AnchorFast Guard 9800 (UDI 00610075095780)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00610075095780), received between Dec 13, 2024 and Aug 7, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Break

  It was reported that while a patient was using a Hollister AnchorFast Guard Oral Endotracheal Tube Fastener, the clip thumbtab broke during an endotracheal tube (ETT) adjustment. It was further reported that the broken clip migrated into the patient's airway, requiring extensive investigations to determine its location. It was additional reported that the clip was subsequently identified in the left lower lobe bronchus and was retrieved via bronchoscopy on (b)(6) 2026. No residual patient harm was reported following retrieval of the device.

  Patient problems: Foreign Body In Patient

  MAUDE report 50175659 ↗
• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO WAS USING A HOLLISTER ANCHORFAST GUARD ORAL ENDOTRACHEAL TUBE FASTENER EXPERIENCED AN UPPER LIP INJURY. IT WAS REPORTED THAT THE ANCHORFAST GUARD HAD BEEN IN PLACE FOR 16 DAYS OVER MULTIPLE DEVICES AND THAT THEY USED A FOAM DRESSING UNDER THE LIP FOAM ONCE THEY NOTICED EVIDENCE OF PRESSURE STARTING. IN ADDITION, THEY REPORTED THAT THE PATIENT WAS SWEATY, AND THE PRODUCT WAS SLIPPING. THEY FURTHER REPORTED THAT THE PATIENT EXPERIENCED A FULL THICKNESS UPPER LIP INJURY AND REQUIRED MEDICAL TREATMENT TO ADDRESS.

  Patient problems: Tissue Breakdown

  MAUDE report 20923755 ↗