AMT Initial Placement Dilator Set IP-DIL (UDI 00842071106867)Recalls & reported problems
Applied Medical Technology, Inc. · AMT Initial Placement Dilator Set · Class 2
All models of AMT Initial Placement Dilator Set (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842071106867), received between May 19, 2025 and Jun 4, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component Missing” (1 report).
1 other recall cover devices cleared under the same FDA submission (K073034); 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
- Component Missing1
- Device Handling Problem1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, 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 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K073034. One submission often covers many models, so check the product and lot details in each record.
- Z-2238-2024 · May 14, 2024 · CompletedAMT Initial Placement Dilator Set. Used to place gastrostomy devices.
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.
How reports and recalls are matched · Editorial policy · Report an error on this page