AnchorFast SlimFit 9787Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00610075095834), received between Apr 17, 2025 and Apr 28, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Dec 23, 2024Class IIOpen, Classified

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

   Z-1179-2025 · Root cause: Process change control · Recall details · 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.

• 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 SLIMFIT ORAL ENDOTRACHEAL TUBE FASTENER SEPARATED FROM THE PLASTIC ANCHORFAST SLIMFIT TRACK ON A PATIENT WHO HAD THE DEVICE IN PLACE FOR 7 HOURS. IT WAS REPORTED THAT THIS SEPARATION WAS NOT WITNESSED, AND THE PIECE WAS FOUND HANGING ON THE OUTSIDE OF THE PATIENT'S MOUTH. IT WAS FURTHER REPORTED THAT THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917495 ↗
• MalfunctionApr 17, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THIS IS THE THIRD OF THREE REPORTS FROM THE SAME ACCOUNT WITH THE SAME SKU AND LOT NUMBER. IT WAS REPORTED THAT THE UPPER LIP FOAM SPACER FROM AN ANCHORFAST SLIMFIT ORAL ENDOTRACHEAL TUBE FASTENER SEPARATED FROM THE PLASTIC ANCHORFAST SLIMFIT TRACK WHILE IN USE ON A PATIENT. IT WAS REPORTED THAT THE DETAILS REGARDING WHERE THE SEPARATED UPPER LIP FOAM SPACER LANDED WAS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21861341 ↗
• MalfunctionApr 17, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THIS IS THE SECOND OF THREE REPORTS FROM THE SAME ACCOUNT WITH THE SAME SKU AND LOT NUMBER. IT WAS REPORTED THAT THE UPPER LIP FOAM SPACER FROM AN ANCHORFAST SLIMFIT ORAL ENDOTRACHEAL TUBE FASTENER SEPARATED FROM THE PLASTIC ANCHORFAST SLIMFIT TRACK WHILE IN USE ON A PATIENT. IT WAS REPORTED THAT THE DETAILS REGARDING WHERE THE SEPARATED UPPER LIP FOAM SPACER LANDED WAS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860423 ↗
• MalfunctionApr 17, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THIS IS THE FIRST OF THREE REPORTS FROM THE SAME ACCOUNT WITH THE SAME SKU AND LOT NUMBER. IT WAS REPORTED THAT THE UPPER LIP FOAM SPACER FROM AN ANCHORFAST SLIMFIT ORAL ENDOTRACHEAL TUBE FASTENER SEPARATED FROM THE PLASTIC ANCHORFAST SLIMFIT TRACK WHILE IN USE ON A PATIENT. IT WAS FURTHER REPORTED THAT THERE WAS AN UPPER LIP PRESSURE INJURY. IT WAS REPORTED THAT NEITHER THE DETAILS REGARDING THE UPPER LIP PRESSURE INJURY NOR INFORMATION ABOUT WHERE THE SEPARATED UPPER LIP FOAM SPACER LANDED WAS AVAILABLE.

  Patient problems: Tissue Breakdown

  MAUDE report 21860156 ↗