Halyard 34145Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20680651341451), received between Sep 21, 2018 and Jan 30, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2026Appropriate Device Problem Term/Code Not Available

  WRAPPING SHEETS EXHIBITED MICRO-PERFORATIONS AFTER STERILIZATION AND WERE ALREADY DAMAGED UPON REMOVAL FROM THE PACKAGE PRIOR TO USE. AS A RESULT, MULTIPLE SURGICAL PROCEDURES WERE DELAYED AFTER PATIENTS WERE ALREADY POSITIONED ON THE OPERATING TABLE. ADDITIONAL DETAILS (INCLUDING PATIENT DETAILS FOR THOSE AFFECTED) HAVE BEEN REQUESTED; HOWEVER, NO FURTHER DETAILS HAVE BEEN PROVIDED TO-DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222485 ↗
• InjuryJul 1, 2024Material Puncture/Hole; Material Puncture/Hole

  HOLES WERE FOUND ON THE STERILIZATION WRAP WHICH CAUSED A DELAY IN PROCEDURE. THE PROCEDURE WAS POSTPONED TO LATER IN THE DAY. THERE WERE NO HOLES OBSERVED BEFORE OR AFTER WRAPPING. THE TRAYS HAD BEEN STORED FOR A WEEK AND WERE PLACED AND STORED CORRECTLY ACCORDING TO CUSTOMER. THEY WERE ALSO OBSERVED TO HAVE NO HOLES OR DEFECTS BEFORE SENDING THEM TO THEATRE FOR THE SCHEDULED OPERATION. THE PATIENT HAD NOT BEEN SEDATED AT THE TIME OF DISCOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19646210 ↗
• InjuryMay 29, 2024Material Puncture/Hole; Material Puncture/Hole

  THERE WERE HOLES IN THE WRAP NOTED AFTER STERILIZATION. SURGICAL PROCEDURE WAS CANCELLED. THIS WAS A PODIATRY PROCEDURE. THE CUSTOMER STATED THAT BOTH THE INITIAL TRAY FOR USE IN THE PROCEDURE AND THE BACKUP TRAY EXHIBITED HOLES. THE ISSUE WAS NOTICED PRIOR TO USE WITH THE PATIENT; HOWEVER, THE PROCEDURE WAS DELAYED AND CANCELLED FOR THE DAY. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY TO COMPLETE THE PROCEDURE. THE HOSPITAL INCURRED THE COST OF THE PROCEDURE. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19415677 ↗
• InjuryApr 11, 2024Material Puncture/Hole; Material Puncture/Hole

  HIP REPLACEMENT PROCEDURE WAS SCHEDULED FOR PATIENT ON (B)(6) 2024. CLINICIAN WAS UNABLE TO PERFORM PROCEDURE AT SCHEDULED TIME BECAUSE HOLES WERE FOUND IN THE STERILIZATION WRAP COVERING SURGICAL TRAY. PATIENT WAS NOT IMPACTED OTHER THAN ANNOYED BY HAVING TO RESCHEDULE PROCEDURE. THE PATIENT WAS NOT SEDATED AT THE TIME OF DISCOVERY. THE COMPLAINT SITE INDICATED THE HOLES WERE NOT NOTED PRIOR TO WRAPPING INSTRUMENT TRAY IN CSSD. THE TRAYS HAD BEEN STORED BY THEM FOR A WEEK PRIOR TO CASE. O&M SALES REP IS CONDUCTING TRAINING WITH THE SITE ON BEST PRACTICES FOR MANAGING STERILIZATION TRAYS TO MINIMIZE RISK OF CAUSING HOLES IN WRAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094107 ↗
• MalfunctionSep 21, 2018Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED ON 25-SEPT-2018 THAT THE SAMPLE WAS NOT AVAILABLE FOR RETURN. IT WAS REPORTED THAT THERE WERE HOLES FOND ON THE WHITE SIDE OF THE STERILIZATION WRAP. THE HOLES WERE DETECTED AFTER USE. ADDITIONAL INFORMATION WAS REPORTED ON 30-AUG-2018 THAT STATES, "THE OBJECTS WHICH WRAPPED WITH THE PRODUCT IN QUESTION AND STERILIZED WERE USED TO THE PATIENT BUT NO PATIENT INJURY REPORTED"

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7897689 ↗