AVANOS 42729Recalls & reported problems
Avanos Medical, Inc. · MIC-KEY* Gastrostomy Feeding Tube Kit, SECUR-LOK* Extension Sets with ENFit® Connector · Class 2 · Implant
Data updated Oct 13, 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 00350770427294), received between Nov 7, 2024 and Feb 19, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Fluid/Blood Leak1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 19, 2026Fluid/Blood Leak
IT WAS REPORTED THERE WAS LEAKAGE AROUND THE TUBE. THE PATIENT WAS PRESCRIBED CALMOSEPTINE AND MUPIROCIN WHICH WAS APPLIED TO ABDOMEN.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 24392189 ↗MalfunctionNov 7, 2024Break; Break
IT WAS REPORTED, ON THE MORNING OF (B)(6) 2024 PATIENT WAS IN BED AND STAFF FOUND THE FRONT OF THE GASTROSTOMY ON THE FLOOR - THE BALLOON IS BELIEVED TO STILL BE IN THE PATIENT. HE WAS ADMITTED TO THE HOSPITAL ON THE (B)(6) 2024 AND HAD A 5 DAY STAY WHILST THIS WAS SORTED. NO HARM TO PATIENT. PER ADDITIONAL INFORMATION RECEIVED ON 10OCT2024, THE FEED PORT SECTION OF TUBE THAT HAS FRACTURED BELOW THE FEED PORT SECTION. PER ADDITIONAL INFORMATION RECEIVED ON 11OCT2024, AN ENDOSCOPY WAS PERFORMED TO LOCATE BALLOON. NO INFORMATION WAS PROVIDED ON WHETHER THE RETAINED PIECE WAS REMOVED OR WILL PASS NATURALLY.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 20629195 ↗
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
- 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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