Halyard 44195Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10680651441956), received between Mar 29, 2019 and May 1, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2019Peeled/Delaminated; Peeled/Delaminated

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SAME UNIT, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2019-00046 FOR THE SECOND EVENT. IT WAS REPORTED THAT DURING A KNEE PROCEDURE, DEPTH MARKERS WERE REMOVED FROM THREE INTRODUCERS PLACED IN THE KNEE. DURING FIRST ABLATION AT ANTERIOR FEMORAL SITE, MACHINE KEPT SIGNALING HIGH IMPEDANCE AND THE CLINICIANS WERE UNABLE TO COMPLETE THE PROCEDURE. THE TWO OTHER PROCEDURE SITES WERE DONE WITHOUT INCIDENT. THE CLINICIANS RETURNED TO THE FIRST SITE AND ATTEMPTED THE ABLATION ONCE AGAIN. THE PAIN MANAGEMENT GENERATOR CONTINUED TO INDICATE WARNING MESSAGE OF HIGH IMPEDANCE. THE INTRODUCER WAS PULLED BACK SLIGHTLY AND ABLATION WAS ABLE TO BE COMPLETED. WHEN INTRODUCER WAS REMOVED, IT WAS NOTICED THAT THE POLYIMIDE COATING STAYED IN THE PATIENT. THE PHYSICIAN WAS ABLE TO REMOVE IT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8568999 ↗
• MalfunctionApr 29, 2019Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SAME UNIT, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2019-00045 FOR THE FIRST EVENT. IT WAS REPORTED THAT DURING A KNEE PROCEDURE, DEPTH MARKERS WERE REMOVED FROM THREE INTRODUCERS PLACED IN THE KNEE. DURING FIRST ABLATION AT ANTERIOR FEMORAL SITE, MACHINE KEPT SIGNALING HIGH IMPEDANCE AND THE CLINICIANS WERE UNABLE TO COMPLETE THE PROCEDURE. THE TWO OTHER PROCEDURE SITES WERE DONE WITHOUT INCIDENT. THE CLINICIANS RETURNED TO THE FIRST SITE AND ATTEMPTED THE ABLATION ONCE AGAIN. THE PAIN MANAGEMENT GENERATOR CONTINUED TO INDICATE WARNING MESSAGE OF HIGH IMPEDANCE. THE INTRODUCER WAS PULLED BACK SLIGHTLY AND ABLATION WAS ABLE TO BE COMPLETED. THE PHYSICIAN NOTICED THAT THE TIP OF THE INTRODUCER DID NOT COME OUT. IT WAS BELIEVED THAT 1/2CM TO 1CM OF INTRODUCER WAS RETAINED DEEP IN ABLATION SITE. BECAUSE THE PATIENT IS ON BLOOD THINNERS, THE DOCTOR OPTED TO LEAVE THE RETAINED PIECE IN THE PATIENT AND NOT PURSUE REMOVAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 8563144 ↗
• MalfunctionMar 29, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE CERVICAL RADIO FREQUENCY ABLATION (RFA) PROCEDURE IT WAS NOTED THAT UPON REMOVING THE PROBE FROM THE PATIENT, THE POLYIMIDE COATING WAS NOTED TO BE LOOSENED AND RETRACTED AT THE DISTAL END. THE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8467171 ↗