AMT BridleRecalls & reported problems across all models

We found 4 models of AMT Bridle by Applied Medical Technology, Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Nov 9, 2018 and Jul 12, 2022 — classified as 2 malfunctions.

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

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

AMT Bridle recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 19, 2017Terminated

   Expired expiration dates are listed on the pouches.

   Z-1223-2017 · Root cause: Employee error · names 3 of these models · Recall details · FDA record ↗

Most reported AMT Bridle problems

AMT Bridle models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AMT Bridle™ E4-4110

  Tubes, Gastrointestinal (And Accessories)
  1 recall1 report
• AMT Bridle™ E4-4114

  Tubes, Gastrointestinal (And Accessories)
  1 recall0 reports
• AMT Bridle™ E4-4116

  Tubes, Gastrointestinal (And Accessories)
  1 recall0 reports
• AMT Bridle™ E4-4112

  Tubes, Gastrointestinal (And Accessories)
  1 report

Recent AMT Bridle adverse event reports

The 2 most recent reports across all models, 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 ↗
• 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 ↗

Other Applied Medical Technology, Inc. products

• NutraGlide Nasal Feeding Tube8 models · 3 reports · 9 recalls
• AMT Mini Extension Set3 models · 6 reports · 1 recall
• AMT Mini ONE Extension Set5 models · 4 reports · 1 recall
• AMT Initial Placement Dilator Set2 models · 3 reports · 1 recall
• Mini ONE Balloon Button15 models · 33 reports