SURGICAL CASES, 2 PATIENTS RECEIVED A BLOCK PRIOR TO THE SURGERY BEING CANCELLED. THE PATIENTS WERE PARALYZED FOR SIX HOURS FROM THE WAIST DOWN UNTIL THE MEDICATION WORE OFF. THE CASES WERE RE-SCHEDULED. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED FOR THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19634470 ↗
• InjuryJun 28, 2024Material Discolored; Material Discolored

  INCIDENT TWO: STERILIZATION WRAP EXHIBITED STAINING. FACILITY HAS USED PRODUCT FOR SEVERAL YEARS. THE FACILITY HAS NOT CHANGED THEIR STERILIZATION PROCESS OR PARAMETERS. TRAYS WERE REJECTED BY THE OR AND SIX SURGICAL CASES WERE CANCELLED. ADDITIONALLY, SEVERAL CASES WERE DELAYED UP TO 2-3 HOURS. NO INSTRUMENTS FROM THE TRAYS WERE USED ON PATIENTS. IN TWO SURGICAL CASES, 2 PATIENTS RECEIVED A BLOCK PRIOR TO THE SURGERY BEING CANCELLED. THE PATIENTS WERE PARALYZED FOR SIX HOURS FROM THE WAIST DOWN UNTIL THE MEDICATION WORE OFF. THE CASES WERE RE-SCHEDULED. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED FOR THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19634457 ↗
• InjuryJun 28, 2024Material Discolored; Material Discolored

  INCIDENT FIVE. STERILIZATION WRAP EXHIBITED STAINING. FACILITY HAS USED PRODUCT FOR SEVERAL YEARS. THE FACILITY HAS NOT CHANGED THEIR STERILIZATION PROCESS OR PARAMETERS. TRAYS WERE REJECTED BY THE OR AND SIX SURGICAL CASES WERE CANCELLED. ADDITIONALLY, SEVERAL CASES WERE DELAYED UP TO 2-3 HOURS. NO INSTRUMENTS FROM THE TRAYS WERE USED ON PATIENTS. IN TWO SURGICAL CASES, 2 PATIENTS RECEIVED A BLOCK PRIOR TO THE SURGERY BEING CANCELLED. THE PATIENTS WERE PARALYZED FOR SIX HOURS FROM THE WAIST DOWN UNTIL THE MEDICATION WORE OFF. THE CASES WERE RE-SCHEDULED. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED FOR THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19634190 ↗
• InjuryJun 28, 2024Material Discolored; Material Discolored

  INCIDENT FOUR. STERILIZATION WRAP EXHIBITED STAINING. FACILITY HAS USED PRODUCT FOR SEVERAL YEARS. THE FACILITY HAS NOT CHANGED THEIR STERILIZATION PROCESS OR PARAMETERS. TRAYS WERE REJECTED BY THE OR AND SIX SURGICAL CASES WERE CANCELLED. ADDITIONALLY, SEVERAL CASES WERE DELAYED UP TO 2-3 HOURS. NO INSTRUMENTS FROM THE TRAYS WERE USED ON PATIENTS. IN TWO SURGICAL CASES, 2 PATIENTS RECEIVED A BLOCK PRIOR TO THE SURGERY BEING CANCELLED. THE PATIENTS WERE PARALYZED FOR SIX HOURS FROM THE WAIST DOWN UNTIL THE MEDICATION WORE OFF. THE CASES WERE RE-SCHEDULED. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED FOR THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19634149 ↗
• InjuryJun 28, 2024Material Discolored; Material Discolored

  INCIDENT ONE. STERILIZATION WRAP EXHIBITED STAINING. FACILITY HAS USED PRODUCT FOR SEVERAL YEARS. THE FACILITY HAS NOT CHANGED THEIR STERILIZATION PROCESS OR PARAMETERS. TRAYS WERE REJECTED BY THE OR AND SIX SURGICAL CASES WERE CANCELLED. ADDITIONALLY, SEVERAL CASES WERE DELAYED UP TO 2-3 HOURS. NO INSTRUMENTS FROM THE TRAYS WERE USED ON PATIENTS. IN TWO SURGICAL CASES, 2 PATIENTS RECEIVED A BLOCK PRIOR TO THE SURGERY BEING CANCELLED. THE PATIENTS WERE PARALYZED FOR SIX HOURS FROM THE WAIST DOWN UNTIL THE MEDICATION WORE OFF. THE CASES WERE RE-SCHEDULED. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED FOR THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19634039 ↗
• InjurySep 14, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  THE FACILITY HAS EXPERIENCED HOLES IN THE WRAP POST STERILIZATION. THEY ARE USING CORNER PROTECTORS, AND THE HOLES ARE OCCURRING ON THE MIDDLE AND SIDES OF THE WRAPS ON THE WHITE SIDE. THE CUSTOMER CONFIRMED THE WEIGHT OF THE TRAYS ARE 17-25 POUNDS AND THEY ARE USING THE WRAPS ACCORDING TO THE INSTRUCTIONS FOR USE. THE CUSTOMER STATED THEY EXPERIENCED A DELAY IN A PROCEDURE THAT LAST LESS THAN A HALF HOUR. IT WAS RESOLVED BY TAKING A TRAY FROM ANOTHER CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17749067 ↗
• MalfunctionMay 23, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INCIDENT ONE. CUSTOMER REPORTED THEY HAVE EXPERIENCED WET PACKS. THIS RESULTED IN PATIENT DELAY IN PROCEDURE. ADDITIONAL INCIDENT DETAILS HAVE BEEN REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16989423 ↗
• MalfunctionMay 30, 2018Hole In Material; Hole In Material

  IT WAS REPORTED BY THE CUSTOMER THAT A HOLE WAS DISCOVERED IN A STERILIZATION WRAP POST OR USE. ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2018 FROM CUSTOMER THAT STATES, "THERE WAS NO PATIENT HARM AND THE HOLE WAS SEEN BEFORE PATIENT CARE STARTED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7553837 ↗