AnchorFast 9799 (UDI 00610075095766)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00610075095766), received between Apr 25, 2025 and May 13, 2026 — classified as 13 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (8 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE MEDWATCH THAT THE PATIENT SUSTAINED A PRESSURE INJURY TO THE UPPER LIP, LIKELY FROM MECHANICAL VENTILATION/ETT HOLDER (ANCHOR FAST). IN ADDITION, IT WAS REPORTED IN THE MEDWATCH THAT NECROTIC TISSUE EXTENDED FROM THE LIP INTO THE MUCOSAL SURFACE OF THE INNER LIP. FURTHER, IT WAS REPORTED IN THE MEDWATCH THAT NECROSIS ON THE UPPER LIP WOUND WAS HEALING BUT FULL THICKNESS DEFECT REMAINED. IT WAS REPORTED IN THE MEDWATCH THAT DEBRIDEMENT WAS COMPLETED ON THE UPPER LIP OPEN WOUND AND RECONSTRUCTION WITH COMPLEX LAYERED CLOSURE WAS COMPLETED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 25161847 ↗
• InjuryMar 20, 2026Material Separation

  IT WAS REPORTED THAT THE UPPER LIP STABILIZER ON THE HOLLISTER ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER DETACHED LEADING TO SKIN DAMAGE TO THE UPPER LIP. IT WAS FURTHER REPORTED THAT THE DAMAGE WENT THROUGH TO THE INSIDE OF THE UPPER LIP WHICH HAS RESULTED IN NUMBNESS AND NERVE INVOLVEMENT FOR THE PATIENT POST CRITICAL CARE.

  Patient problems: Tissue Breakdown

  MAUDE report 24654482 ↗
• InjuryFeb 26, 2026Material Separation

  IT WAS REPORTED TO HOLLISTER VIA AN FDA MEDWATCH THE FOLLOWING: UPON INSPECTION, THE HOLLISTER ANCHORFAST ORAL ETT FASTENER, MODEL 9799, WAS FOUND TO BE DEFECTIVE. THE ISSUE WAS FIRST IDENTIFIED WHEN THE PATIENT'S NURSE DISCOVERED THAT THE FOAM STABILIZATION PAD HAD DETACHED FROM THE MAIN DEVICE BODY. THE DEFECT WAS DETECTED DURING A ROUTINE PATIENT ASSESSMENT. THE ANCHORFAST DEVICE FAILED TO MAINTAIN A SECURE AND PROTECTIVE INTERFACE WITH THE PATIENT'S SKIN AND MUCOSA, RESULTING IN A STAGE IV HAPI TO THE UPPER LIP AND AN UNSTAGEABLE MUCOSAL MEMBRANE INJURY. THE DEFICIENCY WAS VERIFIED BY THE PATIENT'S PRIMARY CARE TEAM AND THE WOUND CARE NURSE. PHOTOGRAPHS OF THE INJURY ARE ATTACHED. THE DEVICE APPEARED TO HAVE FOAM ADHESIVE DELAMINATION AND BONDING FAILURE BETWEEN THE FOAM PAD AND THE PLASTIC ANCHOR PLATE, CONSISTENT WITH A POTENTIAL MATERIAL OR MANUFACTURING DEFECT. ADDITIONALLY, THE EVENT INVOLVED USER DEVIATION FROM THE MANUFACTURER'S IFU. THE ROOT CAUSE IN MULTIFACTORIAL, INVOLVING BOTH PRODUCT INTEGRITY AND HUMAN FACTORS. HOLLISTER HAS NOT RECEIVED THE STATED PHOTOGRAPHS.

  Patient problems: Tissue Breakdown

  MAUDE report 24460928 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SELF-EXTUBATION BY COUGHING OUT THEIR ENDOTRACHEAL TUBE WHILE THE TUBE WAS BEING SECURED BY THE HOLLISTER ANCHORFAST ENDOTRACHEAL TUBE HOLDER. IT WAS REPORTED THAT LIMITED INFORMATION WAS AVAILABLE, BUT THE DEVICES ARE ROUTINELY REPLACED EVERY 48 HOURS AND ARE SHUTTLED EVERY 4 HOURS.IT WAS ADDITIONALLY REPORTED THAT THE LOT NUMBER WAS NOT KNOWN, THE DEVICE WAS NOT RETURNED OR SAVED FOR EVALUATION, NO DEVICE DEFECT WAS REPORTED, AND THE PATIENT'S CONDITION FOLLOWING THE EVENT WAS NOT KNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24444631 ↗
• InjuryFeb 13, 2026Loss of or Failure to Bond

  IT WAS REPORTED TO HOLLISTER THROUGH AN FDA MEDSUN THE FOLLOWING: PATIENT TURNED FOR INCONTINENT CARE. INITIALLY TURNED TO PT'S RIGHT SIDE, WHEN TURNED ONTO BACK (BEFORE BEING TURNED TO LEFT SIDE), ANOTHER RN NOTED ETT [ENDOTRACHEAL TUBE] MOVE OUT. ANCHORFAST WAS IN PLACE WITH SECUREMENT STRAP ON. RESPIRATORY THERAPIST NEARBY AND IMMEDIATELY CAME TO BEDSIDE. APP [ADVANCE PRACTICE PRACTITIONER] AND INTENSIVIST CALLED TO BEDSIDE. ETT REMOVED AND NEW ETT INSERTED BY INTENSIVIST. PRIOR TO TURN ETT WAS ASSESSED AND IN CORRECT POSITION.

  Patient problems: Insufficient Information

  MAUDE report 24336542 ↗
• InjuryJan 26, 2026Labelling, Instructions for Use or Training Problem; Malposition of Device; Protective Measures Problem

  A REPORT WAS RECEIVED FROM A NURSE THAT A PATIENT USING THE ANCHORFAST ORAL ENDOTRACH TUBE FASTENER REPORTEDLY SUSTAINED AN INJURY. IT WAS REPORTED THAT THE PATIENT DEVELOPED A HOLE IN THE LIP. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Abrasion

  MAUDE report 24179222 ↗
• InjuryDec 15, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE SMALL PLASTIC TAB WHICH SECURES THE TUBE BROKE OFF AND FELL INTO THE PATIENT'S MOUTH. SKU UNKNOWN, LOT # 5G032.THE EVENT WAS DESCRIBED AS: REGISTERED NURSE (RN) REPORTEDLY NOTICED THAT IT WAS "DEEP IN THE MOUTH" AND WAS "UNABLE TO BE RETRIEVED". IT WAS REPORTED THAT THE MEDICAL DOCTOR USED A LARYNGOSCOPE TO "VISUALIZE THE PLASTIC PIECE BUT WAS UNABLE TO REMOVE IT WITH A YANKAUER AND FORCEPS DUE TO SECRETIONS, ANGLE, AND POSITIONING OF THE PIECE". IT WAS REPORTED THAT "FURTHER ATTEMPTS WERE MADE BY THE MEDICAL DOCTOR WITH BRONCHOSCOPE VIA NASAL PASSAGEWAY WHICH WAS SAID TO BE NOT SUCCESSFUL IN VISUALIZING PLASTIC PIECE". CT (COMPUTED TOMOGRAPHY) SCANS REPORTEDLY DID NOT REVEAL ANY RADIOPAQUE FOREIGN BODIES.

  Patient problems: Aspiration/Inhalation

  MAUDE report 23801911 ↗
• InjuryNov 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE HOLLISTER ANCHORFAST ENDOTRACHEAL TUBE FASTENER'S CLAMP BROKE FREE FROM THE TRACK, RESULTING IN AN UNPLANNED EXTUBATION, AND SUBSEQUENT REINTUBATION OF THE PATIENT WAS NEEDED. IT WAS REPORTED THAT THE SPECIFIC LOT NUMBER AND OTHER IDENTIFYING DETAILS OF THE DEVICE ARE UNKNOWN; HOWEVER, THE DEVICE HAD BEEN PLACED SIX DAYS PRIOR TO THE EVENT AND HAD NOT EXHIBITED ANY ISSUES BEFORE THIS ISSUE. IT WAS REPORTED THAT THE DEVICE WAS DISCARDED BY THE ICU NURSE FOLLOWING THE INCIDENT.

  Patient problems: Hypoventilation

  MAUDE report 23582076 ↗
• InjuryNov 13, 2025Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT A PATIENT WITH AN ANCHORFAST ENDOTRACHEAL TUBE FASTENER IN PLACE SUSTAINED AN UPPER LIP INJURY. IT WAS FURTHER REPORTED THAT THE INJURY WAS FULL THICKNESS, AND THE TOP LIP BECAME DETACHED AND REQUIRED SURGICAL REPAIR. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT WAS BELIEVED TO HAVE WORN THE ANCHORFAST DEVICE FOR APPROXIMATELY 24-48 HOURS. IT WAS ALSO REPORTED THAT THE PATIENT HAD SIGNIFICANT UNDERLYING MEDICAL CONDITIONS.

  Patient problems: Tissue Breakdown

  MAUDE report 23543106 ↗
• InjuryAug 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT WHO HAD THE HOLLISTER ANCHORFAST ENDOTRACHEAL TUBE FASTENER IN PLACE SELF-EXTUBATED. IT WAS FURTHER REPORTED THAT THE STAFF WERE WEANING THE PATIENT OFF OF SEDATION IN PREPARATION FOR A PLANNED EXTUBATION WHEN THIS EVENT HAPPENED. IT WAS REPORTED THAT THE PATIENT WAS EITHER UNDER MINIMAL OR NO SEDATION AT THE TIME AND THE PATIENT HAD MITTS ON THEIR HANDS TO PREVENT THEM FROM GRABBING AT THE TUBE. IT WAS ALSO REPORTED THAT STAFF HAD ASSESSED THE PATIENT SHORTLY PRIOR TO THE EXTUBATION AND OBSERVED THAT THE ANCHORFAST DEVICE WAS SECURELY IN PLACE. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT WAS ABLE TO REMAIN EXTUBATED ON AN AEROSOL MASK POST EXTUBATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22699308 ↗
• MalfunctionJul 30, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  EVENT 1 OF 2. IT WAS REPORTED THAT AFTER THE HOLLISTER ANCHORFAST ENDOTRACHEAL TUBE FASTENER HAD BEEN IN PLACE FOR 7 DAYS, THE ETT MIGRATED UP. IT WAS FURTHER REPORTED THAT THERE WAS LACK OF ADHESIVE INTEGRITY. ADDITIONALLY, IT WAS REPORTED THERE WAS NO CHANGE IN VITAL SIGNS, OR PATIENT HARM AND THAT THE ANCHORFAST WAS REPLACED WITH A NEW ONE AND NO X RAYS WERE TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22662953 ↗
• MalfunctionJul 30, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  EVENT 2 OF 2. IT WAS REPORTED THAT AFTER THE HOLLISTER ANCHORFAST ENDOTRACHEAL TUBE FASTENER HAD BEEN IN PLACE, THE ETT MIGRATED UP. IT WAS FURTHER REPORTED THAT THERE WAS LACK OF ADHESIVE INTEGRITY. ADDITIONALLY, IT WAS REPORTED THERE WAS NO CHANGE IN VITAL SIGNS, OR PATIENT HARM AND THAT THE ANCHORFAST WAS REPLACED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22662952 ↗
• InjuryJul 17, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT BECAUSE THE CHEEK BARRIER PADS ON THE HOLLISTER ANCHORFAST WERE NOT AS STICKY, THE ETT MIGRATED OUT AND THE PATIENT WAS AT RISK FOR LOSING BREATHING TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531574 ↗
• MalfunctionJul 8, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT A PATIENT WHO HAD A HOLLISTER ANCHORFAST ENDOTRACHEAL TUBE FASTENER IN PLACE TO SECURE AN ET TUBE WAS DISCOVERED TO HAVE THE ANCHORFAST UPPER LIP SPACER IN THE BACK OF THEIR THROAT UPON PREPARING FOR REINTUBATION. IT WAS REPORTED THAT THE PIECE WAS REMOVED BY SUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22435688 ↗
• InjuryJul 2, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON RN'S FINAL ASSESSMENT PRIOR TO LEAVING PATIENT ALONE FOR CT, PATIENT WHO HAD AN ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER IN PLACE WAS NOTED TO HAVE A NEW ENDOTRACHEAL TUBE CUFF LEAK. IT WAS REPORTED THAT THE RN REPOSITIONED THE PATIENT'S HEAD IN ATTEMPT TO RESOLVE LEAK WITH NO EFFECT, THEN ASSESSED THE ET TUBE WHICH WAS FOUND TO HAVE MIGRATED SIGNIFICANTLY. IT WAS REPORTED THAT THE FINAL 19CM MARKER OF 6.0 TUBE WAS NOTED TO BE PROTRUDING MANY CM'S PAST PT'S TEETH. IT WAS REPORTED THAT THE RN TOOK MANUAL CONTROL OF ET TUBE, ASSUMING THE AIRWAY WAS COMPROMISED. IT WAS REPORTED THAT THE RRT APPROACHED THE BEDSIDE TO ASSESS, AND ADVANCED THE ET TUBE TO 25CM, AND STATED THAT THE AIRWAY WAS CURRENTLY SAFE BUT REQUIRED URGENT ASSESSMENT. IT WAS REPORTED THAT THERE WAS A NORMAL ETCO2 WAVEFORM NOTED ON ASSESSMENT, AND THE PATIENT'S VITAL SIGNS WITH SPO2 WAS HIGHER THAN 92% THROUGHOUT. IT WAS REPORTED THAT THE INTENSIVIST ARRIVED AND REQUESTED BRONCHOSCOPY EQUIPMENT AND THAT PATIENT NOT BE MOVED UNTIL DETERMINATION OF SAFETY WAS MADE. IT WAS REPORTED THAT THE ET TUBE DETERMINED TO REMAIN AT INADEQUATE DEPTH AND THE TUBE WAS ADVANCED UNDER SUPERVISION OF ICU INTENSIV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22381937 ↗
• InjuryJun 26, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ANCHORFAST BARRIER DID NOT ADHERE TO THE SKIN, WAS VERY SOFT, DOES NOT KEEP THE ENDOTRACHEAL TUBE IN PLACE, KEPT MOVING AROUND, AND BENDS FORWARD. IT WAS REPORTED THAT THEY HAVE BEEN CHANGING THE ANCHORFAST 3 TIMES PER DAY ON ONE PATIENT. IT WAS FURTHER REPORTED THAT ON ONE PATIENT, THE ET TUBE CAME OUT COMPLETELY AND THE PATIENT REQUIRED REINTUBATION. THEY REPORTED THAT THE PATIENT WAS BEING WEANED OFF THE VENTILATOR TO PREPARE FOR EXTUBATION HOWEVER WAS NOT YET READY FOR EXTUBATION WHEN THIS HAPPENED. THEY REPORTED THAT THIS PATIENT CURRENTLY REMAINS INTUBATED.

  Patient problems: Hyperventilation

  MAUDE report 22335224 ↗
• MalfunctionJun 16, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE UPPER LIP SPACER FROM AN ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER WAS FOUND TO BE LOOSE ON A PATIENT'S FACE. IT WAS FURTHER REPORTED THAT IT WAS GOING TO BE CHANGED AFTER TWO DAY'S USE WHEN THE SPACER THAT IS USUALLY ON THE TOP LIP WAS MISSING AND FOUND IN THE PATIENTS' THROAT. IT WAS REPORTED THAT THE CLINICIAN HAD TO USE FORCEPS TO RETRIEVE THE PIECE. IT WAS FURTHER REPORTED THAT THE PATIENT REMAINED INTUBATED DURING THE ENTIRE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22210525 ↗
• MalfunctionMay 14, 2025Material Separation; Material Separation

  THIS IS FOR THE SECOND OF TWO PATIENTS. IT WAS REPORTED THAT AN ACCOUNT HAD A PATIENT WHO HAD A HOLLISTER ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER IN PLACE AND WHEN THE RT DID THEIR PATIENT ASSESSMENT, THE UPPER LIP SPACER WAS NOTED TO BE NO LONGER ADHERING TO THE PLASTIC LIP PIECE AND FALLING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019862 ↗
• MalfunctionMay 14, 2025Material Separation; Material Separation

  THIS IS FOR THE FIRST OF TWO PATIENTS. IT WAS REPORTED THAT AN ACCOUNT HAD A PATIENT WHO HAD A HOLLISTER ANCHOR FAST ORAL ENDOTRACHEAL TUBE FASTENER IN PLACE AND WHEN THE RT DID THEIR PATIENT ASSESSMENT, THE UPPER LIP SPACER WAS NOTED TO BE NO LONGER ADHERING TO THE PLASTIC LIP PIECE AND FALLING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019860 ↗
• MalfunctionApr 28, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE UPPER LIP FOAM SPACER FROM AN ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER SEPARATED FROM THE PLASTIC ANCHORFAST TRACK ON A PATIENT WHO HAD THE DEVICE IN PLACE FOR 9 HOURS. IT WAS REPORTED THAT THIS SEPARATION WAS NOT WITNESSED AND THE NURSE USED SUCTION TO RETRIEVE THE LIP FOAM SPACER FROM THE BACK OF THE PATIENT'S THROAT WHILE THE PATIENT WAS STILL ORALLY INTUBATED. IT WAS FURTHER REPORTED THAT THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917496 ↗
• MalfunctionApr 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE LIP SPACER SEPARATED FROM THE HOLLISTER ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER WHILE IT WAS IN USE ON A PATIENT. IT WAS FURTHER REPORTED THAT THE SPACER LANDED IN THE PATIENT'S MOUTH. ADDITIONALLY, IT WAS REPORTED THAT THE DEVICE WAS NOT SAVED, THERE WERE NO PHOTOS, THE LOT NUMBER WAS NOT KNOWN, AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909207 ↗