AMT Bridle™ Pro E4-421214Recalls & reported problems
Applied Medical Technology, Inc. · 12 - 14 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842071115883), received between May 3, 2024 and May 3, 2024 — classified as 1 malfunction.
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
Most reported problems
Device problems
- No Apparent Adverse Event1
Patient problems
- Skin Tears1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 3, 2024No Apparent Adverse Event; No Apparent Adverse Event
PER THE ORIGINAL REPORTER IN UF #(B)(4): THE "ENVUE AND BRIDLE HAVE BEEN IN FOR WEEKS. BRIDLE NOTED TO BE EMBEDDED IN PT OUTER SEPTUM ON INSIDE OF RIGHT NARE. THE ENVUE WAS SITTING ON PT LEFT SIDE WITH TUBE FEEDING INFUSING. THE BRIDLE HAD SCABBED INTO THE DEEP PORTION OF THE PRESSURE INJURY. BRIDLE REMOVED BY PHYSICIAN.".
Patient problems: Skin Tears
MAUDE report 19238476 ↗
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 · TerminatedAMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes.
- Z-1224-2017 · Jan 19, 2017 · TerminatedAMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.
Other Tubes, Gastrointestinal (And Accessories) devices
- Bard® DigniShield® Stool Management System SMS002C. R. Bard, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 deaths525 reports
- CORTRAK* 2 ENTERAL ACCESS SYSTEM 20-0950Avanos Medical, Inc. · Tubes, gastrointestinal (and accessories)1 recall22 deaths134 reports
- Bard Tri-Funnel Replacement Gastrostomy Tube 000720Bard Access Systems, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 death170 reports
- EndoVive Safety PEG Kit M00566470Boston Scientific Corporation · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall1 death111 reports
- Kangaroo 8884711253Cardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)152 reports
- NutraGlide Nasal Feeding Tube ENFT-05055-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-06055-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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