AVANOS 94817Recalls & reported problems
Avanos Medical, Inc. · * MIC* Gastrostomy Feeding Tube · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770948171), received between Aug 30, 2021 and Aug 30, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Material Rupture” (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 16, 2026.
Most reported problems
Device problems
- Material Rupture1
- Migration1
Patient problems
- Abscess1
- Fever1
- Inflammation1
- Pain1
- Peritonitis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 30, 2021Material Rupture; Migration; Material Rupture; Migration
IT WAS REPORTED VIA MW5103303 REC'D ON 7 SEP 2021, "PATIENT CAME TO IR FOR G TUBE EVALUATION IR PHYSICIAN SCANNED PATIENT AND DISCOVERED THE BALLOON FOR THE G TUBE WAS RUPTURED PATIENT RECENTLY HAD G TUBE PLACED 2021 WITH NO ISSUES, IN THE INTERIM SOMEHOW THE BALLOON WAS EXPANDED BEYOND RECOMMENDED INFLATION AND WAS RUPTURED UNABLE TO REPLACE G TUBE DUE TO THE FRESH TRACT OF RECENT PLACEMENT PATIENT BROUGHT BACK TO JR ON 2021 FOR REPLACEMENT OF G TUBE G-TUBE BALLOON RUPTURE THAT ALLOWED TUBE FEEDS TO LEAK INTO ABDOMINAL CAVITY.".
Patient problems: Abscess; Fever; Inflammation; Pain; Peritonitis
MAUDE report 12388249 ↗
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.
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