Halyard 29980Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20680651299806), received between Apr 16, 2021 and Apr 7, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Fitting Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2023Pressure Problem; Pressure Problem

  PATIENT # TWO. IT WAS INITIALLY REPORTED BY COMPLAINANT THAT THERE WAS A PRESSURE INJURY THAT OCCURRED IN THE ICU IN (B)(6) AS A RESULT OF ARTERIAL STABILIZATION DEVICE. COMPLAINANT PROVIDED ADDITIONAL INFORMATION STATING THERE WERE TWO INCIDENTS. EVENT DATES WERE: (B)(6) 2023 AND THE NUMBER OF PATIENTS WERE TWO. PATIENT 2: THE PATIENT HAS BEEN DISCHARGED. THE DEVICE WAS REMOVED AND/OR WAS REPLACED WITH DIFFERENT FOAM ARTERIAL DEVICE. THE LOCATION OF THE INJURY WAS THE LEFT HAND INNER PALM. THE TYPE OF INJURY WAS A DEEP TISSUE PRESSURE WOUND. THE PROCEDURE AN ARTERIAL LINE STABILIZATION APPLIED IN THE EMERGENCY ROOM (ER). THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT WITH THE DEVICE IN PLACE FROM ER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16700950 ↗
• InjuryApr 6, 2023Pressure Problem; Pressure Problem

  PATIENT # ONE. IT WAS INITIALLY REPORTED BY COMPLAINANT THAT THERE WAS A PRESSURE INJURY THAT OCCURRED IN THE ICU IN JANUARY AS A RESULT OF ARTERIAL STABILIZATION DEVICE. COMPLAINANT PROVIDED ADDITIONAL INFORMATION STATING THERE WERE TWO INCIDENTS. EVENT DATES WERE: (B)(6) 2023 AND (B)(6) 2023 AND THE NUMBER OF PATIENTS WERE TWO. PATIENT 1: THE PATIENT HAS BEEN DISCHARGED. THE DEVICE WAS REMOVED AND/OR WAS REPLACED WITH DIFFERENT FOAM ARTERIAL DEVICE. THE LOCATION OF THE INJURY WAS THE LEFT HAND INNER PALM. THE TYPE OF INJURY WAS A DEEP TISSUE PRESSURE WOUND. THE PROCEDURE AN ARTERIAL LINE STABILIZATION APPLIED IN THE EMERGENCY ROOM (ER). THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT WITH THE DEVICE IN PLACE FROM ER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16694604 ↗
• InjuryApr 16, 2021Fitting Problem; Fitting Problem

  O&M HALYARD, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3014421917-2021-00001 FOR THE FIRST PATIENT. IT WAS REPORTED BY THE CUSTOMER WHO STATED, WE ARE REACHING OUT TO YOU TO INFORM YOU OF AN ISSUE WE ARE HAVING USING YOUR ARTERIAL WRIST SUPPORT. WE HAVE HAD ISSUES WITH THEM CAUSING PRESSURE SORES BETWEEN THE THUMB AND FORE FINGER. ADDITIONAL INFORMATION WAS RECEIVED ON 9-APRIL-2021 THAT STATES, THERE WARE TWO PATIENTS WHO HAVE UNSTAGEABLE PRESSURE INJURIES. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11680326 ↗
• InjuryApr 16, 2021Fitting Problem; Fitting Problem

  O&M HALYARD, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3014421917-2021-00002 FOR THE SECOND PATIENT. IT WAS REPORTED BY THE CUSTOMER WHO STATED, WE ARE REACHING OUT TO YOU TO INFORM YOU OF AN ISSUE WE ARE HAVING USING YOUR ARTERIAL WRIST SUPPORT. WE HAVE HAD ISSUES WITH THEM CAUSING PRESSURE SORES BETWEEN THE THUMB AND FORE FINGER. ADDITIONAL INFORMATION WAS RECEIVED ON 9-APRIL-2021 THAT STATES, THERE WARE TWO PATIENTS WHO HAVE UNSTAGEABLE PRESSURE INJURIES. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11679603 ↗