AnchorFast Guard 9800 (UDI 00610075186518)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00610075186518), received between Jun 13, 2023 and Mar 31, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).

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-1181-2025 · Root cause: Process change control · FDA record ↗

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.

• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SKIN INJURY WAS OBSERVED BENEATH THE ADHESIVE BARRIER CHEEK PAD DURING REMOVAL OF THE HOLLISTER ANCHORFAST GUARD DEVICE. IT WAS REPORTED THAT THE DEVICE HAD BEEN IN PLACE FOR 7 DAYS AND DURING A PERIOD OF THAT TIME, THE PATIENT HAD BEEN PLACED IN THE LATERAL POSITION. IT WAS REPORTED THAT A MEDICATED OINTMENT AND A SKIN BARRIER WERE USED AS TREATMENT FOR THE INJURY. HOLLISTER HAS SINCE PROVIDED EDUCATION TO THE ACCOUNT.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 24749193 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTUBATED PATIENT DEVELOPED A STAGE IV UPPER LIP PRESSURE INJURY WITH FULL-THICKNESS SKIN AND TISSUE LOSS AND EXPOSED TEETH WHILE USING THE HOLLISTER ANCHORFAST GUARD ENDOTRACHEAL TUBE HOLDER. IT WAS FURTHER REPORTED THAT THE WOUND EVOLVED QUICKLY AND THE PATIENT REQUIRED DEBRIDEMENT OF THE WOUND AND SURGICAL REPAIR OF HIS LIP BY MAXILLOFACIAL ORAL SURGERY.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 24367433 ↗
• InjuryFeb 17, 2026Loss of or Failure to Bond

  IT WAS REPORTED TO HOLLISTER THROUGH AN FDA MEDWATCH THE FOLLOWING: DURING HEAD TURN OF A PRONE PATIENT, THE ANCHORFAST CLIP BROKE CAUSING ENDOTRACHEAL TUBE DISLODGEMENT.

  Patient problems: Insufficient Information

  MAUDE report 24367086 ↗
• MalfunctionJun 13, 2023Adverse Event Without Identified Device or Use Problem

  PATIENT DEVELOPED A NON-STAGEABLE INJURY TO THE MUCOSAL LIP WHERE THE ANCHORFAST WAS LOCATED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17117083 ↗