AMT Bridle™ E4-4110Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842071103941), received between Jul 12, 2022 and Jul 12, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 FDA recall record name this device's identifier.

1 other recall 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.

Recalls naming this device

1. Jan 19, 2017Terminated

   Expired expiration dates are listed on the pouches.

   Z-1223-2017 · Root cause: Employee error · FDA record ↗

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.

• MalfunctionJul 12, 2022Entrapment of Device; Detachment of Device or Device Component

  PER THE ORIGINAL DESCRIBED EVENT IN MDR REPORT #: MW5109861, "WHILE ATTEMPTING TO PLACE DOBHOFF BRIDLE, THE MAGNET ON THE LEFT SIDE DETACHED AND LODGED IN THE PATIENT'S NASOPHARYNX. MULTIPLE PROVIDERS ATTEMPTED TO REMOVE IT NON-INVASIVELY BUT WERE UNSUCCESSFUL. THE PATIENT WILL NEED TO UNDERGO ANESTHESIA TO REMOVE, BUT HAS ELECTED TO LEAVE IT IN PLACE UNLESS IT CAUSES PROBLEMS. BILATERAL NASAL CAVITIES ANESTHETIZED WITH A 50/50 SOLUTION OF 4% LIDOCAINE AND 0.05% OXYMETAZOLINE ON 1/2X3" NEURO PATTIES. BILATERAL CAVITIES EXAMINED WITH A 0 DEGREE HOPKINS ROD TELESCOPE. MUCOUS WAS REMOVED FROM THE NASAL CAVITIES AND NASOPHARYNX WITH A FRAZIER TIP SUCTION. NO FOREIGN BODIES WERE IDENTIFIED. FDA SAFETY REPORT ID# (B)(4)."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14996099 ↗

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.