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AMT Bridle™ E4-4112Recalls & reported problems

Applied Medical Technology, Inc. · 12F AMT Bridle Nasal Tube Retaining System (Pouched) · Class 2

All models of AMT Bridle (4)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842071103958), received between Nov 9, 2018 and Nov 9, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Positioning Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Positioning Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionNov 9, 2018Positioning Problem

    AT END OF PROCEDURE, THE RESIDENT ATTEMPTED TO PLACE BRIDLE AND WAS HAVING DIFFICULTY. SECOND RESIDENT ATTEMPTED TO HELP PLACE BRIDLE. MAGNET FROM BRIDLE WAS LOST IN PATIENT. ENT WAS CONSULTED. ENT PA WAS UNABLE TO VISUALIZE FOREIGN BODY. X-RAY WAS TAKEN. FOREIGN BODY WAS SEEN ON X-RAY OF PATIENT'S HEAD. ENT ATTENDING CAME TO OPERATING ROOM (OR) FOR EMERGENT FOREIGN BODY RETRIEVAL. ATTENDING WAS UNSUCCESSFUL. BOTH ATTENDINGS AGREED PATIENT WAS SAFE TO BE EXTUBATED. ATTENDINGS AGREED TO SCHEDULE A CT SCAN FOR PATIENT AND NOTIFY NURSING STAFF TO MONITOR PATIENT'S EXPECTANT FOR FOREIGN BODY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8054625 ↗

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

Other Tubes, Gastrointestinal (And Accessories) devices

All Tubes, Gastrointestinal (And Accessories) devices →

Sources and updates

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