AMT Initial Placement Dilator Set IP-DIL (UDI 00842071131876)Recalls & reported problems
Applied Medical Technology, Inc. · AMT Initial Placement Dilator Kit (Smaller Dia GW) · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842071131876), received between Mar 7, 2024 and Mar 7, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- May 14, 2024Completed
Devices were labelled with the incorrect guidewire labelling.
Z-2238-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Stomach Ulceration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
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- 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
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- 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.