AMT Initial Placement Dilator SetRecalls & reported problems across all models
Applied Medical Technology, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 2 models of AMT Initial Placement Dilator Set by Applied Medical Technology, Inc. in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Mar 7, 2024 and Jun 4, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Component Missing” (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
Reports received per month, all models
AMT Initial Placement Dilator Set 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.
- May 14, 2024Completed
Devices were labelled with the incorrect guidewire labelling.
Z-2238-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported AMT Initial Placement Dilator Set problems
Device problems
- Component Missing1
- Device Handling Problem1
- No Apparent Adverse Event1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Stomach Ulceration1
AMT Initial Placement Dilator Set models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AMT Initial Placement Dilator Set IP-DILTubes, Gastrointestinal (And Accessories)1 recall1 report
- AMT Initial Placement Dilator Set IP-DILTubes, Gastrointestinal (And Accessories)2 reports
Recent AMT Initial Placement Dilator Set adverse event reports
The 3 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2025No Apparent Adverse Event; Device Handling Problem; No Apparent Adverse Event; Device Handling Problem
PER THE ORIGINAL REPORTER IN UF #: (B)(4), IT WAS REPORTED THAT THE, "DILATOR SET NUMBER #7, DILATOR IN THE PACK DOESN'T HAVE A LUMEN TO GO INTO THE GUIDEWIRE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22141527 ↗MalfunctionMay 19, 2025Component Missing
DILATOR SET NUMBER #7, DILATOR IN THE PACK DOESN'T HAVE A LUMEN TO GO INTO THE GUIDEWIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22043730 ↗InjuryMar 7, 2024Use of Device Problem; Use of Device Problem
THE ORIGINAL REPORTER INDICATED THAT THE PATIENT EXPERIENCED A PERFORATION THROUGH THE POSTERIOR GASTRIC WALL. REPORTED THAT THE PROCEDURE LASTED 5-10 MINUTES FOR G-TUBE INSERTION. THE PATIENT EXPERIENCED SEPTIC SHOCK AND NEED FOR RETURN TO THE OR. ABDOMINAL COMPARTMENT SYNDROME NECESSITATING MULTIPLE TRIPS TO THE OR.
Patient problems: Stomach Ulceration
MAUDE report 18859465 ↗
Other Applied Medical Technology, Inc. products
All Applied Medical Technology, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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