AVANOS 95677Recalls & reported problems
Avanos Medical, Inc. · MIC* Jejunostomy Tubes · Class 2 · Implant
- 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 00350770956770), received between Oct 6, 2020 and May 18, 2023 — 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.
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED 30-JUN-2023 STATING THE PHYSICIAN "CAN¿T EVEN CONFIRM THAT THE TUBE WAS RETAINED IN THE PATIENT BUT THAT IS THE APPARENT CLAIM. THE PATIENT DID NOT HAVE SURGERY OR A PROCEDURE TO REMOVE ANYTHING SO THEY¿LL NEVER KNOW IF A REMNANT ACTUALLY REMAINS, BUT IT WAS APPARENTLY NOTED ON A CT [COMPUTED TOMOGRAPHY] SCAN."
Patient problems: Foreign Body In Patient
MAUDE report 16956625 ↗MalfunctionOct 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT UPON REMOVAL OF A JEJUNOSTOMY TUBE UNDER LOCAL ANESTHESIA, IT WAS FOUND THAT PART OF THE PROXIMAL FLANGE WAS MISSING. THE PART WAS RETAINED; THE DECISION WAS TAKEN TO LEAVE INSITU. NO PATIENT INJURY WAS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 10638837 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.