AnchorFast 9799 (UDI 00610075129386)Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00610075129386), received between Aug 10, 2021 and Jun 23, 2026 — classified as 1 death, 41 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 23, 2024Open, Classified

   Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

   Z-1180-2025 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE FAMILY REMOVED WRIST RESTRAINTS AND PATIENT PULLED TUBE OUT.

  Patient problems: Unintended Extubation

  MAUDE report 25599735 ↗
• InjuryJun 23, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S ENDOTRACHEAL TUBE (ETT) BECAME DISLODGED DURING A COUGHING EPISODE. THE REGISTERED NURSE RESPONDED AND OBSERVED THAT THE ETT AND HOLLISTER'S ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER HAD DETACHED FROM THE PATIENT. THE PATIENT REQUIRED REINTUBATION, NO OTHER DETAILS ARE AVAILABLE AT THIS TIME REGARDING THIS REPORTED EVENT.

  Patient problems: Unintended Extubation

  MAUDE report 25599461 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS 11 OUT OF 17 REPORTS. IT WAS REPORTED THAT THIS FACILITY OBSERVED AN INCREASE IN UNPLANNED ENDOTRACHEAL TUBE EXTUBATIONS WHILE THE ANCHORFAST ENDOTRACHEAL TUBE FASTENER WAS IN USE. IT WAS REPORTED THAT THE FACILITY DID NOT OBSERVE ANY DEVICE MALFUNCTION AND THEY ARE NOT SURE WHY THE UNPLANNED EXTUBATIONS HAPPENED. IT WAS FURTHER REPORTED THAT THERE WERE 17 UNPLANNED EXTUBATIONS THAT OCCURRED BETWEEN JUNE 2025 AND JANUARY 2026. IT WAS REPORTED THROUGH CHART REVIEWS THAT THE PATIENT'S LEVEL OF SEDATION RANGED FROM MILD TO SEDATED, THE ANCHORFAST NECK STRAPS WERE IN USE, UNABLE TO DETERMINE HOW THE VENTILATOR CIRCUITS WERE SUPPORTED, ONLY ONE INCIDENT REPORTED FREQUENT DEVICE CHANGES DUE TO CLAMMY SKIN, BUT OTHERWISE, THEIR PRACTICE IS TO CHANGE THE ANCHORFAST DEVICE EVERY 48 HOURS AND AS NEEDED, AND THAT 2 OF THE 17 PATIENTS WERE BEING TURNED AT THE TIME OF THE UNPLANNED EXTUBATION. HOLLISTER IS WORKING WITH THE ACCOUNT TO PROVIDE TRAINING AND INSERVICING AS NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 24777368 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS 5 OUT OF 17 REPORTS. IT WAS REPORTED THAT THIS FACILITY OBSERVED AN INCREASE IN UNPLANNED ENDOTRACHEAL TUBE EXTUBATIONS WHILE THE ANCHORFAST ENDOTRACHEAL TUBE FASTENER WAS IN USE. IT WAS REPORTED THAT THE FACILITY DID NOT OBSERVE ANY DEVICE MALFUNCTION AND THEY ARE NOT SURE WHY THE UNPLANNED EXTUBATIONS HAPPENED. IT WAS FURTHER REPORTED THAT THERE WERE 17 UNPLANNED EXTUBATIONS THAT OCCURRED BETWEEN (B)(6) 2025 AND (B)(6) 2026. IT WAS REPORTED THROUGH CHART REVIEWS THAT THE PATIENT'S LEVEL OF SEDATION RANGED FROM MILD TO SEDATED, THE ANCHORFAST NECK STRAPS WERE IN USE, UNABLE TO DETERMINE HOW THE VENTILATOR CIRCUITS WERE SUPPORTED, ONLY ONE INCIDENT REPORTED FREQUENT DEVICE CHANGES DUE TO CLAMMY SKIN, BUT OTHERWISE, THEIR PRACTICE IS TO CHANGE THE ANCHORFAST DEVICE EVERY 48 HOURS AND AS NEEDED, AND THAT 2 OF THE 17 PATIENTS WERE BEING TURNED AT THE TIME OF THE UNPLANNED EXTUBATION. HOLLISTER IS WORKING WITH THE ACCOUNT TO PROVIDE TRAINING AND INSERVICING AS NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 24777367 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS 13 OUT OF 17 REPORTS. IT WAS REPORTED THAT THIS FACILITY OBSERVED AN INCREASE IN UNPLANNED ENDOTRACHEAL TUBE EXTUBATIONS WHILE THE ANCHORFAST ENDOTRACHEAL TUBE FASTENER WAS IN USE. IT WAS REPORTED THAT THE FACILITY DID NOT OBSERVE ANY DEVICE MALFUNCTION AND THEY ARE NOT SURE WHY THE UNPLANNED EXTUBATIONS HAPPENED. IT WAS FURTHER REPORTED THAT THERE WERE 17 UNPLANNED EXTUBATIONS THAT OCCURRED BETWEEN JUNE 2025 AND JANUARY 2026. IT WAS REPORTED THROUGH CHART REVIEWS THAT THE PATIENT'S LEVEL OF SEDATION RANGED FROM MILD TO SEDATED, THE ANCHORFAST NECK STRAPS WERE IN USE, UNABLE TO DETERMINE HOW THE VENTILATOR CIRCUITS WERE SUPPORTED, ONLY ONE INCIDENT REPORTED FREQUENT DEVICE CHANGES DUE TO CLAMMY SKIN, BUT OTHERWISE, THEIR PRACTICE IS TO CHANGE THE ANCHORFAST DEVICE EVERY 48 HOURS AND AS NEEDED, AND THAT 2 OF THE 17 PATIENTS WERE BEING TURNED AT THE TIME OF THE UNPLANNED EXTUBATION. HOLLISTER IS WORKING WITH THE ACCOUNT TO PROVIDE TRAINING AND INSERVICING AS NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 24766053 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS 14 OUT OF 17 REPORTS. IT WAS REPORTED THAT THIS FACILITY OBSERVED AN INCREASE IN UNPLANNED ENDOTRACHEAL TUBE EXTUBATIONS WHILE THE ANCHORFAST ENDOTRACHEAL TUBE FASTENER WAS IN USE. IT WAS REPORTED THAT THE FACILITY DID NOT OBSERVE ANY DEVICE MALFUNCTION AND THEY ARE NOT SURE WHY THE UNPLANNED EXTUBATIONS HAPPENED. IT WAS FURTHER REPORTED THAT THERE WERE 17 UNPLANNED EXTUBATIONS THAT OCCURRED BETWEEN (B)(6) 2025 AND (B)(6) 2026. IT WAS REPORTED THROUGH CHART REVIEWS THAT THE PATIENT'S LEVEL OF SEDATION RANGED FROM MILD TO SEDATED, THE ANCHORFAST NECK STRAPS WERE IN USE, UNABLE TO DETERMINE HOW THE VENTILATOR CIRCUITS WERE SUPPORTED, ONLY ONE INCIDENT REPORTED FREQUENT DEVICE CHANGES DUE TO CLAMMY SKIN, BUT OTHERWISE, THEIR PRACTICE IS TO CHANGE THE ANCHORFAST DEVICE EVERY 48 HOURS AND AS NEEDED, AND THAT 2 OF THE 17 PATIENTS WERE BEING TURNED AT THE TIME OF THE UNPLANNED EXTUBATION. HOLLISTER IS WORKING WITH THE ACCOUNT TO PROVIDE TRAINING AND INSERVICING AS NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 24766052 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS 17 OUT OF 17 REPORTS. IT WAS REPORTED THAT THIS FACILITY OBSERVED AN INCREASE IN UNPLANNED ENDOTRACHEAL TUBE EXTUBATIONS WHILE THE ANCHORFAST ENDOTRACHEAL TUBE FASTENER WAS IN USE. IT WAS REPORTED THAT THE FACILITY DID NOT OBSERVE ANY DEVICE MALFUNCTION AND THEY ARE NOT SURE WHY THE UNPLANNED EXTUBATIONS HAPPENED. IT WAS FURTHER REPORTED THAT THERE WERE 17 UNPLANNED EXTUBATIONS THAT OCCURRED BETWEEN (B)(6) 2025 AND (B)(6) 2026. IT WAS REPORTED THROUGH CHART REVIEWS THAT THE PATIENT'S LEVEL OF SEDATION RANGED FROM MILD TO SEDATED, THE ANCHORFAST NECK STRAPS WERE IN USE, UNABLE TO DETERMINE HOW THE VENTILATOR CIRCUITS WERE SUPPORTED, ONLY ONE INCIDENT REPORTED FREQUENT DEVICE CHANGES DUE TO CLAMMY SKIN, BUT OTHERWISE, THEIR PRACTICE IS TO CHANGE THE ANCHORFAST DEVICE EVERY 48 HOURS AND AS NEEDED, AND THAT 2 OF THE 17 PATIENTS WERE BEING TURNED AT THE TIME OF THE UNPLANNED EXTUBATION. HOLLISTER IS WORKING WITH THE ACCOUNT TO PROVIDE TRAINING AND INSERVICING AS NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 24766051 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS 16 OUT OF 17 REPORTS. IT WAS REPORTED THAT THIS FACILITY OBSERVED AN INCREASE IN UNPLANNED ENDOTRACHEAL TUBE EXTUBATIONS WHILE THE ANCHORFAST ENDOTRACHEAL TUBE FASTENER WAS IN USE. IT WAS REPORTED THAT THE FACILITY DID NOT OBSERVE ANY DEVICE MALFUNCTION AND THEY ARE NOT SURE WHY THE UNPLANNED EXTUBATIONS HAPPENED. IT WAS FURTHER REPORTED THAT THERE WERE 17 UNPLANNED EXTUBATIONS THAT OCCURRED BETWEEN JUNE 2025 AND JANUARY 2026. IT WAS REPORTED THROUGH CHART REVIEWS THAT THE PATIENT'S LEVEL OF SEDATION RANGED FROM MILD TO SEDATED, THE ANCHORFAST NECK STRAPS WERE IN USE, UNABLE TO DETERMINE HOW THE VENTILATOR CIRCUITS WERE SUPPORTED, ONLY ONE INCIDENT REPORTED FREQUENT DEVICE CHANGES DUE TO CLAMMY SKIN, BUT OTHERWISE, THEIR PRACTICE IS TO CHANGE THE ANCHORFAST DEVICE EVERY 48 HOURS AND AS NEEDED, AND THAT 2 OF THE 17 PATIENTS WERE BEING TURNED AT THE TIME OF THE UNPLANNED EXTUBATION. HOLLISTER IS WORKING WITH THE ACCOUNT TO PROVIDE TRAINING AND INSERVICING AS NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 24766050 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS 15 OUT OF 17 REPORTS. IT WAS REPORTED THAT THIS FACILITY OBSERVED AN INCREASE IN UNPLANNED ENDOTRACHEAL TUBE EXTUBATIONS WHILE THE ANCHORFAST ENDOTRACHEAL TUBE FASTENER WAS IN USE. IT WAS REPORTED THAT THE FACILITY DID NOT OBSERVE ANY DEVICE MALFUNCTION AND THEY ARE NOT SURE WHY THE UNPLANNED EXTUBATIONS HAPPENED. IT WAS FURTHER REPORTED THAT THERE WERE 17 UNPLANNED EXTUBATIONS THAT OCCURRED BETWEEN (B)(6) 2025 AND (B)(6) 2026. IT WAS REPORTED THROUGH CHART REVIEWS THAT THE PATIENT'S LEVEL OF SEDATION RANGED FROM MILD TO SEDATED, THE ANCHORFAST NECK STRAPS WERE IN USE, UNABLE TO DETERMINE HOW THE VENTILATOR CIRCUITS WERE SUPPORTED, ONLY ONE INCIDENT REPORTED FREQUENT DEVICE CHANGES DUE TO CLAMMY SKIN, BUT OTHERWISE, THEIR PRACTICE IS TO CHANGE THE ANCHORFAST DEVICE EVERY 48 HOURS AND AS NEEDED, AND THAT 2 OF THE 17 PATIENTS WERE BEING TURNED AT THE TIME OF THE UNPLANNED EXTUBATION. HOLLISTER IS WORKING WITH THE ACCOUNT TO PROVIDE TRAINING AND INSERVICING AS NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 24766049 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS 10 OUT OF 17 REPORTS. IT WAS REPORTED THAT THIS FACILITY OBSERVED AN INCREASE IN UNPLANNED ENDOTRACHEAL TUBE EXTUBATIONS WHILE THE ANCHORFAST ENDOTRACHEAL TUBE FASTENER WAS IN USE. IT WAS REPORTED THAT THE FACILITY DID NOT OBSERVE ANY DEVICE MALFUNCTION AND THEY ARE NOT SURE WHY THE UNPLANNED EXTUBATIONS HAPPENED. IT WAS FURTHER REPORTED THAT THERE WERE 17 UNPLANNED EXTUBATIONS THAT OCCURRED BETWEEN (B)(6) 2025 AND (B)(6) 2026. IT WAS REPORTED THROUGH CHART REVIEWS THAT THE PATIENT'S LEVEL OF SEDATION RANGED FROM MILD TO SEDATED, THE ANCHORFAST NECK STRAPS WERE IN USE, UNABLE TO DETERMINE HOW THE VENTILATOR CIRCUITS WERE SUPPORTED, ONLY ONE INCIDENT REPORTED FREQUENT DEVICE CHANGES DUE TO CLAMMY SKIN, BUT OTHERWISE, THEIR PRACTICE IS TO CHANGE THE ANCHORFAST DEVICE EVERY 48 HOURS AND AS NEEDED, AND THAT 2 OF THE 17 PATIENTS WERE BEING TURNED AT THE TIME OF THE UNPLANNED EXTUBATION. HOLLISTER IS WORKING WITH THE ACCOUNT TO PROVIDE TRAINING AND INSERVICING AS NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 24766046 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS 9 OUT OF 17 REPORTS. IT WAS REPORTED THAT THIS FACILITY OBSERVED AN INCREASE IN UNPLANNED ENDOTRACHEAL TUBE EXTUBATIONS WHILE THE ANCHORFAST ENDOTRACHEAL TUBE FASTENER WAS IN USE. IT WAS REPORTED THAT THE FACILITY DID NOT OBSERVE ANY DEVICE MALFUNCTION AND THEY ARE NOT SURE WHY THE UNPLANNED EXTUBATIONS HAPPENED. IT WAS FURTHER REPORTED THAT THERE WERE 17 UNPLANNED EXTUBATIONS THAT OCCURRED BETWEEN (B)(6) 2025 AND (B)(6) 2026. IT WAS REPORTED THROUGH CHART REVIEWS THAT THE PATIENT'S LEVEL OF SEDATION RANGED FROM MILD TO SEDATED, THE ANCHORFAST NECK STRAPS WERE IN USE, UNABLE TO DETERMINE HOW THE VENTILATOR CIRCUITS WERE SUPPORTED, ONLY ONE INCIDENT REPORTED FREQUENT DEVICE CHANGES DUE TO CLAMMY SKIN, BUT OTHERWISE, THEIR PRACTICE IS TO CHANGE THE ANCHORFAST DEVICE EVERY 48 HOURS AND AS NEEDED, AND THAT 2 OF THE 17 PATIENTS WERE BEING TURNED AT THE TIME OF THE UNPLANNED EXTUBATION. HOLLISTER IS WORKING WITH THE ACCOUNT TO PROVIDE TRAINING AND INSERVICING AS NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 24766045 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS 12 OUT OF 17 REPORTS. IT WAS REPORTED THAT THIS FACILITY OBSERVED AN INCREASE IN UNPLANNED ENDOTRACHEAL TUBE EXTUBATIONS WHILE THE ANCHORFAST ENDOTRACHEAL TUBE FASTENER WAS IN USE. IT WAS REPORTED THAT THE FACILITY DID NOT OBSERVE ANY DEVICE MALFUNCTION AND THEY ARE NOT SURE WHY THE UNPLANNED EXTUBATIONS HAPPENED. IT WAS FURTHER REPORTED THAT THERE WERE 17 UNPLANNED EXTUBATIONS THAT OCCURRED BETWEEN (B)(6) 2025 AND (B)(6) 2026. IT WAS REPORTED THROUGH CHART REVIEWS THAT THE PATIENT'S LEVEL OF SEDATION RANGED FROM MILD TO SEDATED, THE ANCHORFAST NECK STRAPS WERE IN USE, UNABLE TO DETERMINE HOW THE VENTILATOR CIRCUITS WERE SUPPORTED, ONLY ONE INCIDENT REPORTED FREQUENT DEVICE CHANGES DUE TO CLAMMY SKIN, BUT OTHERWISE, THEIR PRACTICE IS TO CHANGE THE ANCHORFAST DEVICE EVERY 48 HOURS AND AS NEEDED, AND THAT 2 OF THE 17 PATIENTS WERE BEING TURNED AT THE TIME OF THE UNPLANNED EXTUBATION. HOLLISTER IS WORKING WITH THE ACCOUNT TO PROVIDE TRAINING AND INSERVICING AS NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 24766043 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS 4 OUT OF 17 REPORTS. IT WAS REPORTED THAT THIS FACILITY OBSERVED AN INCREASE IN UNPLANNED ENDOTRACHEAL TUBE EXTUBATIONS WHILE THE ANCHORFAST ENDOTRACHEAL TUBE FASTENER WAS IN USE. IT WAS REPORTED THAT THE FACILITY DID NOT OBSERVE ANY DEVICE MALFUNCTION AND THEY ARE NOT SURE WHY THE UNPLANNED EXTUBATIONS HAPPENED. IT WAS FURTHER REPORTED THAT THERE WERE 17 UNPLANNED EXTUBATIONS THAT OCCURRED BETWEEN (B)(6) 2025 AND (B)(6) 2026. IT WAS REPORTED THROUGH CHART REVIEWS THAT THE PATIENT'S LEVEL OF SEDATION RANGED FROM MILD TO SEDATED, THE ANCHORFAST NECK STRAPS WERE IN USE, UNABLE TO DETERMINE HOW THE VENTILATOR CIRCUITS WERE SUPPORTED, ONLY ONE INCIDENT REPORTED FREQUENT DEVICE CHANGES DUE TO CLAMMY SKIN, BUT OTHERWISE, THEIR PRACTICE IS TO CHANGE THE ANCHORFAST DEVICE EVERY 48 HOURS AND AS NEEDED, AND THAT 2 OF THE 17 PATIENTS WERE BEING TURNED AT THE TIME OF THE UNPLANNED EXTUBATION. HOLLISTER IS WORKING WITH THE ACCOUNT TO PROVIDE TRAINING AND INSERVICING AS NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 24766042 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS 8 OUT OF 17 REPORTS. IT WAS REPORTED THAT THIS FACILITY OBSERVED AN INCREASE IN UNPLANNED ENDOTRACHEAL TUBE EXTUBATIONS WHILE THE ANCHORFAST ENDOTRACHEAL TUBE FASTENER WAS IN USE. IT WAS REPORTED THAT THE FACILITY DID NOT OBSERVE ANY DEVICE MALFUNCTION AND THEY ARE NOT SURE WHY THE UNPLANNED EXTUBATIONS HAPPENED. IT WAS FURTHER REPORTED THAT THERE WERE 17 UNPLANNED EXTUBATIONS THAT OCCURRED BETWEEN (B)(6) 2025 AND (B)(6) 2026. IT WAS REPORTED THROUGH CHART REVIEWS THAT THE PATIENT'S LEVEL OF SEDATION RANGED FROM MILD TO SEDATED, THE ANCHORFAST NECK STRAPS WERE IN USE, UNABLE TO DETERMINE HOW THE VENTILATOR CIRCUITS WERE SUPPORTED, ONLY ONE INCIDENT REPORTED FREQUENT DEVICE CHANGES DUE TO CLAMMY SKIN, BUT OTHERWISE, THEIR PRACTICE IS TO CHANGE THE ANCHORFAST DEVICE EVERY 48 HOURS AND AS NEEDED, AND THAT 2 OF THE 17 PATIENTS WERE BEING TURNED AT THE TIME OF THE UNPLANNED EXTUBATION. HOLLISTER IS WORKING WITH THE ACCOUNT TO PROVIDE TRAINING AND INSERVICING AS NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 24766041 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS 6 OUT OF 17 REPORTS. IT WAS REPORTED THAT THIS FACILITY OBSERVED AN INCREASE IN UNPLANNED ENDOTRACHEAL TUBE EXTUBATIONS WHILE THE ANCHORFAST ENDOTRACHEAL TUBE FASTENER WAS IN USE. IT WAS REPORTED THAT THE FACILITY DID NOT OBSERVE ANY DEVICE MALFUNCTION AND THEY ARE NOT SURE WHY THE UNPLANNED EXTUBATIONS HAPPENED. IT WAS FURTHER REPORTED THAT THERE WERE 17 UNPLANNED EXTUBATIONS THAT OCCURRED BETWEEN JUNE 2025 AND JANUARY 2026. IT WAS REPORTED THROUGH CHART REVIEWS THAT THE PATIENT'S LEVEL OF SEDATION RANGED FROM MILD TO SEDATED, THE ANCHORFAST NECK STRAPS WERE IN USE, UNABLE TO DETERMINE HOW THE VENTILATOR CIRCUITS WERE SUPPORTED, ONLY ONE INCIDENT REPORTED FREQUENT DEVICE CHANGES DUE TO CLAMMY SKIN, BUT OTHERWISE, THEIR PRACTICE IS TO CHANGE THE ANCHORFAST DEVICE EVERY 48 HOURS AND AS NEEDED, AND THAT 2 OF THE 17 PATIENTS WERE BEING TURNED AT THE TIME OF THE UNPLANNED EXTUBATION. HOLLISTER IS WORKING WITH THE ACCOUNT TO PROVIDE TRAINING AND INSERVICING AS NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 24766039 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS 7 OUT OF 17 REPORTS. IT WAS REPORTED THAT THIS FACILITY OBSERVED AN INCREASE IN UNPLANNED ENDOTRACHEAL TUBE EXTUBATIONS WHILE THE ANCHORFAST ENDOTRACHEAL TUBE FASTENER WAS IN USE. IT WAS REPORTED THAT THE FACILITY DID NOT OBSERVE ANY DEVICE MALFUNCTION AND THEY ARE NOT SURE WHY THE UNPLANNED EXTUBATIONS HAPPENED. IT WAS FURTHER REPORTED THAT THERE WERE 17 UNPLANNED EXTUBATIONS THAT OCCURRED BETWEEN (B)(6) 2025 AND (B)(6) 2026. IT WAS REPORTED THROUGH CHART REVIEWS THAT THE PATIENT'S LEVEL OF SEDATION RANGED FROM MILD TO SEDATED, THE ANCHORFAST NECK STRAPS WERE IN USE, UNABLE TO DETERMINE HOW THE VENTILATOR CIRCUITS WERE SUPPORTED, ONLY ONE INCIDENT REPORTED FREQUENT DEVICE CHANGES DUE TO CLAMMY SKIN, BUT OTHERWISE, THEIR PRACTICE IS TO CHANGE THE ANCHORFAST DEVICE EVERY 48 HOURS AND AS NEEDED, AND THAT 2 OF THE 17 PATIENTS WERE BEING TURNED AT THE TIME OF THE UNPLANNED EXTUBATION. HOLLISTER IS WORKING WITH THE ACCOUNT TO PROVIDE TRAINING AND INSERVICING AS NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 24766038 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS 3 OUT OF 17 REPORTS. IT WAS REPORTED THAT THIS FACILITY OBSERVED AN INCREASE IN UNPLANNED ENDOTRACHEAL TUBE EXTUBATIONS WHILE THE ANCHORFAST ENDOTRACHEAL TUBE FASTENER WAS IN USE. IT WAS REPORTED THAT THE FACILITY DID NOT OBSERVE ANY DEVICE MALFUNCTION AND THEY ARE NOT SURE WHY THE UNPLANNED EXTUBATIONS HAPPENED. IT WAS FURTHER REPORTED THAT THERE WERE 17 UNPLANNED EXTUBATIONS THAT OCCURRED BETWEEN JUNE 2025 AND JANUARY 2026. IT WAS REPORTED THROUGH CHART REVIEWS THAT THE PATIENT'S LEVEL OF SEDATION RANGED FROM MILD TO SEDATED, THE ANCHORFAST NECK STRAPS WERE IN USE, UNABLE TO DETERMINE HOW THE VENTILATOR CIRCUITS WERE SUPPORTED, ONLY ONE INCIDENT REPORTED FREQUENT DEVICE CHANGES DUE TO CLAMMY SKIN, BUT OTHERWISE, THEIR PRACTICE IS TO CHANGE THE ANCHORFAST DEVICE EVERY 48 HOURS AND AS NEEDED, AND THAT 2 OF THE 17 PATIENTS WERE BEING TURNED AT THE TIME OF THE UNPLANNED EXTUBATION. HOLLISTER IS WORKING WITH THE ACCOUNT TO PROVIDE TRAINING AND INSERVICING AS NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 24766037 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS 2 OUT OF 17 REPORTS.IT WAS REPORTED THAT THIS FACILITY OBSERVED AN INCREASE IN UNPLANNED ENDOTRACHEAL TUBE EXTUBATIONS WHILE THE ANCHORFAST ENDOTRACHEAL TUBE FASTENER WAS IN USE. IT WAS REPORTED THAT THE FACILITY DID NOT OBSERVE ANY DEVICE MALFUNCTION AND THEY ARE NOT SURE WHY THE UNPLANNED EXTUBATIONS HAPPENED. IT WAS FURTHER REPORTED THAT THERE WERE 17 UNPLANNED EXTUBATIONS THAT OCCURRED BETWEEN (B)(6) 2025 AND (B)(6) 2026. IT WAS REPORTED THROUGH CHART REVIEWS THAT THE PATIENT'S LEVEL OF SEDATION RANGED FROM MILD TO SEDATED, THE ANCHORFAST NECK STRAPS WERE IN USE, UNABLE TO DETERMINE HOW THE VENTILATOR CIRCUITS WERE SUPPORTED, ONLY ONE INCIDENT REPORTED FREQUENT DEVICE CHANGES DUE TO CLAMMY SKIN, BUT OTHERWISE, THEIR PRACTICE IS TO CHANGE THE ANCHORFAST DEVICE EVERY 48 HOURS AND AS NEEDED, AND THAT 2 OF THE 17 PATIENTS WERE BEING TURNED AT THE TIME OF THE UNPLANNED EXTUBATION. HOLLISTER IS WORKING WITH THE ACCOUNT TO PROVIDE TRAINING AND INSERVICING AS NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 24765981 ↗
• MalfunctionFeb 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE NON-ABSORBENT UPPER LIP STABILIZER OF THE HOLLISTER ANCHORFAST DEVICE FELL OFF WHILE IN USE ON A PATIENT AND LANDED IN THE PATIENT'S MOUTH. IT WAS FURTHER REPORTED THAT IT WAS EASILY RETRIEVED FROM THE MOUTH. IT WAS REPORTED THAT THE ANCHORFAST DEVICE WAS CHANGED OUT FOR A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414086 ↗
• InjuryNov 4, 2025Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT A PATIENT AT A HEALTHCARE FACILITY SUSTAINED AN UPPER LIP INJURY WHILE USING THE HOLLISTER ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER. IT WAS REPORTED THAT THE INJURY REQUIRED SURGICAL INTERVENTION.

  Patient problems: Tissue Breakdown

  MAUDE report 23463845 ↗
• InjurySep 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN RN WAS ALERTED BY THE VITAL SIGNS MONITOR TO A PATIENT'S SPO2 DECREASING. IT WAS REPORTED THAT UPON ENTRY TO ROOM, THEY WITNESSED PATIENT IN A COUGHING FIT, AND THE ENDOTRACHEAL TUBE ACTIVELY TIDALING IN DEPTH WITH FORCEFUL EXHALATIONS. IT WAS REPORTED THAT THE RN TOOK MANUAL CONTROL OF THE ET TUBE AND NOTED THAT THE TUBE HAD MIGRATED TO APPROXIMATELY 20CM AT THE TEETH FROM 24CM. IT WAS REPORTED THAT THE REGISTERED RESPIRATORY THERAPIST ATTENDED, AND THE TUBE WAS RE-INSERTED TO ORIGINAL DEPTH. IT WAS REPORTED THAT DURING THE RRT ASSESSMENT, THE HOLLISTER ANCHORFAST ENDOTRACHEAL TUBE SECUREMENT DEVICE WAS NOTED TO HAVE LOOSENED SPONTANEOUSLY. IT WAS ALSO REPORTED THAT ALL CLAMPS ON ANCHORFAST DEVICE REMAIN LOCKED AND THAT NO TEARS OR DAMAGE NOTED. IT WAS REPORTED THAT THE PATIENT'S SPO2 DECREASED BELOW 80% FOR APPROXIMATELY 60 SECONDS DUE TO EQUIPMENT FAILURE / SPONTANEOUS ENDOTRACHEAL TUBE MIS-POSITIONING & MASSIVE AIR LEAK.

  Patient problems: Cough; Low Oxygen Saturation

  MAUDE report 23014736 ↗
• InjurySep 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS AN ACCIDENTAL ENDOTRACHEAL TUBE EXTUBATION IN WHICH A PATIENT COUGHED, PUSHED, AND RELEASED BOTH THE NECK BAND AND THE HYDROCOLLOID OF THE HOLLISTER ANCHORFAST DEVICE. IT WAS FURTHER REPORTED THAT THERE WAS A CLINICIAN NEARBY WHO RETRIEVED THE NECESSARY MATERIALS AND REINTUBATED THE PATIENT WITHOUT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23014735 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHOSE ENDOTRACHEAL TUBE WAS BEING SECURED BY THE HOLLISTER ANCHORFAST ENDOTRACHEAL TUBE FASTENER EXPERIENCED AN UPPER LIP INJURY CHARACTERIZED BY EXTERNAL NECROSIS, WHICH ULTIMATELY REQUIRED SURGICAL REPAIR.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 23014734 ↗
• InjuryJan 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ORALLY INTUBATED PATIENT SAT UP IN BED INDEPENDENTLY. IT WAS FURTHER REPORTED THAT THIS CAUSED A CERTAIN AMOUNT OF TENSION ON THE ENDOTRACHEAL TUBE AND CONSEQUENTLY ALSO ON THE ANCHORFAST DEVICE. IN ADDITION, IT WAS REPORTED THAT THE CLAMP COULD NOT BE LOCKED PROPERLY IN PLACE AFTER BEING MOVED SEVERAL TIMES AND THAT DURING THE TIME THE TENSION WAS APPLIED, THE ANCHORFAST CLAMP DETACHED FROM THE END OF THE ANCHORFAST TRACK AND THE ET TUBE WAS NO LONGER FIXED TO THE PATIENT. IT WAS REPORTED THAT THE ET TUBE SLIPPED OUT OF POSITION AND NEEDED TO BE REPOSITIONED. IT WAS ADDITIONALLY REPORTED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21228451 ↗
• InjuryJan 14, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT WHO WAS USING THE HOLLISTER ANCHORFAST ENDOTRACHEAL TUBE HOLDER, AND WAS AWAKE AND APPROPRIATE, EXPERIENCED AN ET TUBE SLIPPAGE OF 3 CM THROUGH THE ET TUBE WRAP WHILE THE SKIN BARRIER PADS REMAINED SECURE TO THE PATIENT'S FACE. IT WAS FURTHER REPORTED THAT THIS DID NOT LEAD TO AN EXTUBATION, BUT THE FACILITY OPTED TO REMOVE THE ANCHORFAST DEVICE AND REPLACE IT WITH TAPE TO SECURE THE ET TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21151592 ↗