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AMT Bridle™ Pro E4-421618Recalls & reported problems

Applied Medical Technology, Inc. · 16 - 18 FR AMT Bridle Pro Nasal Tube Retaining System (Pouched) · Class 2

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842071115890), received between Jun 5, 2024 and Jun 5, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Unintended Movement” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Unintended Movement1

Patient problems

  • Airway Obstruction1
  • Aspiration/Inhalation1

Recent adverse event reports

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

  • InjuryJun 5, 2024Unintended Movement; Unintended Movement

    IT WAS REPORTED ON 05/07/2024 BY (B)(6) OF (B)(6) MEDICAL CENTER THAT, "ONE OF OUR NURSES WAS BRIDLING A CORTRAK SMALL BORE FEEDING TUBE AND THE BLUE PROBE WITH THE MAGNET ON IT WAS SUCKED DOWN INTO THE PATIENT. THE PATIENT WAS ON THE VENTILATOR, BUT A CHEST XRAY WAS PERFORMED AND YOU CAN SEE THE MAGNET FROM THE PROBE. THE MD HAD TO GO IN WITH FORCEPS AND RETRIEVE IT". SHE ALSO NOTED THAT, "THIS IS THE FIRST TIME WE HAVE SEEN THIS. THE NURSE STATES SHE HAD THE PROBE ABOUT 2/3 OF THE WAY IN AND THAT SHE HAD A FIRM GRIP ON IT".

    Patient problems: Airway Obstruction; Aspiration/Inhalation

    MAUDE report 19473582 ↗

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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