AMT Balloon G-Tube 7-1410Recalls & reported problems
Applied Medical Technology, Inc. · 14FR Balloon G-Tube (Boxed 1) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842071116408), received between Nov 22, 2022 and Nov 22, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 22, 2022Fluid/Blood Leak; Fluid/Blood Leak
PER THE ORIGINAL REPORTER IN FDA REPORT #: (B)(4), "AMT'S BALLOON G-TUBE WILL NOT SECURELY HOLD TUBING FOR FEEDING IN EITHER PORT. WHEN TUBING CONNECTED TO EITHER PORT, IT QUICKLY SLIDES OUT. TUBING IS NEEDING TO BE "TAPED" IN PLACE WHILE FEEDING IS GOING SO THAT PATIENT RECEIVES HIS FEEDING. HEALTH CARE PROVIDER CHECKED IN WITH NURSE, MOM AND PATIENT TODAY. THE PROBLEM SEEMS TO BE AT THE CONNECTION POINT BETWEEN THE ENTERAL END OF THE G-TUBE AND THE CHRISTMAS-TREE-LIKE CONNECTOR OF THE TUBING. THERE IS A CRACK, WHICH IS PREVENTING A TIGHT SEAL. CLINICAL STAFF ARE USING TAPE AND A POSEY TO CREATE A SEAL FOR THE NEXT THREE WEEKS, WHEN THE G-TUBE WILL BE HEALED ENOUGH TO BE ABLE TO CHANGE IT OUT. SURGERY AND NEONATOLOGY ARE AWARE OF THIS PLAN AND APPROVE. HEALTH CARE PROVIDER HAVE PLACED A NOTE AT THE BEDSIDE TO SAVE THIS TUBE FOR OUR PRODUCTS DEPARTMENT FOR EVALUATION FOLLOWING REMOVAL."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15844706 ↗
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-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-05090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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