AVANOS 94838Recalls & reported problems
Avanos Medical, Inc. · MIC-KEY* G Feeding Tube-12-3-4.0 · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770948386), received between Sep 17, 2026 and Sep 17, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Component Missing” (3 reports).
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
Most reported problems
Device problems
- Component Missing3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Component Missing
AVANOS Medical received a single report referencing three different incidents, each associated with a separate unit and event. This is the third of three reports.Refer to (b)(4) for the first event. Refer to (b)(4) for the second event.Refer to (b)(4) for the third event.It was reported the surgeon's kit doesn¿t have a bumper that holds the tube at all. It just lets the tube slide through it. This has resulted in a tube that has gone deep into the stomach, which early on in the post-operative phase "results in the stomach falling away from the abdominal wall and exposure of the tube in and out of the peritoneal cavity as a result."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806198 ↗MalfunctionSep 17, 2026Component Missing
AVANOS Medical received a single report referencing three different incidents, each associated with a separate unit and event. This is the second of three reports.Refer to 2026095-2026-00085 for the first event. Refer to 2026095-2026-00087 for the second event.Refer to 2026095-2026-00088 for the third event.It was reported the surgeon's kit doesn¿t have a bumper that holds the tube at all. It just lets the tube slide through it. This has resulted in a tube that has gone deep into the stomach, which early on in the post-operative phase "results in the stomach falling away from the abdominal wall and exposure of the tube in and out of the peritoneal cavity as a result."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805192 ↗MalfunctionSep 17, 2026Component Missing
AVANOS Medical received a single report referencing three different incidents, each associated with a separate unit and event. This is the first of three reports.Refer to 2026095-2026-00085 for the first event. Refer to 2026095-2026-00087 for the second event.Refer to 2026095-2026-00088 for the third event.It was reported the surgeon's kit doesn¿t have a bumper that holds the tube at all. It just lets the tube slide through it. This has resulted in a tube that has gone deep into the stomach, which early on in the post-operative phase "results in the stomach falling away from the abdominal wall and exposure of the tube in and out of the peritoneal cavity as a result."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805191 ↗
Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices
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- 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
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 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
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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