AMT Bridle Pro™ E4-4218Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842071118112), received between Nov 4, 2021 and Nov 4, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K030784, K142971); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2021Improper or Incorrect Procedure or Method

  PER THE ORIGINAL REPORTER IN MEDWATCH REPORT #: (B)(4). "THE PATIENT PULLED HIS NGT OUT WITH THE BRIDLE AND TORE HIS SEPTUM. HE'S HAD MULTIPLE PROCEDURES TO CONTROL THE BLEEDING AND THIS LAST TIME ENDED UP AGAIN IN ICU INTUBATED."

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 12755321 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030784, K142971. One submission often covers many models, so check the product and lot details in each record.

• Z-1224-2017 · Jan 19, 2017 · Terminated
  AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.
• Z-1223-2017 · Jan 19, 2017 · Terminated
  AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes.