AMT Bridle™ Pro E4-420810Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842071115876), received between Jun 16, 2025 and Aug 8, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2025No Apparent Adverse Event; No Apparent Adverse Event

  PER THE ORIGINAL REPORTER IN MEDSUN REPORT #: (B)(4), IT WAS REPORTED THAT, "FEEDING TUBE GOT PULLED THROUGH THE INTACT BRIDLE AND WAS NO LONGER IN THE CORRECT POSITION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22753087 ↗
• MalfunctionJul 14, 2025Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event

  PER THE ORIGINAL REPORTER IN UF REPORT #:(B)(4), IT WAS REPORTED THAT, "WHILE TRYING TO BRIDLE THE PT.'S DUOTUBE, IT WAS DISCOVERED THAT ONE OF THE MAGNETS FELL OFF THE END WHEN TRYING TO REMOVE AND REPOSITION THE STYLETS. THE MAGNET WAS CONNECTED TO THE OPPOSITE STYLET UPON REMOVAL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22497240 ↗
• MalfunctionJun 16, 2025Detachment of Device or Device Component

  WHILE TRYING TO BRIDLE THE PT.'S DUOTUBE, IT WAS DISCOVERED THAT ONE OF THE MAGNETS FELL OFF THE END WHEN TRYING TO REMOVE AND REPOSITION THE STYLETS. THE MAGNET WAS CONNECTED TO THE OPPOSITE STYLET UPON REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211394 ↗

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.